Industry Insider
Clinical and Industry News
March 2006
Boston Scientific beats J&J in Battle for Guidant
Heart device maker Guidant Corp. agreed to be bought by Boston Scientific Corp. for $80 per share, or about $27 billion, and terminated an agreement to be acquired by Johnson & Johnson. The move came hours after J&J, which had been offering to buy Guidant for $71 a share, let a midnight deadline expire without responding to Boston Scientific's rival bid.
In a statement, J&J said it had determined not to increase its last offer for Guidant Corp., because to do so would not have been in the best interest of its shareholders.
The agreement is the latest turn in J&J's 14-month attempt to take control of the maker of implantable heart defibrillators and products used in angioplasty.
As part of the deal, Boston Scientific entered into an agreement with Abbott Laboratories, under which Boston Scientific agreed to divest Guidant's vascular intervention and endovascular businesses, while also agreeing to share rights to Guidant’s drug-eluting stent program.
Corindus, Cath Lab Technology Firm, Strengthens U.S. Presence Corindus, developer of remote control technology for the cardiac catheterization laboratory, announced the opening of U.S. headquarters in Auburndale, MA for the management of sales, marketing and clinical affairs. Originally established in 2002 as NaviCath, the company was founded within the framework of the Technion Entrepreneurial Incubator Company (TEIC) in Haifa, Israel.
Corindus holds a patent for Remote Control Catheterization technology. Its CorPath catheter manipulation system allows physicians to advance and torque coronary guide wires and stent systems in a patient’s artery from a remote location. The system is non-invasive and accommodates all state-of-the-art interventional cath lab devices.
With the increasing volume and complexity of interventional procedures, the health hazards associated with the exposure of physicians and staff to radiation has become a significant concern. As remote control catheterization becomes standard practice, the risks of radiation can be significantly reduced. Additionally, fatigue and back pain, a major problem for operators caused by the need to wear lead radiation protection garments, can be virtually eliminated.
Initial clinical trials with CorPath successfully demonstrated its safety and efficacy. Further clinical study to obtain FDA marketing approval is underway.
CorPath mechanically maneuvers devices through patients’ arteries as specified by the physician at a remote workstation. The proprietary technology utilizes physician fluoroscopic control similar to routine practice to allow maneuvering and torquing of cath lab devices. Initial clinical trials have demonstrated CorPath’s safety and efficacy. Unique to CorPath is the simplicity of integration into existing cath lab systems. The CorPath system requires regulatory clearance and currently is used for investigational purposes only.
The TAXUS Stent System Shows Excellent Results in Small Vessels Boston Scientific announced that the data from its TAXUS Clinical Trial Program, including the meta-analysis, shows excellent efficacy and safety in treatment of small vessels (1
The large-scale, Johnson & Johnson-sponsored REALITY study (n = 1,353 across 88 centers worldwide) directly compared the TAXUS and Cypher* Stent systems in small arteries. The REALITY study confirmed the excellent clinical outcomes with the TAXUS Stent system in small vessels.2
Recently, the de-facto single-center ISAR SMART study compared Taxus and Cypher Stent systems in small vessels, which included patients with arteries similar in size to REALITY but in less complex lesions. This study, conducted by Professor Adnan Kastrati from the German Heart Centre, Technical University, Munich, Germany, failed to prove non-inferiority of the TAXUS versus the Cypher Stents system in small vessels.3
Dr. Donald Baim, Brigham and Women's Hospital, Boston, MA, commented that the data from the small ISAR SMART study is at odds with the large body of evidence from the TAXUS Clinical Trial program, including those data from the small vessel meta-analysis. Dr. Baim further suggested that we should therefore temper the ISAR SMART findings, in which routine angiographic follow-up led to an unheard of 100% rate of conversion from angiographic restenosis to target lesion revascularization, in the TAXUS arm. This pattern suggests that the ‘occulo-stenotic reflex’ was at play, compared to the usual picture of a 50% conversion rate, said Dr. Baim.
According to the evidence-based medicine clinical trial scoring system available on TCTmd.com, the ISAR SMART study scores only 3 out of 10 points and its outcomes should therefore not be used to direct clinical practice.4 Prof. Sigmund Silber, author of the scoring system and Chairperson of the European PCI guidelines, said ISAR SMART study does not have a primary clinical endpoint, is a de-facto single-center experience without validation from an external, independent core catheter lab. Thus, it is attributed a low score according to the scoring system. References 1. TAXUS meta-analysis II, IV, V, VI presented by G. Stone at ACC 2005. 2. REALITY study presented by M.C. Morice at ACC 2005. 3. ISAR SMART is an independent study conducted by Pr Kastrati / Mehilli J, Dibra A, Kastrati A et al. Eur Heart J 2006; online. 4. Silber Score on tctmd.com. 5. Morice MC. Stenting for small coronary vessels. J Invasive Cardiol 2003;15:377-379. * Cypher is a registered trademark of J&J Cordis
Witt Biomedical and GEMMS Announce Marketing and Technology Partnership New Alliance Establishes a Continuum of Care between the Hospital and Ambulatory Cardiology Practice Witt Biomedical, focusing on cardiovascular enterprise technology, and GEMMS, developer of a fully integrated, cardiology-specific electronic clinical information system, announced a marketing and technology partnership to benefit cardiovascular physicians and patients. Witt and GEMMS will discuss the advantages of the new partnership at ACC 2006.
