Clinical and Industry News

Vascular Solutions Launches the Guardian® II Hemostasis Valve

Vascular Solutions, Inc. announces the availability of the Guardian® II Hemostasis Valve. Unlike conventional rotating hemostasis valves, the Guardian II has an ergonomic click-open and click-close design to provide protection during interventions and separation of multiple guidewires and other devices used in the catheterization procedure. A new and improved design of the original Guardian, the Guardian II has a shorter overall length, clear rotating components, and intuitive symbols added to the device. Manufactured by Zerusa Limited of Galway, Ireland, the Guardian II hemostasis valve uses proprietary seal technology to provide independent movement of, and a complete seal around, each device. With its ergonomic click-open and click-close design, the Guardian II fits comfortably in the hand and allows for easy one-hand operation. Like the original Guardian, the Guardian II has an 8F compatible lumen to allow delivery of multiple therapeutic devices and a secure device lock to prevent unwanted wire or device movement. The Guardian hemostasis valve is available in the United States exclusively through Vascular Solutions, Inc. For more information, visit www. vascularsolutions.com. _______________

New EkoSonic® Mach4e Launched at VEITHsymposium™ in New York No Limits to Treating Thrombus

EKOS Corporation has launched the EkoSonic™ Mach4e with Rapid Pulse Modulation (RPM) for the dissolution of vascular blood clots at the 36th Annual VEITHsymposium in New York. Robert W. Hubert, President and CEO of EKOS Corporation said, “For performance, we have achieved even faster removal of arterial and venous clots (accelerating thrombolysis speed by up to 40%1) making it even faster than the Mach4. For simplicity, we have eliminated user inputs which can be safely automated without requiring operator attention.” Providers can use the Mach4e anywhere in the periphery, including: • Veins, arteries, IVC filters and difficult-to-reach places, such as behind valves, exposing clot to a greater drug uptake2 • Thrombus of any size, shape, volume and age3 can be treated with less lab time • Uses 50-70% less lytic drug3, no thrombus fracture or breakage4 reducing the risk of distal embolism • No hemolysis4, no damage to valves4 or vascular wall • A higher level of vessel patency. Removes the thrombus more completely, possibly reducing the risk of post-thrombotic syndrome (PTS) The EkoSonic System is FDA-cleared for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. It is currently used to treat patients with peripheral arterial occlusions (PAO) and deep vein thrombosis (DVT) and additional applications are being investigated. EKOS is currently participating in the ATTRACT trial, which will evaluate the long‐term benefits of using ultrasound catheter‐directed thrombolysis for removal of clot. Visit www.ekoscorp.com References 1. EKOS in vitro data on file 2. Francis CW, Blinc A, Lee S, Cox C. Ultrasound Accelerates Transport of Recombinant Tissue Plasminogen Activator into Clots. Ultrasound Med Biol 1995;21(3):419-424. 3. Parikh S, Motarjeme A, McNamara T, et al. Ultrasound‐Accelerated Thrombolysis for the Treatment of Deep Vein Thrombosis: Initial Clinical Experience. J Vasc Interv Radiol 2008 Apr;19(4):521-528. 4. Braaten JV, Goss RA, Francis CW. Ultrasound reversibly disaggregates fibrin fibers. Thromb Haemost 1997 Sep;78(3):1063-1068. _________________

Updated Guidelines Include Latest Findings on Treatment of Heart Attack, Coronary Disease

