Clinical and Industry News I

Boston Scientific Announces European Launch of Its TAXUS Paclitaxel-Eluting Stent System Boston Scientific Corporation announced that it has initiated the launch of its TAXUS® paclitaxel-eluting stent system in Europe and other international markets. It plans to launch the product in the United States later this year. The TAXUS product will use the Express2 coronary stent system as its platform. The Express2 system was launched in the United States in mid-September. Since then, Boston Scientific has approximately quadrupled its share of the U.S. stent market. The TAXUS clinical program is a series of studies designed to collect data on Boston Scientific’s proprietary polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis. Prior studies have demonstrated promising results by dramatically reducing restenosis. The proprietary polymer on the stent allows for controlled delivery of paclitaxel. Paclitaxel is a multi-functional microtubular inhibitor that controls platelets, smooth muscle cells and white blood cells, all of which are believed to contribute to restenosis. The Company initiated the TAXUS program in 1997. The TAXUS I trial confirmed safety and reported zero thrombosis and zero restenosis. The TAXUS II trial studied the treatment of de novo coronary lesions and demonstrated both safety and efficacy using the slow- and moderate-release formulations. Significant improvements were seen for clinical, angiographic and intravascular measures of stent performance compared with the bare control stent. The TAXUS III trial, which studied the treatment of in-stent restenosis, confirmed safety and reported no thrombosis. The TAXUS IV trial has completed enrollment and nine-month follow-up is underway. This study is designed to assess the safety and efficacy of a slow-release formulation to support regulatory filings for U.S. product commercialization. The TAXUS V trial has received conditional approval from the U.S. Food and Drug Administration to enroll patients and will study a higher risk patient population than TAXUS IV, including patients with smaller vessels and longer lesions. TAXUS VI is studying patients with complex coronary artery disease and recently completed enrollment. Boston Scientific has also initiated a transitional registry program (WISDOM) in a number of countries as part of a limited commercial launch of its TAXUS paclitaxel-eluting stent system. The TAXUS system is the subject of an Investigational Device Exemption and is not currently available for commercial distribution in the United States. St. Jude Medical Plans Mid-year Global Launch of Next-Generation Angio-Seal Vascular Closure Device St. Jude Medical, Inc. plans a mid-year global launch of the Angio-Seal STS Plus, the company's latest-generation vascular closure device that has recently received U.S. FDA approval. The STS Plus offers enhancements to St. Jude Medical’s Angio-Seal device, with more efficient device positioning, smoother arterial access and other new features. The St. Jude Medical Angio-Seal STS Plus will be offered in both 6 and 8 French configurations and is indicated for use in closing femoral arterial puncture sites following diagnostic or interventional catheterization procedures. The STS Plus builds on the STS Platform, which features a self-tightening suture that allows the arterial closure procedure to be completed in the catheterization lab. The Angio-Seal STS Plus incorporates a redesigned arteriotomy locator and insertion sheath system. The new design allows for improved positioning of the insertion sheath in the artery prior to deployment, helping to ensure that the sheath is in an ideal location for setting the anchor and sealing the puncture. The new arteriotomy locator system also reduces the chance of arterial trauma, helping maintain the arteriotomy in optimal condition for mechanical closure. St. Jude Medical Receives CE Marking for Single-Coil Defibrillation Lead New Riata® ICD Lead is Thinnest Defibrillation Lead Available St. Jude Medical, Inc. has received European CE Marking approval of its new Riata® single-coil defibrillation lead. With CE Marking, these implantable cardioverter defibrillator (ICD) leads may now be sold in all countries of the European Union. Initially released in 2002, the St. Jude Medical Riata defibrillation lead was previously available in only a dual-coil model. The Riata ICD lead, the thinnest ICD lead on the market, addresses physician preference for a single-coil versus a dual-coil model. The Riata single-coil lead is available in two models: Model 1572, a passive-fixation lead, which affixes within the heart using tines; and Model 1582, an active-fixation lead, which affixes in the heart using an extendable-retractable helix mechanism. The decision to use active versus passive fixation depends in part on physician preference and the morphology of the heart. Like the dual-coil Riata lead, the new single-coil models are both true bipolar leads and require an 8 French introducer. Their isodiametric body diameter is just 2.2 mm, making them the thinnest ICD leads available. These multi-lumen silicone leads offer St. Jude Medical's Fast-Pass® coating for improved lubricity. Free White Paper: An Evidence-Based Approach