According to Witt Biomedical President Mike Wolfe and GEMMS CEO Rodger P. Pinto, PhD, the alliance presents a unique opportunity for the two companies to create a continuum of care between cardiovascular testing and treatment in the hospital and care provided in the physician practice.
Wolfe explained, Our technologies complement each other in ways that will directly enhance workflow for cardiologists. GEMMS’ single-point decision system in the ambulatory cardiology practice, GEMMS|One, will provide Witt’s cardiovascular enterprise system in the hospital with the patient’s history and procedures, verification of medical necessity, and other information required to create a comprehensive record. In turn, Witt will close the loop by sending the findings of studies, tests and therapies, the transcription report, discreet data, and other pertinent details to GEMMS|One.
Pinto agreed, noting, By sharing information and seamlessly integrating our technologies, we can achieve our shared vision to provide cardiologists with complete access to critical patient information, ranging from the office visit to non-invasive cardiovascular testing to the cath lab and back to the physician practice. This holistic view of each patient’s case will empower the cardiologist to make faster, more confident diagnoses and decisions."
Janus Tacrolimus-Eluting Carbostent Demonstrates Excellent Safety Profile and Clinical Efficacy First Six-month Clinical Findings from e-Janus Registry Presented at JIM Congress in Rome Sorin Group, Europe's largest medical technology company specializing in the treatment of cardiovascular diseases, presented the first six-month clinical results from its e-Janus international "real-world" registry. The data, presented at the Joint Interventional Meeting (JIM) in Rome on February 17, 2006, confirm that the Janus Tacrolimus-eluting Carbostent provides an excellent safety profile and clinical efficacy for the treatment of "real-world" patients, including the high-risk AMI (acute myocardial infarction) patient population.
While still recruiting, the e-Janus registry has currently enrolled over 2500 patients at more than 80 centers worldwide (except the U.S. and Japan). Six-month clinical follow-up on 587 patients were presented by Dr. J. Koolen (Eindhoven, The Netherlands), the Principal Investigator (PI) of the study.
In the overall population analyzed (587 patients), Dr. Koolen reported a 4.3% major adverse cardiac events (MACE) rate and a 3.1% target lesion revascularization (TLR). MACE includes death, myocardial infarction (MI; Q-wave and non-Q-wave) and target lesion revascularization.
Out of the 587 patients who had completed the six-month follow-up, 31% were diabetic patients, 50.4% were patients with multi-vessel disease and 23% percent of patients presented with an acute myocardial infarction.
Dr. Koolen highlighted the results achieved in the AMI patient subset, with a 3.0% MACE rate at six-month follow-up. In these 133 AMI patients, the TLR rate was 2.2% and, more importantly, the late stent thrombosis rate for this high risk subgroup was 0%.
e-Janus is a multi-center, prospective registry, designed to collect real-world clinical outcomes in more than 2500 patients with coronary artery disease at more than 100 centers worldwide, except the U.S. and Japan. e-Janus is based on electronic CRFs, with a 3% site monitoring and with an independent CEC (Clinical Events Committee) reviewing and adjudicating adverse events.
OmniSonic's Resolution® Endovascular System Transitions to Full U.S. Market Release OmniSonics Medical Technologies, Inc. announced that it has transitioned to a full U.S. market release of the Resolution® Endovascular System. The full market release follows the completion of a limited release that commenced upon FDA clearance in December 2005 for use in the treatment of thrombosed, synthetic dialysis access grafts. OmniSonics has initiated the expansion of the treatment of patients at additional healthcare facilities and will continue to roll out the Resolution Endovascular System as the Company's sales and operations infrastructures expand.
In occlusions that varied in age from several weeks to three months, the Resolution Endovascular System consistently re-established flow and resolved the clot in less than six minutes of application time. In addition to clearing aged-mature thrombus, physicians reported successful clot resolution and flow restoration in procedures where the patient was referred for treatment after having previously failed treatment utilizing another percutaneous thrombectomy technique.
The Resolution Endovascular System consists of two primary components: a Generator and a Resolution System Kit. The Resolution System Kit consists of a handpiece with an attached wire and accessory irrigation tubing. The Generator controls an electrical signal to power the handpiece. The handpiece converts the electronic signal to low-power ultrasonic energy transmitted down the length of the Resolution Therapeutic Wire. The Resolution Therapeutic Wire distributes ultrasonic energy waves that generate a cavitational streaming effect that breaks the fibrin bonds. Treatment with the Resolution Endovascular System utilizes typical interventional technique and is compatible with common interventional devices (5Fr and .035" wire compatibility).
Blood Flow Changes Seen in Healthy People at Risk for Heart Disease MRI scans show blood flow within heart muscle are correlated with coronary risk factors heart disease, but no apparent symptoms, have reduced blood vessel responsiveness in the muscle of their hearts that is detectable on MRI scans, according to a new study in the February 7, 2006, issue of the Journal of the American College of Cardiology.
In a population of asymptomatic individuals with low likelihood of obstructive coronary heart disease, we found a relatively strong association with risk factors, which supports the concept that coronary vasoreactivity is reduced before any clinical manifestation of coronary heart disease, said Michael Jerosch-Herold, PhD from the Oregon Health & Science University in Portland, Oregon, and adjunct associate professor at the University of Minnesota, where the MRI studies were conducted from 2001 to 2004.