A collaborative, fast-track update to two sets of clinical guidelines calls for community-wide coordination of emergency services so that heart attack patients receive the most effective treatment as quickly as possible. The new document also lays out several new treatment options, not only for patients who are experiencing a heart attack but also for those who undergo angioplasty and stenting. The new guidelines update is a joint effort of the American College of Cardiology (ACC), the American Heart Association (AHA), and the Society for Cardiovascular Angiography and Interventions (SCAI). It simultaneously brings focused updates to two separate clinical guidelines, one on the management of patients with ST-elevation myocardial infarction (STEMI) and the other on percutaneous coronary intervention (PCI). “The focused update is a way of responding quickly to new information that will benefit patients,” said Sidney C. Smith, Jr., MD, a professor of medicine and director of the Center for Cardiovascular Science and Medicine at the University of North Carolina at Chapel Hill and chair of the writing group. “We were able to look over a year of major studies and incorporate the most valuable findings into the existing guidelines.” One of the most important new recommendations is for each community to develop an organized system of emergency care for patients who are having a heart attack, modeled after the AHA’s Mission: Lifeline initiative and the ACC’s Door-to-Balloon (D2B) campaign. This plan would include protocols for identifying heart attack patients even before they reach the hospital and directing ambulances to medical centers capable of rapidly performing PCI to open the blocked coronary artery. The plan would also include protocols for managing heart attack patients who initially arrive at hospitals not equipped to perform PCI, including arrangements for rapid transfer to a PCI center, whenever possible. In addition, the guidelines address the management of patients who initially go to a non-PCI hospital and cannot be transferred quickly. These patients should be treated with thrombolytics, according to the guidelines. Afterward, if patients are judged to be high-risk, it is reasonable to transfer them to a PCI center without delay, rather than waiting to observe whether the thrombolytics are successful, as is common practice today. Another major change in the guidelines is greater acceptance of stenting for the treatment of the left main coronary artery. “There is mounting evidence that stenting of the left main coronary artery, under certain circumstances, does carry a reasonably good outcome,” said Spencer B. King, III, MD, president of the Saint Joseph’s Heart and Vascular Institute and a professor of medicine emeritus at Emory University School of Medicine in Atlanta and co-chair of the writing group. “Now stenting might be considered, based on the specific anatomy of the coronary arteries and the risk profile of the patient.” The guidelines update incorporates several additional changes, including the following: • Use of fractional flow reserve. • Use of aspiration thrombectomy. • Use of prasugrel, an alternative to clopidogrel for patients treated with PCI. • Recommendations for use of a variety of blood thinners and anti-clotting medications before, during or after PCI. • Broader recommendations on types of contrast media for patients with chronic kidney disease. The new focused guidelines update will be published in the December 1, 2009, issue of Journal of the American College of Cardiology, the December 1, 2009 issue of Circulation: Journal of the American Heart Association, and online November 18, 2009, in Catheterization and Cardiovascular Interventions. It is also available on the Web sites of the American College of Cardiology (www.acc.org), the American Heart Association (my.americanheart.org), and the Society for Cardiovascular Angiography and Interventions (www.scai.org). _________________

Toshiba Introduces the Infinix VF-i/BP Vascular X-Ray System With Large and Mid-Sized Flat Panel Detectors

New Infinix System Offers Universal Bi-Plane Configuration Toshiba America Medical Systems, Inc. introduced the all new Infinix™ VF-i/BP with large and mid-sized flat panel detectors. The large and mid-sized flat panel detectors provide clinicians with the ability to obtain critical variations in angle combinations while providing the necessary anatomical coverage, creating a bi-plane vascular x-ray system for any clinical application. The new Infinix VF-i/BP features Toshiba’s new mid-sized 12” x 12” flat panel detector on the lateral plane, combined with the large 12” x 16” flat panel detector on the frontal plane to allow clinicians additional and steeper angle combinations. The mid-sized, high-resolution 12” x 12” flat panel detector enables physicians to conduct a variety of bi-plane applications, allowing for steep, compound bi-plane projections. The long field-of-view of the large panel makes it ideal for carotid interventions because it provides optimal coverage from proximal guiding catheter to distal safety device during carotid angioplasties. The large 12” x 16” flat panel detector on the five-axis frontal plane can be utilized as a single plane in the imaging of large anatomical regions such as chest and abdomen, as well as peripherals. Developed based on the popular Infinix-i series platform, the Infinix VF-i/BP is a floor-mounted frontal/ceiling-mounted lateral bi-plane system featuring multi-axis positioners. ________________

French Physicians to Conduct 2000-Patient Study of Catania Coronary Stent

Physicians at more than 40 centers in France have joined a study of the Catania™ Coronary Stent with NanoThin Polyzene®-F manufactured by CeloNova BioSciences. With Professor Emmanuel Teiger and Doctor Paul Barragan as co-Principal Investigators, the researchers announced the Assessment of The Latest Non-Thrombogenic Angioplasty (ATLANTA-France) stent study. Each center began to enroll 50 patients in early November. The study will evaluate the short-, mid- and long-term safety and efficacy of the Catania coronary stent for the treatment of up to three de novo native coronary artery lesions in a real word setting. Thomas A. Gordy, President and Chief Executive Officer of CeloNova BioSciences, said, “Physicians throughout France have already used the Catania stent, but this registry will increase participation over broad spectrum of new facilities to this stent without drugs on the surface and for which patient do not have to take long-term dual antiplatelet therapy.” The Catania stent is CE marked and available throughout the European Union, in the Middle East, and Northern Africa. The stent, treated with CeloNova’s anti-thrombotic and bacterial resistant Polyzene-F surface, is available in 60 sizes. For more information, please visit www.celonova.com _______________

