Clinical and Industry News

FDA Approves Cordis’ CYPHER Sirolimus-eluting Coronary Stent Cordis Corporation, a Johnson & Johnson company, has received approval from the U.S. Food and Drug Administration (FDA) to market its CYPHER Sirolimus-eluting Coronary Stent, making it the first U.S.-approved combination drug device intended to help reduce restenosis of a treated coronary artery. Cordis is very pleased to bring this remarkable and innovative treatment to patients, hospitals and interventional cardiologists, said Johnson & Johnson Company Group Chairman Robert Croce, who has worldwide management responsibility for Cordis Corporation. Clinical evidence and experience with more than 50,000 patients treated to date in nearly 60 countries, suggests the CYPHER Stent represents the beginning of a new era in interventional cardiology an era in which the combination of drugs and devices substantially improves patient outcomes. Jeffrey W. Moses, M.D., of Lenox Hill Hospital, New York, a principal investigator in the U.S. clinical trials for the new device said: The CYPHER Stent clinical trials set a new standard in coronary artery stent investigation. No other stent in this category has been studied so extensively in such a wide range of high-risk patients with difficult-to-treat lesions. Clinical evidence is clear that cardiologists can use this new stent with confidence. The FDA approved the CYPHER Stent under an expedited review for use in native coronary arteries with reference diameters of 2.5 mm to 3.5 mm and lengths in 8, 13, 18, 23, 28 and 33 mm. The CYPHER Stent was first introduced by Cordis in April 2002, and is now available throughout Europe, the Middle East, Canada, Asia-Pacific and Latin America. Combined with the pharmaceutical agent sirolimus*, the CYPHER Stent is placed into a human coronary artery to prevent restenosis (reblocked arteries). Sirolimus, marketed as Rapamune® by Wyeth Pharmaceuticals, is a commercially available drug developed from a naturally occurring substance first isolated from soil samples in Easter Island in the South Pacific. Mr. Croce said, We are seeing solid clinical results, out to three years in our initial pilot study. The CYPHER Stent is the only drug-eluting coronary artery stent whose performance is supported by two large-scale, randomized, double-blind, controlled clinical trials. These trials, involving approximately 1,400 patients, continue to support the long-term unprecedented results for the CYPHER Stent, said Dr. Moses. Data from the two-year follow-up on the European RAVEL trial and the one-year follow-up on the landmark U.S. SIRIUS trial were presented at the American College of Cardiology's 52nd Scientific Session in March. The CYPHER Stent data showed sustained reduction in the incidence of restenosis by more than 90% as compared to a conventional bare metal stent, with a greater than 95% chance that patients can avoid retreatment. The results were achieved in a broad range of patients, including those with complex lesions and at high risk for reblockage. Recognizing the medical value of drug-eluting stents, the Centers for Medicare and Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services, moved forward in August 2002 with approval of incremental reimbursement for the new medical device, effective April 1, 2003. This new policy provides significant incremental reimbursement over and above the current bare metal stent reimbursement levels. Cordis is also actively engaged with Medicaid and private insurance payers to grant coverage and incremental reimbursement for drug-eluting stents. A recent independent economic analysis of the SIRIUS trial performed by David J. Cohen, M.D., Harvard Clinical Research Institute, showed that the CYPHER Stent was cost-effective at one-year post treatment and will enable payers to recoup virtually all costs associated with the CYPHER Stent within 12 months. The analysis looked at actual hospital in-patient and outpatient cost data, beginning with the period of initial hospitalization and ending one-year following stent implantation. For every 100 patients treated with the CYPHER Stent, there were 19 fewer revascularizations and 25 fewer hospital admissions than with the conventional stent, translating into substantial post-treatment healthcare savings. Physicians or professionals inquiring about the CYPHER Stent can either visit www.CYPHERUSA.com or call 1-800-781-0282. St. Jude Medical Announces FDA Approval of Isoflex S Lead and First Implant of Isoflex P Lead, New Bradycardia Pacing Leads The U.S. FDA has approved the St. Jude Medical, Inc. IsoFlex® S (silicone) pacing lead and the first implant of the IsoFlex® P (polyurethane) pacing lead took place under an FDA investigational device exemption (IDE) study. Paul K. Safer, MD, FACS, performed the first implant of the St.Jude Medical IsoFlex® P lead at Middlesex Hospital in Middletown, Connecticut. The lead was implanted with a St. Jude Medical Affinity® SR Model 5130 pacemaker