The results support the idea that impairment in the ability of blood vessels to dilate in response to physical activity or other stress may be one of the earliest signs of coronary heart disease. The study also suggests that MRI scans may help identify people at higher risk for heart disease, but future studies will be needed to determine whether the scans offer predictions that are any better than current models that use age, cholesterol and glucose levels, blood pressure and other known risk factors.
The researchers, including Lu Wang, MD, PhD from the University of Minnesota in Minneapolis, studied 222 men and women, ages 45 to 84 years who were free of a coronary heart disease diagnosis. The participants were among those taking part in the University of Minnesota field center of the Multi-Ethnic Study of Atherosclerosis (MESA). MESA is a study of the progression of cardiovascular disease among people in the general population.
For the first time, MRI scans were used to measure blood flow in the hearts of healthy people. Measurements were made at rest and then after an infusion of adenosine, which triggers a surge in blood flow. Peak blood flow was lower among the participants who were older, had higher blood pressure and fasting glucose levels, and lower HDL cholesterol. In addition, the ratio of peak blood flow to resting flow was associated with blood pressure and cholesterol levels. Finally, participants with higher estimated 10-year risk of developing coronary heart disease had lower peak blow flow and peak-to-resting flow ratios.
Our investigations improve the understanding of the physiology and pathophysiology role of myocardial perfusion in the process of coronary atherosclerosis. Findings from this study also provide important baseline information for future research on the clinical use of perfusion studies, as well as on the subclinical coronary heart disease evaluation, the researchers wrote.
However, this study just took a snapshot view of coronary blood flow in the participants, so future studies will be needed to determine whether MRI scans are useful for predicting heart disease risk.
We do not have outcome data in this population, so the usefulness of myocardial perfusion measurements for the prediction of coronary events could not be established in this study. With the accumulation of data on outcomes, it will be feasible in the future to determine the incremental value of myocardial perfusion measurements for assessing the risk of coronary heart disease, Dr. Jerosch-Herold said.
Joseph B. Selvanayagam, MBBS, FRACP, DPhil from the University of Oxford and John Radcliffe Hospital in Oxford, UK, who was not connected with this study, said it adds to earlier work that indicates changes in coronary blood vessel response may appear before any signs of obstructive coronary artery lesions.
The strength of this work is that it is a population-based study and uses a validated, quantitative MRI-based technique of assessing myocardial blood flow, Dr. Selvanayagam said.
Although these findings support the notion that functional changes in coronary vasculature may occur in asymptomatic adults with coronary artery disease risk factors, we must remember that this study is cross-sectional in design and hence cannot address causality or longitudinal changes over time. For example, how does the treatment of these coronary artery disease risk factors over time alter myocardial perfusion reserve? Is there a difference in the current cohort between untreated and treated patients with high cholesterol or blood pressure? It would have been interesting to see the relationship of these findings to the level of coronary calcification seen in these patients. Nevertheless, these current findings serve as an extremely useful baseline for future studies on myocardial perfusion in both symptomatic and asymptomatic patients with coronary atherosclerosis, he added.
Mark Doyle, PhD from the Allegheny Singer Research Institute in Pittsburgh, Pennsylvania, who also was not connected with this study, said it represents a step towards developing a diagnostic test that may better characterize the health status and risk for individuals.
The major difficulty with risk factor assessment is that while it is fairly effective in predicting death and heart attack rates for large groups of patients, many individuals in the high-risk category will lead long lives, while many individuals in the low-risk category will die prematurely from heart disease. Further, most diagnostic tests that are currently available are designed to detect only advanced disease, Dr. Doyle said.
At this stage, it is too early to show whether this type of MRI scan will prove to be a better prognostic indicator than use of risk factors. However, this paper continues the development of MRI into a technique to provide new diagnostic information, not available with other, more established techniques, he added.
Comparison of Drug-Releasing Coronary Stents Show Similar Effectiveness Use of coronary stents that release the drugs sirolimus or paclitaxel produced similar results in patients with new coronary artery lesions, according to a study in the February 22 issue of the Journal of the American Medical Association.
Marie-Claude Morice, MD, of the Institut Cardiovasculaire Paris Sud, Massy, France and colleagues compared the safety and efficacy of sirolimus-eluting vs. paclitaxel-eluting coronary stents in patients with new coronary artery lesions. The REALITY trial included 1,386 patients with angina pectoris and 1 or 2 new coronary lesions. The study was conducted at 90 hospitals in Europe, Latin America, and Asia between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Patients were randomly assigned to receive a sirolimus-eluting stent or a paclitaxel-eluting stent.
The researchers found that the average restenosis rate, the primary study outcome the researchers were using to compare the stents, was 9.6 percent in the sirolimus-eluting stent group vs. 11.1 percent in the paclitaxel-eluting stent group, a difference that did not reach statistical significance. Likewise, there were no significant differences between the 2 study groups in rates of other in-hospital adverse clinical events, including target vessel revascularization, stent thrombosis, cerebral vascular events, and hemorrhagic complications. The overall, 12-month cumulative rate of major adverse cardiac events was 10.7 percent in the sirolimus-eluting stent group vs. 11.4 percent in the paclitaxel-eluting stent group.