Merit Medical Announces 510(k) Clearance for the Merit Laureate™ Hydrophilic Guide Wire

Merit Medical Systems, Inc. a manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and gastroenterology, announced that it has received 510(k) clearance from the FDA for the Merit Laureate™ hydrophilic guide wire. The Merit Laureate guide wire is fabricated from a core nitinol wire, covered with a urethane jacket and coated with a proprietary process that produces a slippery surface. Features of the wire, including torquability and pushability, allow passage through tortuous anatomy. The project, code-named “The Irish Project,” is scheduled for worldwide release in January 2010. ________________

ACC/AHA Release Revised Guidelines for the Prophylactic Use of Beta Blockers to Minimize Cardiac Risk Around Time of (Noncardiac) Surgery

Cardiac complications around the time of noncardiac surgery are relatively common and can be serious. The American College of Cardiology (ACC) and the American Heart Association (AHA) released a Focused Update to the Practice Guidelines based on new clinical trial data that summarizes and sheds light on the risks and benefits of using beta blockers to reduce cardiac events during noncardiac surgeries, and provides specific recommendations about which patients will likely benefit and in which patients there is not enough evidence to recommend their use. “Any surgery, particularly a high-risk procedure, is a stress on the heart, especially for those with underlying circulation problems or other cardiovascular risk factors,” says Kirsten E. Fleischmann, MD, MPH, chair of the 2009 writing group that reviewed the latest evidence on the perioperative use of beta blockers. “In general, the higher the risk from a cardiovascular standpoint, the more likely a patient will benefit from beta blockers. However, newer data from the POISE [Perioperative Ischemic Evaluation] trial suggest that starting higher doses of beta blockers acutely on the day of surgery is associated with risk as well, so careful patient selection, dose adjustment and monitoring throughout the perioperative period is key.” More than 30 million noncardiac surgeries are performed in the United States each year. Cardiac problems around the time of surgery are a major cause of complications and death in these patients, prolonging hospitalizations and increasing costs. The recommendation to continue beta blockers perioperatively in those patients who are already receiving them remains current since the initial 2007 guidelines were published. The workgroup advises beta blockers are reasonable to consider in: • Patients at high risk for heart attacks or other cardiac complications because of abnormal stress test results or known coronary artery disease who undergo vascular surgery • High risk patients undergoing intermediate risk surgery or in those with multiple risk factors for complications (e.g., diabetes, a history of heart failure, significant kidney disease) who undergo vascular surgery However, authors caution that when beta blockers are started in patients not yet taking them, the medication should be initiated well before the procedure and titrated up as blood pressure and heart rate allow. “We recommend beta blockers be started well in advance of surgery and not at higher doses right off the bat,” says Dr. Fleischmann. “These updated guidelines are intended to provide guidance for the appropriate use of beta blockers to help reduce the risk of cardiac complications. Physicians must be vigilant in assessing patients’ cardiac risk and weighing this against potential side effects of the therapy.” According to the authors, the usefulness of beta blockers remains uncertain in lower-risk patients or in those undergoing lower-risk surgeries (e.g., percutaneous or endovascular procedures), and requires careful consideration of the risks and benefits. The guidelines do not advocate for routine administration of beta blockers, particularly in higher fixed-dose regimens, begun on the day of surgery based on data from the POISE study. While there was a reduction in perioperative myocardial infarction and primary cardiac events among study participants, the use of beta blockers was also associated with higher rates of stroke and overall mortality. Beta blockers should not be used when contraindications exist. This ACCF/AHA update was developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, and Society for Vascular Surgery. Full text of the Focused Update is published in the November 24, 2009, issue of the Journal of the American College of Cardiology and the November 24, 2009, Circulation, and will be posted on the ACC (www.acc.org) and AHA (www.americanheart.org) websites. Dr. Fleischmann reports no conflicts of interest. ______________