in an 81-year-old man. The implant proceeded as expected and the patient is doing fine. Dr. Safer said, The thin profile and smooth sliding characteristics made cephalic vein implantation very easy. Dr. Safer previously performed the first U.S. implant of the IsoFlex® S lead. The St. Jude Medical IsoFlex® P lead’s reduced diameter allows it to be threaded through a 7 French (2.32 mm) introducer sheath. Both the IsoFlex® S and IsoFlex® P pacing leads are manufactured in straight and J shapes, allowing for ventricular and atrial use, respectively. The leads are also available in bipolar or unipolar configurations. St. Jude Medical plans an immediate U.S. market release of the IsoFlex® S lead. The device received European CE Marking in Sept. 2002 and has been available in all countries of the European Union since early 2003. The IsoFlex® P lead continues to be evaluated as part of a St. Jude Medical clinical study. FDA approval is expected later this year. FDA Panel Unanimously Approves Cook’s Zenith® AAA Endovascular Graft By a vote of eight to zero, the Zenith® AAA Endovascular Graft System, a third-generation stent-graft system for the endovascular treatment of abdominal aortic aneurysm (AAA) from Cook® Incorporated, received unanimous approval from the U.S. FDA’s Public Advisory Circulatory System Devices Panel. The panel added a number of conditions to its approval, including the exclusion of isolated iliac aneurysms from the indications for use and the establishment of five-year follow-up surveillance on the patients included in Cook’s U.S. pivotal trial of the device. Developed jointly by Cook companies in the U.S., Europe and Australia, the Zenith system has been clinically shown to lower morbidity rates, reduce recovery time and improve quality of life for patients undergoing endovascular AAA repair compared to open surgical procedures. Testifying during the public comment period of the hearing was former U.S. Senator Bob Dole, who was treated with a Zenith endovascular graft when his abdominal aortic aneurysm was discovered in June 2001. I’m not here today to endorse a specific product, I’m just here to tell my story and I’m happy to be here today, said Senator Dole, whose own father died of an aortic aneurysm. Study Shows that Cardiac Resynchronization Therapy Reverses Progression of Heart Failure Cardiac Resynchronization Therapy Leads to Reverse Remodeling of the Left Ventricle, Improving Cardiac Efficiency and Quality of Life When it comes to patients with congestive heart failure and the ability of their hearts to pump blood more efficiently, smaller is better. Patients in a large clinical study who received cardiac resynchronization therapy from pacemaker-like devices developed smaller, stronger hearts, a concept known as reverse remodeling. Heart failure often is associated with hearts that have become enlarged and pump less efficiently, but cardiac resynchronization helps return many of these hearts to a more normal size and pumping efficiency. Based on the experience of heart failure patients who received this therapy from the Medtronic InSync® system, their enlarged hearts had shrunk by more than 10 percent compared to patients who received heart failure drug therapy alone. This shrinkage was enough to make the difference between extreme fatigue felt by many patients and their ability to accomplish everyday activities. Because the smaller, trimmer hearts pumped blood more efficiently throughout the body, most patients in the treatment group exercised more than those in the control group and reported an improvement in quality of life. The results were reported by researchers Dr. Martin St. John-Sutton, Professor of Medicine and Director of Cardiac Imaging at the University of Pennsylvania Medical Center in Philadelphia. A 10 percent decrease in heart size is significant, not subtle, said Dr. St. John-Sutton. The implication of reverse remodeling and volume reduction also predicts a decrease in adverse cardiovascular events over longer-term follow up. The bottom line is that as the heart gets smaller, its function gets better and these patients feel better. Doppler echocardiograms were obtained from 323 patients enrolled in the landmark MIRACLE study, a large, randomized clinical trial that led to the U. S. FDA approval of the InSync device for cardiac resynchronization therapy (CRT) in August 2001. Patients were measured at baseline, three months and six months. Those randomized to the treatment arm showed significant reductions in left ventricle mass and volume compared to the control group, which did not receive CRT therapy. The left ventricle is the heart's main pumping chamber. Additionally, patients in the cardiac resynchronization group showed substantial improvements in their heart's ejection fraction, as well as significant decreases in mitral valve regurgitation. William Abraham, MD, Professor of Medicine and Chief of the Division of Cardiology at the Ohio State University Heart Center, notes What’s