A longer follow-up may be required for the different degrees of neointimal proliferation suppression to translate into significantly different rates of binary restenosis or adverse clinical events, the authors conclude.
In an accompanying editorial, Sorin J. Brener, MD, of the Cleveland Clinic Lerner College of Medicine, Cleveland, comments on the study by Morice et al. Further analyses and studies are needed to learn about the effect of stent choice in patients with diabetes and those with long or bifurcating lesions. More importantly, extended follow-up over 24 months may answer 2 critical clinical questions: Will the better inhibition of neointimal proliferation with sirolimus-eluting stents eventually result in a clinically meaningful improvement in outcome? And will the choice of stent affect the incidence of late stent thrombosis after discontinuation of dual antiplatelet therapy? Answers to these 2 questions may well determine the specific way these very helpful devices can be used best. Source: JAMA. 2006;295:895-904, 937-938.
ARRT Schedules Third Exam Administration July 13 is Next Exam Date for Radiologist Assistant Certification The next opportunity for qualified candidates to sit for the ARRT Radiologist Assistant exam is Thursday, July 13, 2006. Applications must be postmarked by Thursday, May 18, 2006. The exam will not be scheduled again until early 2007, after which ARRT plans to offer it twice yearly.
ARRT recently established a temporary eligibility pathway for Radiology Practitioner Assistants (RPAs) to earn ARRT’s Registered Radiologist Assistant (R.R.A.) credential. The RPA pathway expires December 31, 2007, after which all candidates must directly meet all ARRT requirements.
Details on eligibility requirements and application procedures for all candidates can be found on the Radiologist Assistant page at www.arrt.org. (Application materials for RPA candidates are located under RPA Pathway.) Candidates may also phone ARRT at (651) 687-0048, ext. 560, to request an application or clarify eligibility.
The American Registry of Radiologic Technologists promotes high standards of patient care by recognizing qualified individuals in medical imaging, interventional procedures, and radiation therapy. Headquartered in St. Paul, Minnesota, ARRT evaluates, certifies, and annually registers more than 257,000 radiologic technologists across the United States.
MI, Osteoporosis Linked in Men Over 50 Men who have survived a heart attack are at increased risk of bone loss and osteoporosis in later life, says Tulane University researcher Jeanette H. Magnus. She analyzed data from 5,050 men and women 50-79 years old who participated in the 3rd National Health and Nutrition Examination Survey between 1988-1994. In addition to the increased risk of bone density loss after a heart attack, the researchers found that cigarette smoking, lack of physical activity and being overweight were all predictive of bone density loss in men.
AngioJet® Therapy Shown Safe and Effective As Part of Rescue Percutaneous Coronary Interventions Study Shows Interventional Techniques, Including AngioJet® Therapy for Significant Thrombus, Can Be Performed with Excellent Outcomes in High-Risk Patients Following Failed Clot-Busting Drug Therapy
Possis Medical, Inc., announced the recent publication of an important clinical study that included its AngioJet® Rheolytic Thrombectomy Catheter System. The study evaluated clinical outcomes in high-risk acute coronary syndrome (ACS) patients whose initial treatment with thrombolytic (clot-busting) drugs had failed, and who therefore required urgent, rescue percutaneous catheter-based intervention (PCI). The study was conducted by Dr. Ray Matthews and his colleagues at Good Samaritan Hospital and the UCLA Medical Center in Los Angeles. It appears in the February 2006 issue of Catheterization and Cardiovascular Interventions. Over 200 patients were included in the study; 21 percent of these received AngioJet treatment as part of the rescue PCI. The authors concluded in part: This observational, consecutive, real-world study of contemporary rescue PCI for failed thrombolysis shows a high use of coronary stents, Rheolytic thrombectomy, glycoprotein IIb/IIIa inhibitors, and intraortic balloon pump placement. Angiographic and clinical success was high with low bleeding complications and low in-hospital mortality.
Dr. Matthews will participate in a roundtable discussion of AngioJet coronary thrombectomy by leading interventional cardiologists, hosted by Possis Medical, at the March annual meeting of the American College of Cardiology. Abbott Launches New Specialty Catheter Technology in U.S. Abbott announced the introduction of a new specialty catheter known as the Asahi Tornus® specialty catheter. This stainless steel catheter is engineered to deliver therapeutic, minimally invasive balloon catheters and stents to vessels blocked with chronic occlusions. The Tornus, which was cleared for marketing by the U.S. FDA, was launched at the Third International Chronic Total Occlusion Summit.
The Tornus stainless steel catheter gives us more support for accessing a type of occlusion that for decades has represented a major frustration for interventionalists, said Gregg W. Stone, MD, Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York. About 15 percent of the patients we see have this type of a blockage. The Tornus catheter allows us to cross dense areas of vessel blockage so they can be successfully dilated and stented.
The Tornus catheter is made of stainless steel to provide extra support during operator handling. The proprietary Tornus design consists of several hair-thin, stainless steel strands braided together to enhance flexibility and strength, along with a safety-release valve at the proximal end to indicate when the device has reached maximum rotation, and a specialized tapered distal tip with a radio-opaque marker for optimal visualization in navigating difficult-to-access areas. The device is available in two sizes: 2.1 Fr for accessing lesions that are more difficult to navigate and 2.6 Fr for circumstances requiring more support to push through the lesion.