Heart Attacks Become More Common but Less Often Fatal in Women

Heart attacks appear to have become more common in middle-aged women over the past two decades, but all women and especially those younger than 55 have recently experienced a greater increase than men in their chances of survival following such a heart event, according to two reports in the Archives of Internal Medicine, one of the JAMA/Archives journals. Middle-aged women have historically had a lower overall risk of heart events and stroke than men of a similar age. However, a recent report showing higher stroke rates among women than men in a sample representative of the U.S. population appeared to reveal a new phenomenon and raised the question of whether heart disease or heart attack were also becoming more prevalent among women. Amytis Towfighi, MD, of the University of Southern California, Los Angeles, and colleagues analyzed data from U.S. adults age 35 to 54 who participated in the National Health and Nutrition Examination Surveys (nationally representative surveys conducted by the government) during 1988 to 1994 (4,326 participants) and 1999 to 2004 (4,075 participants). The researchers assessed how often men and women had heart attacks and also compared their Framingham coronary risk score, a measurement of heart disease risk over 10 years that includes factors such as age, cholesterol levels, blood pressure and smoking history. In both study periods, men age 35 to 54 years had more heart attacks than women in the same age group. However, the gap narrowed in more recent years as heart attacks decreased in prevalence among men and increased in prevalence among women (2.5 percent of men and 0.7 percent of women reported a history of heart attack in 1988-1994, whereas 2.2 percent of men and 1 percent of women did so in 1999-2004). Between the two time periods, the average Framingham coronary risk score showed an improving trend among men but decreased among women. In male participants, total cholesterol levels remained stable, high-density lipoprotein (HDL or “good” cholesterol) levels and systolic (top number) blood pressure levels improved and smoking levels declined. The only risk factor that improved among women was HDL levels. Diabetes prevalence increased among both men and women, likely due to insulin resistance and the obesity epidemic in both sexes. “Although men in their midlife years continue to have a higher prevalence of myocardial infarction and a higher 10-year risk of hard coronary heart disease than women of similar age, our study suggests that the risk is increasing in women, while decreasing in men,” the authors write. “Therefore, intensification of efforts at screening for and treating vascular risk factors in women in their midlife years may be warranted.” In another report, Viola Vaccarino, MD, PhD, of Emory University School of Medicine, Atlanta, and colleagues investigated trends in the rate of in-hospital deaths following heart attack from June 1, 1994, through Dec. 31, 2006. Data were collected from 916,380 patients through the National Registry of Myocardial Infarction. In-hospital death rates decreased among all patients between 1994 and 2006, but decreased more markedly in women than in men. The reduced risk of death was largest in women younger than 55 years (a 52.9 percent reduction) and lowest in men of the same age (33.3 percent). The absolute decrease in the risk of death among patients younger than 55 was three times larger in women (2.7 percent) than men (0.9 percent). “A large part (93 percent) of this sharper decrease in mortality of younger women compared with men in recent years was because the risk status of women on admission improved compared with that of men,” the authors write. “Such improvement may be due to better recognition and management of coronary heart disease and its risk factors in women before the acute myocardial infarction event, as suggested by the narrowing sex difference in previous revascularization.” Source: Arch Intern Med. 2009;169[19]: 1762-1766 and 1767-1774. _______________

Abbott Announces Positive Three-Year Data on Its Fully Bioabsorbable Stent Technology, Initiates Large-Scale International Trial