really exciting is that it doesn't appear to be a temporary phenomenon. The benefits are being sustained, over and above what these patients are receiving from standard drug therapy, from follow-up period to follow-up period. CardioNow Expands its Cardiac Imaging Archiving & Sharing Capabilities & Addresses HIPAA Security Issues with Latest Software Release CardioNow, Inc. announced the full market release of its latest software (version 1.5) for electronically capturing, reviewing, analyzing and sharing complete cardiac studies as well as their associated reports via CardioNow’s Internet-based DICOM image archiving and sharing service. Over seventy-five new features and enhancements were incorporated into this latest software release in an effort to enhance a hospital or web-based user’s experience when accessing and sharing cardiac studies. New features include validation and expanded support for all major DICOM cath, echo and IVUS systems, tighter integration of patient reports to insure seamless access and distribution, expanded functionality for two-way DICOM study sharing with outlying referral centers, enhancements to review station and web-based image quality and display, as well as customizable user interface options to meet the distinct needs and improve the workflow for hospital, core lab and trial sponsor users. The new release also provides CardioNow customers with an image and information management system fully compliant with key aspects of HIPAA and HCFA guidelines for privacy and security. Features of the system related to these guidelines include automated off-site backup, extensive data redundancy (up to four instances of the data exist at any given time in separate locations), disaster recovery procedures, user activity auditing and reporting, strong authentication, and the highest level of data encryption currently available. CardioNow also makes use of Verisign Inc.’s Authentication and Authorization services to provide secure and HIPAA/HCFA compliant web-based viewing of streaming images (CardioNow WebView) and secure transmission and sharing of full DICOM image sets (CardioNow WebSend) using any standard PC with Internet access. For additional information regarding CardioNow’s cardiac Image and Information Management Service (IMS), visit www.cardionow.com. GE Medical Systems’ Electron Beam Tomography Exam is Leading Predictor of Heart Attack and Death New Calcium Score Study Completed by St. Francis Hospital, Highlights Results in the Fight Against Heart Disease GE Medical Systems, a unit of General Electric Company, announced results of a cardiac disease study. The St. Francis Hospital Study, conducted by Alan D. Guerci, MD, President & Chief Executive Officer of St. Francis Hospital, Roslyn, NY, concludes that Electron Beam Tomography (EBT) scoring of coronary calcification is more accurate than conventional risk factor assessment in the prediction of coronary disease events. The study, performed using a GE Medical Systems’ EBT scanner, was presented as a late-breaking clinical trial at the American College of Cardiology’s 52nd Annual Scientific Session in Chicago. Dr. Guerci’s study of over 5,000 people is the first ever to follow a general population of non-symptomatic patients, prospectively, over a period of several years. The conclusions of The St. Francis Study provide the most convincing data of EBT’s incremental value over the conventional risk factors used by family physicians and cardiologists. The study demonstrates that people with a calcium score greater than 100 were at 10 times higher risk compared to those scoring less than this threshold. On average the calcium score was four times greater in those suffering an event than in those who did not. Electron Beam Tomography, which provides a simple, non-invasive coronary artery scan for calcification, takes less than 30 seconds with images being captured in a single breath hold. The exam is generally administered to middle-aged men and women having one or more standard risk factors for heart disease. EBT is a technology exclusive to GE Medical Systems. In November 2002, GE introduced the latest advancement in EBT, the new e-Speed system. e-Speed offers physicians a tool to provide a Comprehensive Cardiac exam, including coronary calcification, electron beam angiography, cardiac function, and perfusion. Approval and First Implants of the QuickSite Left Heart Pacing Lead St. Jude Medical, Inc. announced that it has received an Investigational Device Exemption (IDE) from the U. S. FDA authorizing the addition of its QuickSite Left Heart Pacing Lead to the system of devices being studied in its RHYTHM ICD (implantable cardioverter defibrillator) cardiac resynchronization clinical study. The first implants of the QuickSite 1056K lead were performed this week. Dr. Gearoid O'Neill performed the first implant under the U.S. IDE at Mercy General Hospital in Sacramento, California. Dr. Karlheinz Seidl performed the first European implant of the