The Tornus is manufactured by Japan-based Asahi Intecc Co., Ltd. Abbott has a licensing agreement with Asahi Intecc to distribute its guidewires in the U.S. and certain countries worldwide.
In a statement, J&J said it had determined not to increase its last offer for Guidant Corp., because to do so would not have been in the best interest of its shareholders.
The agreement is the latest turn in J&J's 14-month attempt to take control of the maker of implantable heart defibrillators and products used in angioplasty.
As part of the deal, Boston Scientific entered into an agreement with Abbott Laboratories, under which Boston Scientific agreed to divest Guidant's vascular intervention and endovascular businesses, while also agreeing to share rights to Guidant’s drug-eluting stent program.
Corindus, Cath Lab Technology Firm, Strengthens U.S. Presence Corindus, developer of remote control technology for the cardiac catheterization laboratory, announced the opening of U.S. headquarters in Auburndale, MA for the management of sales, marketing and clinical affairs. Originally established in 2002 as NaviCath, the company was founded within the framework of the Technion Entrepreneurial Incubator Company (TEIC) in Haifa, Israel.
Corindus holds a patent for Remote Control Catheterization technology. Its CorPath catheter manipulation system allows physicians to advance and torque coronary guide wires and stent systems in a patient’s artery from a remote location. The system is non-invasive and accommodates all state-of-the-art interventional cath lab devices.
With the increasing volume and complexity of interventional procedures, the health hazards associated with the exposure of physicians and staff to radiation has become a significant concern. As remote control catheterization becomes standard practice, the risks of radiation can be significantly reduced. Additionally, fatigue and back pain, a major problem for operators caused by the need to wear lead radiation protection garments, can be virtually eliminated.
Initial clinical trials with CorPath successfully demonstrated its safety and efficacy. Further clinical study to obtain FDA marketing approval is underway.
CorPath mechanically maneuvers devices through patients’ arteries as specified by the physician at a remote workstation. The proprietary technology utilizes physician fluoroscopic control similar to routine practice to allow maneuvering and torquing of cath lab devices. Initial clinical trials have demonstrated CorPath’s safety and efficacy. Unique to CorPath is the simplicity of integration into existing cath lab systems. The CorPath system requires regulatory clearance and currently is used for investigational purposes only.
The TAXUS Stent System Shows Excellent Results in Small Vessels Boston Scientific announced that the data from its TAXUS Clinical Trial Program, including the meta-analysis, shows excellent efficacy and safety in treatment of small vessels (1
The large-scale, Johnson & Johnson-sponsored REALITY study (n = 1,353 across 88 centers worldwide) directly compared the TAXUS and Cypher* Stent systems in small arteries. The REALITY study confirmed the excellent clinical outcomes with the TAXUS Stent system in small vessels.2
Recently, the de-facto single-center ISAR SMART study compared Taxus and Cypher Stent systems in small vessels, which included patients with arteries similar in size to REALITY but in less complex lesions. This study, conducted by Professor Adnan Kastrati from the German Heart Centre, Technical University, Munich, Germany, failed to prove non-inferiority of the TAXUS versus the Cypher Stents system in small vessels.3
Dr. Donald Baim, Brigham and Women's Hospital, Boston, MA, commented that the data from the small ISAR SMART study is at odds with the large body of evidence from the TAXUS Clinical Trial program, including those data from the small vessel meta-analysis. Dr. Baim further suggested that we should therefore temper the ISAR SMART findings, in which routine angiographic follow-up led to an unheard of 100% rate of conversion from angiographic restenosis to target lesion revascularization, in the TAXUS arm. This pattern suggests that the ‘occulo-stenotic reflex’ was at play, compared to the usual picture of a 50% conversion rate, said Dr. Baim.
According to the evidence-based medicine clinical trial scoring system available on TCTmd.com, the ISAR SMART study scores only 3 out of 10 points and its outcomes should therefore not be used to direct clinical practice.4 Prof. Sigmund Silber, author of the scoring system and Chairperson of the European PCI guidelines, said ISAR SMART study does not have a primary clinical endpoint, is a de-facto single-center experience without validation from an external, independent core catheter lab. Thus, it is attributed a low score according to the scoring system. References 1. TAXUS meta-analysis II, IV, V, VI presented by G. Stone at ACC 2005. 2. REALITY study presented by M.C. Morice at ACC 2005. 3. ISAR SMART is an independent study conducted by Pr Kastrati / Mehilli J, Dibra A, Kastrati A et al. Eur Heart J 2006; online. 4. Silber Score on tctmd.com. 5. Morice MC. Stenting for small coronary vessels. J Invasive Cardiol 2003;15:377-379. * Cypher is a registered trademark of J&J Cordis
Witt Biomedical and GEMMS Announce Marketing and Technology Partnership New Alliance Establishes a Continuum of Care between the Hospital and Ambulatory Cardiology Practice Witt Biomedical, focusing on cardiovascular enterprise technology, and GEMMS, developer of a fully integrated, cardiology-specific electronic clinical information system, announced a marketing and technology partnership to benefit cardiovascular physicians and patients. Witt and GEMMS will discuss the advantages of the new partnership at ACC 2006.