to Managing the Cath Lab: Delivering Stellar Patient Outcomes, Customer Satisfaction, and Financial Success in the Era of Drug-Eluting Stents Lumedx Corporation, an independent provider of cardiovascular information system software and integrated solutions, announces a free white paper: An Evidence-Based Approach to Managing the Cath Lab: Delivering Stellar Patient Outcomes, Customer Satisfaction, and Financial Success in the Era of Drug-Eluting Stents. An Evidence-Based Approach to Managing the Cath Lab describes how to go about equipping today’s cath lab with the processes, people, and technologies to obtain point- of-care data that is accurate, retrievable and useful contributing to outstanding patient care while containing costs. To receive a free copy, surf www.lumedx.com/journey. Written for physicians, clinicians, and cath lab administrators, An Evidence-Based Approach to Managing the Cath Lab explains that the accomplishment of a true performance/financial improvement process in the cath lab will provide the mechanism to recognize point-of-care issues and clinical practice patterns that affect both quality and cost, as well as customer satisfaction. The link between quality and cost must be revealed in retrievable data points. Key white paper highlights include how to develop techniques to create a sound, manageable performance improvement/financial management program: Identification of monitors Data collection methods Appropriate staff and competencies for data collection Technology to collect and archive data Data analysis and reporting techniques Reporting of outcome data Author Donna Nash is an accomplished heath professions educator, author and practicing clinician. With 26 years clinical experience, Mrs. Nash has served for the past 14 years as Director of Cath Labs, Cardiology and Cardiac Rehab Departments in both the for-profit and not-for profit sectors. Currently, she is a Cardiovascular Service-Line Director in a community hospital in Southern California. For more information, please visit www.lumedx.com FDA Clears New Test That Helps Physicians Determine Whether Aspirin is Working in Patients to Prevent Heart Attack and Stroke A new diagnostic test was recently cleared by the FDA which will help doctors determine whether daily aspirin therapy is working in patients at risk for life-threatening cardiovascular events. More than 20 million Americans rely on an aspirin a day to prevent initial and recurrent heart attacks, strokes and other vascular events. However, published data in medical literature indicate that as many as 30% of these patients may not receive aspirin’s full benefit. Additionally, data have shown that these patients are at increased risk for a life-threatening event. A test called the Ultegra® Rapid Platelet Function Assay (RPFA-ASA) uses a computer-based analyzer, single-use disposable cartridges, and a small blood sample to provide physicians with information to determine whether patients are receiving the full benefit of aspirin. The test takes about 10 minutes to complete and is currently available. The Ultegra® RPFA-ASA cartridges measure platelet aggregation (binding) in blood samples as an increase in light transmittance. The system induces platelets in the blood sample to activate and bind together with micro-beads coated with fibrinogen contained in the cartridge. When this happens, light transmittance in the cartridge increases and the system indicates that a patient’s platelets were not affected by aspirin’s anti-platelet action. More information about the Ultegra® RPFA-ASA is available at www.aspirintest.com Medtronic Announces Start of Clinical Trial to Evaluate Its Exponent Self-Expanding Carotid Stent System Medtronic, Inc. announced that it has started enrollment for its pivotal clinical trial to evaluate the safety and performance of its Exponent self-expanding carotid stent system. Carotid stenting offers the potential for a less invasive alternative to an endarterectomy, a potentially high-risk surgical procedure and the current standard of care for treating blockages in the carotid arteries. The Exponent Carotid Stent System will be used in conjunction with the company's embolic protection device the GuardWire® Temporary Occlusion and Aspiration System to assess the safety and efficacy of carotid stenting with carotid artery stenosis. MAVErIC II (Evaluation of the Medtronic AVE Self-Expandable Carotid Stent System with Distal Protection In the Treatment of Carotid Stenosis) represents the pivotal phase of the trial designed to evaluate the short- and long-term safety and efficacy of Medtronic’s Exponent stent system and the GuardWire device in reducing the incidence of stroke and death in patients with either symptomatic or asymptomatic atherosclerotic disease of the carotid arteries. The MAVErIC II trial is led by co-principal investigators: Stephen R. Ramee, MD, FACC, Director of the Cardiac Catheterization Laboratory at the Ochsner Clinic Foundation, New Orleans, and Randall T. Higashida, MD, Clinical Professor of Radiology and Neurological Surgery at the University of California’s San Francisco Campus. The first MAVErIC II patient enrollment was initiated by James D. Joye, DO, FACC, Director of the Cardiac Catheterization Laboratory