QuickSite lead at The Heart Center in Ludwigshafen, Germany. The implantations proceeded normally and both patients are doing well. The QuickSite 1056K lead is St. Jude Medical’s latest pacing lead designed specifically for placement in the coronary sinus to enable left ventricular pacing in cardiac resynchronization applications. The lead incorporates a number of important new features including: a polyurethane lead body transitioning to a distal silicone tip section for optimal pushability, torque transfer and tip flexibility; an S shaped distal tip conductor designed for improved shape retention and anchoring of the lead at varying locations within the coronary sinus; the ability to position the lead using either a specialized ball-tipped guiding stylet or a guidewire for maximum flexibility in lead placement. Both Dr. O’Neill and Dr. Seidl implanted the QuickSite 1056K lead with an Epic HF ICD, the world’s smallest high-voltage cardiac resynchronization device. The QuickSite 1056K lead is expected to earn CE Marking and enter full European market release later this year. This product will complement the St. Jude Medical Aescula 1055K stylet-driven left heart lead system, which is currently marketed in Europe and is under clinical evaluation in the United States as part of the RHYTHM ICD trial. Preclinical Study of Stents for Treatment of Vulnerable Plaque; Study Evaluates Therapeutic Options for Preventing Heart Attacks Guidant Corporation has announced their findings of a vulnerable plaque study evaluating the use of metallic and drug-eluting stents in a diseased animal model at 28 days. This preclinical study is the first of its kind to evaluate potential therapeutic methods of heart attack prevention by examining favorable responses induced by stent implants in complex lesions exhibiting features of vulnerable plaques. Pedro R. Moreno, MD, of the University of Kentucky, presented the findings of the Guidant-sponsored study at the Association for the Eradication of Heart Attack's 5th Vulnerable Plaque Symposium, held in Chicago, Ill. Our preclinical results indicate that metallic stenting may have the potential to stabilize the thin-capped fibroatheroma features that characterize vulnerable lesions, said Dr. Moreno. However, restenosis rates in high risk, lipid-rich, inflamed plaques deserve further investigation. If these lesions have a higher likelihood of restenosis, drug eluting stents may provide an option for vulnerable plaque resistant to systemic therapy. The study compared the stabilizing features of metallic and drug eluting stents in animals and found that the everolimus eluting stent showed promising results with the lowest risk of restenosis. In September 2002, Guidant announced results of a study utilizing optical coherence tomography (OCT), a new coronary imaging technology that provides resolution 10 times greater than intravascular ultrasound, to examine highly detailed images of complex coronary lesions in patients with coronary artery disease. The Massachusetts General Hospital OCT study found that OCT is able to successfully detect morphological characteristics of coronary lesions that have been associated with heart attack. Duke Children’s Hospital and Health Center Selects Camtronics' Image and Information Management Solution for Pediatric Cardiology Camtronics Medical Systems, Ltd has announced that Duke Children’s Hospital and Health Center has selected VERICIS® for Cardiology for the management of pediatric cardiovascular images and information. The VERICIS solution at Duke will include EchoIMS from VMI Medical, Inc., a subsidiary of Camtronics. Duke Children’s is part of the Duke University Health System, consistently ranked as one of the top 10 health care institutions in the country by U.S. News and World Report. The VERICIS system at Duke Children’s will acquire and store images from the hospital’s cardiac catheterization and echocardiography laboratories, including studies converted from existing modality-specific mini-PACS. The system will give physicians instant network access to integrated cardiovascular patient records throughout the hospital and provide secure Web access to patient images and reports via the Internet. The system integrates VMI Medical’s EchoIMS echocardiography reporting system. The EchoIMS system features a broad array of analytical tools specifically designed for treating patients with congenital heart disease. At the heart of EchoIMS is the fetal and pediatric echo database developed and refined by Children’s Hospital, Boston. This living library of normative data contains indications, examination procedures and diagnostic findings for over 140,000 patient care episodes, going back to 1978. New, Less Invasive Coronary Artery Bypass Procedure Performed Live for Surgeons at Miami Conference Physicians Say Multi-Vessel Small Thoracotomy Patients May Go Home Sooner, Recover Faster A new coronary artery bypass grafting (CABG) procedure made possible by new surgical tools