According to Witt Biomedical President Mike Wolfe and GEMMS CEO Rodger P. Pinto, PhD, the alliance presents a unique opportunity for the two companies to create a continuum of care between cardiovascular testing and treatment in the hospital and care provided in the physician practice.
Wolfe explained, Our technologies complement each other in ways that will directly enhance workflow for cardiologists. GEMMS’ single-point decision system in the ambulatory cardiology practice, GEMMS|One, will provide Witt’s cardiovascular enterprise system in the hospital with the patient’s history and procedures, verification of medical necessity, and other information required to create a comprehensive record. In turn, Witt will close the loop by sending the findings of studies, tests and therapies, the transcription report, discreet data, and other pertinent details to GEMMS|One.
Pinto agreed, noting, By sharing information and seamlessly integrating our technologies, we can achieve our shared vision to provide cardiologists with complete access to critical patient information, ranging from the office visit to non-invasive cardiovascular testing to the cath lab and back to the physician practice. This holistic view of each patient’s case will empower the cardiologist to make faster, more confident diagnoses and decisions."
Janus Tacrolimus-Eluting Carbostent Demonstrates Excellent Safety Profile and Clinical Efficacy First Six-month Clinical Findings from e-Janus Registry Presented at JIM Congress in Rome Sorin Group, Europe's largest medical technology company specializing in the treatment of cardiovascular diseases, presented the first six-month clinical results from its e-Janus international "real-world" registry. The data, presented at the Joint Interventional Meeting (JIM) in Rome on February 17, 2006, confirm that the Janus Tacrolimus-eluting Carbostent provides an excellent safety profile and clinical efficacy for the treatment of "real-world" patients, including the high-risk AMI (acute myocardial infarction) patient population.
While still recruiting, the e-Janus registry has currently enrolled over 2500 patients at more than 80 centers worldwide (except the U.S. and Japan). Six-month clinical follow-up on 587 patients were presented by Dr. J. Koolen (Eindhoven, The Netherlands), the Principal Investigator (PI) of the study.
In the overall population analyzed (587 patients), Dr. Koolen reported a 4.3% major adverse cardiac events (MACE) rate and a 3.1% target lesion revascularization (TLR). MACE includes death, myocardial infarction (MI; Q-wave and non-Q-wave) and target lesion revascularization.
Out of the 587 patients who had completed the six-month follow-up, 31% were diabetic patients, 50.4% were patients with multi-vessel disease and 23% percent of patients presented with an acute myocardial infarction.
Dr. Koolen highlighted the results achieved in the AMI patient subset, with a 3.0% MACE rate at six-month follow-up. In these 133 AMI patients, the TLR rate was 2.2% and, more importantly, the late stent thrombosis rate for this high risk subgroup was 0%.
e-Janus is a multi-center, prospective registry, designed to collect real-world clinical outcomes in more than 2500 patients with coronary artery disease at more than 100 centers worldwide, except the U.S. and Japan. e-Janus is based on electronic CRFs, with a 3% site monitoring and with an independent CEC (Clinical Events Committee) reviewing and adjudicating adverse events.
OmniSonic's Resolution® Endovascular System Transitions to Full U.S. Market Release OmniSonics Medical Technologies, Inc. announced that it has transitioned to a full U.S. market release of the Resolution® Endovascular System. The full market release follows the completion of a limited release that commenced upon FDA clearance in December 2005 for use in the treatment of thrombosed, synthetic dialysis access grafts. OmniSonics has initiated the expansion of the treatment of patients at additional healthcare facilities and will continue to roll out the Resolution Endovascular System as the Company's sales and operations infrastructures expand.
In occlusions that varied in age from several weeks to three months, the Resolution Endovascular System consistently re-established flow and resolved the clot in less than six minutes of application time. In addition to clearing aged-mature thrombus, physicians reported successful clot resolution and flow restoration in procedures where the patient was referred for treatment after having previously failed treatment utilizing another percutaneous thrombectomy technique.
The Resolution Endovascular System consists of two primary components: a Generator and a Resolution System Kit. The Resolution System Kit consists of a handpiece with an attached wire and accessory irrigation tubing. The Generator controls an electrical signal to power the handpiece. The handpiece converts the electronic signal to low-power ultrasonic energy transmitted down the length of the Resolution Therapeutic Wire. The Resolution Therapeutic Wire distributes ultrasonic energy waves that generate a cavitational streaming effect that breaks the fibrin bonds. Treatment with the Resolution Endovascular System utilizes typical interventional technique and is compatible with common interventional devices (5Fr and .035" wire compatibility).
Blood Flow Changes Seen in Healthy People at Risk for Heart Disease MRI scans show blood flow within heart muscle are correlated with coronary risk factors heart disease, but no apparent symptoms, have reduced blood vessel responsiveness in the muscle of their hearts that is detectable on MRI scans, according to a new study in the February 7, 2006, issue of the Journal of the American College of Cardiology.
In a population of asymptomatic individuals with low likelihood of obstructive coronary heart disease, we found a relatively strong association with risk factors, which supports the concept that coronary vasoreactivity is reduced before any clinical manifestation of coronary heart disease, said Michael Jerosch-Herold, PhD from the Oregon Health & Science University in Portland, Oregon, and adjunct associate professor at the University of Minnesota, where the MRI studies were conducted from 2001 to 2004.