at El Camino Hospital in Mountain View, Calif. This phase of the trial will include 300 patients whose clinical status will be monitored at one month, six months and one year following the placement of the stent. The initiation of the MAVErIC II pivotal trial demonstrates our commitment to treat diseases of the peripheral vasculature, said Bill Hawkins, president of Medtronic's Vascular Division. Just as we pioneered the use of embolic protection in conjunction with coronary angioplasty, I believe our technology has the potential to set the standard in treating carotid stenosis. The Exponent stent is composed of nitinol, an extremely flexible, yet strong alloy, that gives the stent shape memory. The MAVErIC II study will also evaluate the efficacy of the Exponent stent system used in conjunction with the GuardWire device. The Medtronic Exponent stent system is designed to push the atherosclerotic material back against the carotid artery wall, and the GuardWire device is designed to capture dislodged particles The Exponent stent system is an investigational device and is not available for commercial distribution in the United States or in Europe. The GuardWire system, the first and only FDA-cleared embolic protection device, has been available for use in U.S. markets since June 2001 for treating diseased saphenous vein grafts (SVGs). Medtronic is currently evaluating the use of the GuardWire system during a catheter-based intervention to treat an acute myocardial infarction. Medtronic Announces European Launch of New Driver Coronary Stent Using Modular Technology and Cobalt-based Alloy Six-Month Preliminary Angiographic Data from U.S. Registry Trial Suggest Promising Clinical Outcomes for Patients Medtronic, Inc. announced the European launch of its new Driver Coronary Stent System, for which the company recently received CE (Conformite europeene) Mark approval. The first and only modular stent to be composed of a cobalt-based alloy, the Driver stent is approved for treating de novo and restenotic lesions in coronary vessels with a diameter of 3.0-4.5mm. Peer-reviewed literature suggests that thinner struts may help prevent the renarrowing of vessels following an intervention.1 The Driver stent’s alloy surpasses the limitations of stainless steel by making possible very strong, ultra-thin struts that offer flexibility and vessel support. The company also announced preliminary six-month angiographic results for a 101-patient subset of its U.S. Driver De Novo and Restenotic Registry Trial, which demonstrated a low 3.0 percent Target Lesion Revascularization (TLR) rate in patients with diseased coronary arteries with a diameter of 3.0-4.0mm. The new Micro-Driver coronary stent, specifically designed for small vessels or those with a diameter of 2.25-2.75mm, also received CE Mark approval, and will launch in Europe in the first half of 2003. The Driver coronary stent is available in all countries in the European Union in sizes that are 3.0, 3.5 and 4.0mm in diameter and 9, 12, 15, 18, 24 and 30mm in length. Additional sizes, including the Micro-Driver coronary stent, will be launched in Europe in the first half of 2003. A U.S. launch of the Driver Coronary Stent System is targeted for the second half of 2003. 1Circulation, June 2001. Siemens Provides Monitoring Solution to New Heart Hospital The Electromedical Systems Division of Siemens Medical Solutions announced that it has sold Oklahoma Heart Hospital, a new facility in Oklahoma City, an INFINITY Patient Monitoring system worth over $2 million. The system, which combines patient monitors with an integrated information network, completes a larger installation of Siemens solutions in the hospital, expected to open this summer. The INFINITY Patient Monitoring System offers the PICK AND GO concept, designed to move with a patient throughout the hospital and to expand or contract on demand for varying patient types, acuity levels, and care environments. With this device, there is no need to change monitors and cables every time a patient is moved, eliminating the need for transport monitors and increasing the time clinicians can spend with their patients. Being built through a partnership between Oklahoma Cardiovascular Associates and Mercy Health Center, Oklahoma Heart Hospital will be the only dedicated heart hospital in the state. Because all of our patients will have some form of cardiovascular disease, they must be constantly monitored, as even a slight change in their vital signs can signal a much larger problem, said Mike Schroyer, president, Oklahoma Heart Hospital. The INFINITY Patient Monitoring System’s technology allows monitors to go with patients as they move around the hospital This will be a great benefit to us, as all patient information will be recorded and there will be absolutely no time when patients are not monitored. Cleveland Clinic’s Dr. Yadav Named in AHA Top 10 Research 2002 Study is First to Demonstrate Intervention Superior to Surgery in Cardiovascular Medicine The American Heart Association has issued its top 10 research advances for 2002. Named among them is the project led by Jay Yadav, MD, Cardiovascular Medicine, which studied the treatment of carotid artery blockage. This is the second year in a row