has been successfully performed. The double bypass operation was performed on a 59-year-old man and was broadcast live via satellite to surgeons attending the Cardiothoracic Techniques & Technologies (CTT) conference in Miami. The cardiothoracic surgeon, Dr. Frank Van Praet of Aalst, Belgium, reported that the patient is doing well after undergoing a multi-vessel small thoracotomy (MVST) procedure. The MVST operation, which represents another advance in off-pump heart surgery, is performed via a 2-inch incision while the heart continues to beat. This compares with traditional CABG surgery, which requires a 7-inch cut through the sternum, or breastbone, and the heart is stopped. A number of surgeons who are using Medtronic’s new Starfish NS (non-sternotomy) Heart Positioner to facilitate their MVST procedures report that the new procedure may dramatically reduce the length of hospital stays and recovery time associated with CABG surgery. In the procedure viewed live at the CTT meeting, Dr. Van Praet used the Starfish NS positioner to move and position the beating heart within the closed chest. He also used Intuitive Surgical’s da Vinci Surgical System to access the internal mammary arteries used for bypass grafts. These tools provide access to the heart without fully opening the chest. They enable the surgeon to position the heart, access arteries and create grafts that bypass blockages. The MVST procedure eliminates the need for the median sternotomy incision and the heart-lung machine (cardiopulmonary bypass). Studies indicate that avoiding these two events may decrease the length of hospital stay and accelerate the resumption of normal activities. Dr. Van Praet reports that recovery times associated with MVST procedures are much shorter because patients’ muscles and bones aren’t injured during surgery. GE, Ford, UPS, P&G, Verizon, Others Back Bridges to Excellence, a New Pay-for-Quality Initiative For Physicians Bonuses May Equal 10 Percent Raise for Top Doctors; Effort Aimed to Improve Diabetes, Cardiac Care and Care Management Systems; CMS Lauds Effort A coalition of physicians, health plans, large employers and others have launched the Bridges to Excellence program, an effort to tie physician incentive payments to performance. The effort will initially seek to encourage improvements in three areas: diabetes care, cardiovascular care and patient care management systems. The effort unique in terms of the size of the available incentive payments and the involvement of physicians in its design will also feature incentives for patients to become more involved in their own health care. Partners Community Healthcare, Inc., the Lahey Clinic and the Cincinnati Children’s Hospital Medical Center helped shape the initiative. Public sector support for the pay-for quality approach and the Bridges to Excellence initiative in particular came from the Centers for Medicare & Medicaid Services (CMS), which also participated in developing the program. Under the new program, top-performing doctors could see income gains of up to 10 percent in the form of bonuses paid by participating employers. These physicians will also be highlighted in provider directories, helping employees and their families identify doctors with proven outcomes in treating particular illnesses, or whose patient care and support systems are exemplary. Physicians played an important role in developing the effort and shaping an incentive structure that would appeal to their fellow doctors and spur investments in quality. A lot of physicians would like to invest in information systems to help deliver better care, but insurance payments haven't covered those costs, said Thomas Lee, MD, Chief Medical Officer, Partners Community Healthcare, Inc. Bridges to Excellence changes the financial picture it makes investing in systems to improve care easier. Bridges to Excellence is being introduced in three metro areas that are heavily populated by employees of the companies supporting the program. Diabetes Care Link will be launched in Cincinnati, Ohio, Louisville, Ky. and Boston, Mass. The second, Physician Office Link, will be piloted in Boston. Cardiac Care Link will be introduced late in 2003. Diabetes Care Link (a program modeled on an existing American Diabetes Association/National Committee for Quality Assurance effort) will provide annual bonus payments to physicians who demonstrate good control of their patients with diabetes. An optional patient reward program is available to encourage employees and family members to take an active role in managing their condition. The Physician Office Link program will reward physicians for investing in information systems and care management tools to help them provide more customized and integrated care over time, rather than simply responding to a patient’s symptoms during office visits. The Robert Wood Johnson Foundation is supporting the effort with a $330,000 grant. For more information on the Bridges to Excellence initiative, visit