The results support the idea that impairment in the ability of blood vessels to dilate in response to physical activity or other stress may be one of the earliest signs of coronary heart disease. The study also suggests that MRI scans may help identify people at higher risk for heart disease, but future studies will be needed to determine whether the scans offer predictions that are any better than current models that use age, cholesterol and glucose levels, blood pressure and other known risk factors.
The researchers, including Lu Wang, MD, PhD from the University of Minnesota in Minneapolis, studied 222 men and women, ages 45 to 84 years who were free of a coronary heart disease diagnosis. The participants were among those taking part in the University of Minnesota field center of the Multi-Ethnic Study of Atherosclerosis (MESA). MESA is a study of the progression of cardiovascular disease among people in the general population.
For the first time, MRI scans were used to measure blood flow in the hearts of healthy people. Measurements were made at rest and then after an infusion of adenosine, which triggers a surge in blood flow. Peak blood flow was lower among the participants who were older, had higher blood pressure and fasting glucose levels, and lower HDL cholesterol. In addition, the ratio of peak blood flow to resting flow was associated with blood pressure and cholesterol levels. Finally, participants with higher estimated 10-year risk of developing coronary heart disease had lower peak blow flow and peak-to-resting flow ratios.
Our investigations improve the understanding of the physiology and pathophysiology role of myocardial perfusion in the process of coronary atherosclerosis. Findings from this study also provide important baseline information for future research on the clinical use of perfusion studies, as well as on the subclinical coronary heart disease evaluation, the researchers wrote.
However, this study just took a snapshot view of coronary blood flow in the participants, so future studies will be needed to determine whether MRI scans are useful for predicting heart disease risk.
We do not have outcome data in this population, so the usefulness of myocardial perfusion measurements for the prediction of coronary events could not be established in this study. With the accumulation of data on outcomes, it will be feasible in the future to determine the incremental value of myocardial perfusion measurements for assessing the risk of coronary heart disease, Dr. Jerosch-Herold said.
Joseph B. Selvanayagam, MBBS, FRACP, DPhil from the University of Oxford and John Radcliffe Hospital in Oxford, UK, who was not connected with this study, said it adds to earlier work that indicates changes in coronary blood vessel response may appear before any signs of obstructive coronary artery lesions.
The strength of this work is that it is a population-based study and uses a validated, quantitative MRI-based technique of assessing myocardial blood flow, Dr. Selvanayagam said.
Although these findings support the notion that functional changes in coronary vasculature may occur in asymptomatic adults with coronary artery disease risk factors, we must remember that this study is cross-sectional in design and hence cannot address causality or longitudinal changes over time. For example, how does the treatment of these coronary artery disease risk factors over time alter myocardial perfusion reserve? Is there a difference in the current cohort between untreated and treated patients with high cholesterol or blood pressure? It would have been interesting to see the relationship of these findings to the level of coronary calcification seen in these patients. Nevertheless, these current findings serve as an extremely useful baseline for future studies on myocardial perfusion in both symptomatic and asymptomatic patients with coronary atherosclerosis, he added.
Mark Doyle, PhD from the Allegheny Singer Research Institute in Pittsburgh, Pennsylvania, who also was not connected with this study, said it represents a step towards developing a diagnostic test that may better characterize the health status and risk for individuals.
The major difficulty with risk factor assessment is that while it is fairly effective in predicting death and heart attack rates for large groups of patients, many individuals in the high-risk category will lead long lives, while many individuals in the low-risk category will die prematurely from heart disease. Further, most diagnostic tests that are currently available are designed to detect only advanced disease, Dr. Doyle said.
At this stage, it is too early to show whether this type of MRI scan will prove to be a better prognostic indicator than use of risk factors. However, this paper continues the development of MRI into a technique to provide new diagnostic information, not available with other, more established techniques, he added.
Comparison of Drug-Releasing Coronary Stents Show Similar Effectiveness Use of coronary stents that release the drugs sirolimus or paclitaxel produced similar results in patients with new coronary artery lesions, according to a study in the February 22 issue of the Journal of the American Medical Association.
Marie-Claude Morice, MD, of the Institut Cardiovasculaire Paris Sud, Massy, France and colleagues compared the safety and efficacy of sirolimus-eluting vs. paclitaxel-eluting coronary stents in patients with new coronary artery lesions. The REALITY trial included 1,386 patients with angina pectoris and 1 or 2 new coronary lesions. The study was conducted at 90 hospitals in Europe, Latin America, and Asia between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Patients were randomly assigned to receive a sirolimus-eluting stent or a paclitaxel-eluting stent.
The researchers found that the average restenosis rate, the primary study outcome the researchers were using to compare the stents, was 9.6 percent in the sirolimus-eluting stent group vs. 11.1 percent in the paclitaxel-eluting stent group, a difference that did not reach statistical significance. Likewise, there were no significant differences between the 2 study groups in rates of other in-hospital adverse clinical events, including target vessel revascularization, stent thrombosis, cerebral vascular events, and hemorrhagic complications. The overall, 12-month cumulative rate of major adverse cardiac events was 10.7 percent in the sirolimus-eluting stent group vs. 11.4 percent in the paclitaxel-eluting stent group.
A longer follow-up may be required for the different degrees of neointimal proliferation suppression to translate into significantly different rates of binary restenosis or adverse clinical events, the authors conclude.