Cleveland Clinic Heart Center research has made the AHA top 10 list. Last year, Cardiovascular Medicine Chairman Eric Topol, MD’s research into the genetic basis of familial early-onset heart disease was cited. Dr. Yadav’s study made history because it was the first time that an interventional procedure has been shown to be superior and not just equal to surgery in cardiovascular medicine. Here is a description of the study from the American Heart Association’s 2002 Scientific Sessions: A refined angioplasty technique may offer an alternative to carotid endarterectomy. Patients at high risk of stroke due to fatty blockages in the arteries leading to the brain benefited from a refined angioplasty procedure, researchers reported at the American Heart Association’s Scientific Sessions 2002. The refinement: a small filter that catches loose bits of plaque before they migrate to the brain and cause a stroke. [Note: This filter was developed by Dr. Yadav.] Cleveland Clinic researchers studied 307 patients with clogged carotid arteries. About half had a standard surgical procedure called carotid endarterectomy. The others underwent the refined non-surgical angioplasty technique. At 30 days after their procedure, the rate of death, heart attack and stroke was about 50% less in those who underwent refined angioplasty (5.8%) than in those who underwent carotid endarterectomy (12.6%). To test the filter approach, the researchers employed Angioguard, made by Johnson & Johnson, which funded the study. During the angioplasty and stent placement in the artery, the filter, made of nickel and titanium, is opened, much like an umbrella, beyond the area being treated. When the procedure is over and it closes, it traps the debris inside. The filter is then covered with a tiny sheath and removed from the artery. UIC Cardiologists Use 3-D Imaging To Help Repair Congenital Defects Physicians at the University of Illinois Medical Center at Chicago are the first in the country to use Electron Beam Tomography (EBT) technology to help treat patients with congenital heart disease who undergo cardiovascular interventions in the catheterization laboratory. While more than 150 centers worldwide provide EBT scanning to detect coronary artery calcification, lung cancer and other diseases, no other center has used this technology as a diagnostic tool during cardiac catheterization. The EBT scanner provides a great advantage in repairing major defects, says Dr. Carlos Ruiz, chief of pediatric cardiology at UIC. Our unique use of this existing equipment offers patients the most accurate, safe and non-invasive imaging method for guiding transcatheter cardiovascular interventions and evaluating the final result. Unlike conventional CT and MRI scanners, the Electron Beam Tomography scanner acquires images much faster and with significantly less radiation exposure, making it possible to capture clear pictures of the beating heart. Electron Beam Tomography, also referred to as ultra-fast CT, has been commonly used as a preventative tool and is a reliable non-invasive test for the early detection of coronary artery disease. The scanner uses high-resolution, 3-D software that provides instantaneous images. The images can then be rotated in any direction to obtain precise anatomic information, including a virtual reality-like view of the inner vessels that is otherwise unobtainable. Interventional cardiologists at UIC have used 3-D high-speed imaging to evaluate and treat more than 70 patients with congenital heart defects, ranging in age from 1 day old to 74 years old. St. Jude Medical Announces FDA Approval of New Labeling For 6F Angio-Seal STS Platform New Clinical Data Demonstrates Safety of Reduced Time to Patient Ambulation and Discharge St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval of new labeling for its 6F Angio-Seal STS vascular closure devices. The new labeling follows completion of an Investigational Device Exemption (IDE) study, which demonstrates how the Angio-Seal STS device significantly reduces the time to patient ambulation and discharge following diagnostic procedures. The IDE study conducted by St. Jude Medical demonstrated how the 6F Angio-Seal STS device can significantly reduce the time to patient ambulation following diagnostic angiography procedures, showing 35 percent of patients ambulating in less than five minutes and the majority ambulating within 10 minutes. The study also resulted in no major complications. The FDA-approved new labeling for only St. Jude Medical products includes clinical data that shows many patients can be safely ambulated in less than 20 minutes and discharged one hour post-ambulation following diagnostic procedures. Hospitals operate within a strictly defined set of protocols determining when patients should be safely ambulated and then discharged following a diagnostic angiography procedure. The St. Jude Medical Angio-Seal device offers virtually instantaneous hemostasis, with the ability for early ambulation and discharge times. However, many hospitals have not yet adjusted their clinical pathways to align with the capabilities that the Angio-Seal device provides, requiring additional scientific data that supports changing post-procedural patient protocols. This study