the program’s Web site at www.bridgestoexcellence.org. Latest Market Report on U.S. Cath Lab Facilities Shows Continued Growth in Cath Lab Case Volume Based on their sixth census of all cardiac cath labs in the US, IMV Medical Information Division estimates that patient cases performed in cath labs increased 17% from 1998 to 2001, to 3.84 million. Of these cath lab cases, 91% are cardiac-related with the remaining 9% of cases performed for non-cardiac applications, including carotid, iliac, femoral, run-off, renal and extremity studies. Over half of all sites with cath labs perform some non-cardiac cases, thereby broadening their services to perform peripheral vascular applications. Concurrently, cath labs have increased their ability to electronically store and use their cath lab images digitally. As of 2002, 85% of the cath labs use electronic archiving technology, which is up dramatically over the past five years. The availability of digital archiving within the cath lab has set the stage for the integration of cardiology information systems with cath lab images, noted Lorna Young, Senior Director, Market Research at IMV. Furthermore, of the sites that have cath lab review stations, over three quarters are connected to a network, which expands the way cardiologists can use these studies to manage their patients. IMV’s 2002 Cardiac Catheterization Lab Census Database provides comprehensive profiles of 1,630 sites, which comprise over 80% of the identified cath lab sites in the U.S. The database can be licensed by subscribers and includes contact and site-specific information regarding device utilization by manufacturer and contrast media utilization by brand, cath lab imaging systems, electrophysiology, intravascular ultrasound, digital imagers, filmless technology, hemodynamic systems, power injectors for cath contrast, plus cardiovascular information management systems and networking. IMV also performs customized analysis of the statistics to address specific client requirements. IMV’s 2002 Cardiac Catheterization Lab Market Summary Report is available with the database license or separately. It provides a comprehensive analysis of the cath lab market, and compares nationwide trends with the five prior census surveys that IMV has conducted since 1994. For more information, visit www.imvlimited.com. Part of Genetic Tie to Heart Disease Explained People with a genetic variation that affects immune system cells have a lower risk of suffering heart disease. Scientists at the U.S. National Institute of Allergy and Infectious Diseases made the finding while doing HIV/AIDS research. They did a detailed genetic analysis of more than 1,800 people and found that a genetic variant of the CX3CR1 receptor, called CX3CR1-M280, was associated with a significantly lower risk of heart disease. That held true even after the scientists adjusted for age, gender and negative risk factors such as high cholesterol, diabetes, smoking and hypertension. CX3R1 is a receptor molecule found on the surface of immune system cells. The genetic variation we studied has a positive and protective effect against atherosclerosis. This effect is similar in magnitude, though opposite in value, to known negative risk factors such as diabetes and smoking. In other words, as bad as the negative risk factors are bad, this factor is good, researcher Dr. Philip M. Murphy says. In addition, the study may explain part of the hereditary component of heart disease, establishing not only a genetic association but also giving evidence for a biological cause, Murphy says. By identifying a connection between the CX3CR1 receptor and atherosclerosis, the scientists have pinpointed CX3CR1 as a potential target for drugs that block its action. Medtronic Sees New Stent on Market by ‘05 Medtronic Inc.said it believes it could have a key cardiovascular treatment on the U.S. market by 2005. Drug-eluting stents are expected to revolutionize the treatment of coronary artery disease. In a bid to catch up to the competition, Medtronic last year struck a deal with Abbott Laboratories Inc. under which Medtronic would coat its stent with compounds made by Abbott and give Abbott access to certain of its stent delivery systems. If Medtronic meets certain milestones, it could be third on the market with a drug-eluting stent. Medtronic has an early study underway in Australia and expects to start a pivotal trial in Europe by September 2003. Hawkins said a smaller study in the United States to confirm the European results would likely commence in November or December of 2003. Hawkins said he hoped the company could submit a pre-market application to the Food and Drug Administration by the end of 2004 or the beginning of 2005 and win approval sometime in 2005. The next-generation coronary stents are expected to drive sales growth in the stent market, with some analysts estimating the market to more than double to $5 billion by 2005.

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