In an accompanying editorial, Sorin J. Brener, MD, of the Cleveland Clinic Lerner College of Medicine, Cleveland, comments on the study by Morice et al. Further analyses and studies are needed to learn about the effect of stent choice in patients with diabetes and those with long or bifurcating lesions. More importantly, extended follow-up over 24 months may answer 2 critical clinical questions: Will the better inhibition of neointimal proliferation with sirolimus-eluting stents eventually result in a clinically meaningful improvement in outcome? And will the choice of stent affect the incidence of late stent thrombosis after discontinuation of dual antiplatelet therapy? Answers to these 2 questions may well determine the specific way these very helpful devices can be used best. Source: JAMA. 2006;295:895-904, 937-938.
ARRT Schedules Third Exam Administration July 13 is Next Exam Date for Radiologist Assistant Certification The next opportunity for qualified candidates to sit for the ARRT Radiologist Assistant exam is Thursday, July 13, 2006. Applications must be postmarked by Thursday, May 18, 2006. The exam will not be scheduled again until early 2007, after which ARRT plans to offer it twice yearly.
ARRT recently established a temporary eligibility pathway for Radiology Practitioner Assistants (RPAs) to earn ARRT’s Registered Radiologist Assistant (R.R.A.) credential. The RPA pathway expires December 31, 2007, after which all candidates must directly meet all ARRT requirements.
Details on eligibility requirements and application procedures for all candidates can be found on the Radiologist Assistant page at www.arrt.org. (Application materials for RPA candidates are located under RPA Pathway.) Candidates may also phone ARRT at (651) 687-0048, ext. 560, to request an application or clarify eligibility.
The American Registry of Radiologic Technologists promotes high standards of patient care by recognizing qualified individuals in medical imaging, interventional procedures, and radiation therapy. Headquartered in St. Paul, Minnesota, ARRT evaluates, certifies, and annually registers more than 257,000 radiologic technologists across the United States.
MI, Osteoporosis Linked in Men Over 50 Men who have survived a heart attack are at increased risk of bone loss and osteoporosis in later life, says Tulane University researcher Jeanette H. Magnus. She analyzed data from 5,050 men and women 50-79 years old who participated in the 3rd National Health and Nutrition Examination Survey between 1988-1994. In addition to the increased risk of bone density loss after a heart attack, the researchers found that cigarette smoking, lack of physical activity and being overweight were all predictive of bone density loss in men.
AngioJet® Therapy Shown Safe and Effective As Part of Rescue Percutaneous Coronary Interventions Study Shows Interventional Techniques, Including AngioJet® Therapy for Significant Thrombus, Can Be Performed with Excellent Outcomes in High-Risk Patients Following Failed Clot-Busting Drug Therapy
Possis Medical, Inc., announced the recent publication of an important clinical study that included its AngioJet® Rheolytic Thrombectomy Catheter System. The study evaluated clinical outcomes in high-risk acute coronary syndrome (ACS) patients whose initial treatment with thrombolytic (clot-busting) drugs had failed, and who therefore required urgent, rescue percutaneous catheter-based intervention (PCI). The study was conducted by Dr. Ray Matthews and his colleagues at Good Samaritan Hospital and the UCLA Medical Center in Los Angeles. It appears in the February 2006 issue of Catheterization and Cardiovascular Interventions. Over 200 patients were included in the study; 21 percent of these received AngioJet treatment as part of the rescue PCI. The authors concluded in part: This observational, consecutive, real-world study of contemporary rescue PCI for failed thrombolysis shows a high use of coronary stents, Rheolytic thrombectomy, glycoprotein IIb/IIIa inhibitors, and intraortic balloon pump placement. Angiographic and clinical success was high with low bleeding complications and low in-hospital mortality.
Dr. Matthews will participate in a roundtable discussion of AngioJet coronary thrombectomy by leading interventional cardiologists, hosted by Possis Medical, at the March annual meeting of the American College of Cardiology. Abbott Launches New Specialty Catheter Technology in U.S. Abbott announced the introduction of a new specialty catheter known as the Asahi Tornus® specialty catheter. This stainless steel catheter is engineered to deliver therapeutic, minimally invasive balloon catheters and stents to vessels blocked with chronic occlusions. The Tornus, which was cleared for marketing by the U.S. FDA, was launched at the Third International Chronic Total Occlusion Summit.
The Tornus stainless steel catheter gives us more support for accessing a type of occlusion that for decades has represented a major frustration for interventionalists, said Gregg W. Stone, MD, Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York. About 15 percent of the patients we see have this type of a blockage. The Tornus catheter allows us to cross dense areas of vessel blockage so they can be successfully dilated and stented.
The Tornus catheter is made of stainless steel to provide extra support during operator handling. The proprietary Tornus design consists of several hair-thin, stainless steel strands braided together to enhance flexibility and strength, along with a safety-release valve at the proximal end to indicate when the device has reached maximum rotation, and a specialized tapered distal tip with a radio-opaque marker for optimal visualization in navigating difficult-to-access areas. The device is available in two sizes: 2.1 Fr for accessing lesions that are more difficult to navigate and 2.6 Fr for circumstances requiring more support to push through the lesion.
The Tornus is manufactured by Japan-based Asahi Intecc Co., Ltd. Abbott has a licensing agreement with Asahi Intecc to distribute its guidewires in the U.S. and certain countries worldwide.
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