provides clinical data which demonstrates the safety of changing those protocols, assisting hospitals in adopting earlier ambulation and discharge practices to fully realize the benefits of the technology. By changing clinical pathways to reflect the Angio-Seal STS clinical data, hospitals also have the potential to expand their lab utilization beyond its current capacity. The full details of the labeling change, including precautions, will be printed in future "Instructions for Use," which are included in the product package. The Company anticipates publication of the final results of the IDE clinical in the near future. Merit Medical Introduces New Safety Procedural Kit for Vascular Access Merit Medical Systems Inc. a manufacturer and marketer of proprietary disposable products used in cardiology and radiology procedures, announced the introduction of its new Access Safety Kit (ASK Merit) that will be used for vascular access just prior to a diagnostic or interventional procedure. The devices in the kit help reduce the cost and risk of needlesticks and other sharps injuries associated with gaining vascular access in cardiology and radiology procedures, primarily involving angioplasty and stenting. The new ASK safety kit is designed to help clinicians comply with the Needlestick Safety and Prevention Act (H.R. 5178). The ASK Merit safety kit incorporates new shielded technology, including four shielded needles and a shielded scalpel. The angiography shielded needle is Merit’s own Majestik Shielded Needle, which is used to gain access to a patient's artery in order to insert guide wires and catheters. The other three smaller shielded needles are used to anesthetize the tissue at the puncture site. These needles, as well as the safety scalpel, are obtained from third party vendors. Study Shows Lower Risk of Impairment of Renal Function Using Visipaque The use of Visipaque, a diagnostic pharmaceutical produced by Amersham plc, significantly reduces the relative risk of developing contrast media-induced impairment of renal function, a serious clinical problem in some patient groups.1 The NEPHRIC study investigated the effects of Visipaque in patients with existing kidney problems and diabetes who were undergoing investigation for cardiovascular disease. It is the first randomized, double-blind study to examine the risk of CM-induced nephropathy in high-risk patients receiving Visipaque versus a low-osmolar non-ionic agent. Patients with existing kidney problems and diabetes are at higher risk of developing further kidney damage from contrast media which are used in medical diagnostic procedures. The NEPHRIC results show that the use of Visipaque significantly reduced this risk, with patients given Visipaque being 11 times less likely to develop kidney damage than those administered a conventional non-ionic contrast medium. The NEPHRIC (Nephrotoxicity in high-risk patients a double blind randomized multicenter study of isosmolar and low-osmolar non-ionic contrast media) is a randomized, double-blind, prospective, multi-center study; it was conducted in 129 diabetic patients with serum creatinine levels of 1.5-3.5 mg/dl who underwent coronary or aorto-femoral angiography. The primary endpoint was the peak in serum creatinine from day 0 to 3. Other endpoints were the number of patients with increased serum creatinine > or = 0.5 and > or = 1.0 mg/dl, and the change from day 0 to 7. Adverse events associated with both contrast media were also recorded. (1) Nephrotoxic Effects in High-Risk Patients Undergoing Angiography. Aspelin,P et al. N Engl J Med 2003;348:491-9. Doctors Probe Miscarriage Link to Heart Risk Women who have a history of miscarriages could have a higher chance of suffering and dying from heart disease later in life, scientists said. Recurrent miscarriage was only one of many risk factors that may be involved in the development of heart disease. This is just one aspect of a whole series of things that should be taken into account when assessing cardiovascular risk. There is certainly justification for further studies, Professor Gordon Smith, of The Rosie Hospital in Cambridge, England, told Reuters. My feeling is that miscarriage and heart disease are common manifestations of some underlying problem. Smith and his colleagues analyzed Scottish maternity records of 130,000 women who had babies between 1981 and 1985 and hospital admissions and deaths from heart disease 15 to 20 years later. They found that women who had one miscarriage before a live birth had about a 50 percent higher risk of heart disease later in life, according to Smith's research. If there had been three or more miscarriages prior to the first successful pregnancy the risk is increased by approximately two and a half times, said Smith. The scientists are not suggesting that the women had heart disease during pregnancy but that whatever predisposes them to heart disease also increases they odds of having a miscarriage and complications in pregnancy. Smith believes there is a biologically plausible link to explain the results and suggested that clotting disorders and anti-cardiolipin antibodies, which are associated with deep vein thrombosis, could be involved.

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