New ABSORB EXTEND Trial to Study Performance of Bioabsorbable Device in Approximately 1,000 Patients Abbott announced three-year data from the first 30 patients in the first phase of the ABSORB clinical trial, demonstrating that its fully bioabsorbable drug-eluting coronary stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries. Patients in this first phase of the ABSORB trial experienced no stent thrombosis out to three years and no new major adverse cardiac events (MACE) between six months and three years (3.6 percent at three years). These results were presented at the 2009 American Heart Association’s Scientific Sessions. To build upon the results of the ABSORB trial, Abbott is initiating a large-scale trial called ABSORB EXTEND, which will enroll approximately 1,000 patients from up to 100 centers in Europe, Asia Pacific, Canada and Latin America. ABSORB EXTEND is a single-arm study designed to further evaluate the performance of Abbott’s proprietary fully bioabsorbable stent technology. The study will enroll patients with more complex coronary artery disease and is slated to begin enrolling before the end of the year. “Abbott’s bioabsorbable stent has the potential to be a major breakthrough for coronary artery disease patients. The data show that patients continue to do well three years after treatment with the bioabsorbable coronary stent,” said Patrick W. Serruys, MD, PhD, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. “The strong results confirm my belief that bioabsorbable technology is the next revolution in interventional cardiology.” Abbott also announced that patient enrollment is complete for the second phase of the ABSORB trial. The second phase of the ABSORB clinical trial enrolled 101 additional patients from 12 centers in Europe, Australia and New Zealand, and incorporated device enhancements designed to improve deliverability and vessel support. Abbott is the only company with three-year clinical data evaluating the safety and performance of a fully bioabsorbable drug-eluting coronary stent. Abbott’s bioabsorbable everolimus-eluting coronary scaffold is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as absorbable sutures. The ABSORB trial is a prospective, non-randomized (open label), two-phase study designed to enroll approximately 130 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety —MACE and stent thrombosis rates — at 30 days; six, nine, 12 and 18 months; and two years, with additional annual clinical follow up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug-eluting stent, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six months, one year and two years. Abbott’s bioabsorbable drug-eluting coronary device delivers everolimus, a drug that inhibits tissue proliferation. Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug-eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties. _______________

Acute Heart Attack Patients Receiving High Ionizing Radiation Dose

Acute heart attack patients received an average total dose of ionizing radiation equal to 725 chest X-rays from medical tests during their hospital stay, according to research presented at the American Heart Association’s Scientific Sessions 2009. In the first large study to examine total radiation dosage in heart attack patients, researchers found those admitted to academic hospitals had a cumulative effective radiation dose of 14.5 millisieverts (mSv) — about one-third the annual maximum accumulation permitted for workers in nuclear power plants and other ionizing radiation environments. “It’s potentially a new way to consider radiation exposure and safety,” said Prashant Kaul, MD, lead author of the study and a fellow in cardiovascular medicine at Duke University Medical Center in Durham, NC. “We think physicians should not only have a greater awareness of dose accumulation from the tests they are ordering, but also understand the testing patterns they use for common diagnoses.” Total short term exposure likely counts, he said. A person’s lifetime exposure to ionizing radiation can potentially increase the risk of cancer. However, risk estimates vary for developing malignancies at specific exposure levels. Physicians perform several billion imaging studies annually worldwide, about one-third of them in cardiovascular patients. The collective dose received annually from ionizing radiation medical tests increased an estimated 700 percent between 1980 and 2006, according to the American Heart Association. Kaul urged increased efforts to better determine the appropriate use of various radiation-based tests when assessing and treating heart attack patients. “We should not withhold necessary, appropriate tests that involve ionizing radiation — they provide very important information,” Kaul said. “What we should do is evaluate and understand the clinical indications for tests that involve ionizing radiation. We need to be sure they are being done appropriately.” Researchers analyzed data from 64,074 patients — 23,394 women and 40,680 men — treated for acute heart attack between 2006 and the second quarter of 2009 at 49 academic hospitals throughout the United States that participate in the University Health System Consortium and subscribe to their resource manager database. Among the study’s findings: • Patients received 276,651 tests that used ionizing radiation, an average of seven per patient. • Patients averaged a total accumulation of 14.52 mSv during their hospital stay. • Among the nine types of tests analyzed, 83 percent of all patients received chest X-rays; 77 percent had catheter procedures; 15 percent underwent body computed tomography (CT) scans; and 12 percent had a head CT. • Between 1 percent and 6 percent of patients had three other nuclear imaging tests and chest CT. Physicians tend to focus on the radiation dose of each procedure rather than the cumulative dose a patient will receive, he said. “This makes the risk seem smaller to patients than it actually is. The risk at an individual level is small with one test, but with multiple tests the risk likely increases. Additionally, a small individual risk applied to a growing and aging population could potentially represent a future public health problem, especially if the trend continues to be increased use of cardiac imaging tests involving ionizing radiation.” The study has several limitations. For one, the researchers used estimates of typical effective radiation doses from several sources, including the American Heart Association Committee on Cardiac Imaging. Thus, their reported cumulative and radiation dose per patient is an estimate rather than actual measurement. Moreover, the researchers selected nine tests used in assessing heart attacks for their study, but physicians may also use others.

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