Clinical and Industry News

Medcon Provides Cardiac Image Management and Archiving for The Children’s Hospital of Philadelphia The Children's Hospital of Philadelphia has selected Medcon Telemedicine Technology as a provider of cardiac image management and archiving solution for its cath labs after a thorough, nearly two-year evaluation of several vendors. The hospital’s cardiology department treats complex congenital heart diseases of all age groups, from newborns to adults. All types of interventions are performed on site. The facility has two cath labs and performs about 900 procedures per annum. The labs are equipped with Toshiba X-Ray machines. The search for a supplier started with Dr. Jonathan Rome, Director of Cardiac Cath Labs, identifying the clinical requirements for the filmless system. At the same time Information Systems department defined the technical infrastructure requirements. A resulting RFP document helped to select three potential vendors. This was followed by site visits to review each vendor's products in a clinical environment. "We chose Medcon's TCS” system based on several factors," stated Thomas Spencer, Manager of Ancillary Services, Information Systems. "First was system reliability. During our Medcon site visit it was commented that the film had come off the cameras two years prior without any need to revert to film thereafter. Second was the system’s performance and ease of use for our physicians. We did not want the technology to interfere with the ability of our physicians to deliver patient care." David Donnelly, RN, Cath Lab Manager, added, "Our IS team was very pleased with the platform-based hardware system and the DVD archival." Medcon connected its TCS acquisition stations in the labs and TCS review workstations throughout the enterprise. Mr. Donnelly commented, "Our physicians have been especially satisfied with the image quality. The ability to e-mail images internally from review stations to doctors’ desktops for publishing is very appealing. Images can be seen in any location as acquired. Moreover, we are pleased that there has never been a case that we could not complete." Guidant’s Multi-Link Stents Demonstrate Benefit to Heart Attack Patients Guidant Corporation gained approval from the U.S. FDA for use of their Multi-Link family of stents in patients presenting with acute myocardial infarction. This expanded indication follows FDA approval of data from Guidant's CADILLAC trial, which found that stent implantation should be considered a routine strategy for restoring blood flow to the heart following a heart attack. Guidant's Multi-Link 2.5 to 4.0 mm stents are the first products approved by the FDA for use in this indication. The CADILLAC trial demonstrated conclusively that Guidant Multi-Link and Multi-Link Coronary Stents provide immediate benefits to patients presenting with acute myocardial infarction by rapidly restoring blood flow. The study found that when compared to balloon angioplasty alone, patients implanted with stents following acute myocardial infarction had a nearly 50 percent reduction in major adverse cardiac events (MACE). Major cardiac events included death, recurrence of heart attack, disabling stroke, and recurring occlusion (blockage) of the vessel that contributed to the original myocardial infarction. Guidant Corporation conducted the international CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) clinical trial to establish safety and efficacy for use of Guidant coronary stents in patients presenting with acute myocardial infarction. The CADILLAC trial provided a randomized comparison of four strategies for restoring blood flow to the heart: balloon angioplasty alone, balloon angioplasty plus the drug abciximab, stent alone and stent plus abciximab. The stent alone as compared to balloon angioplasty alone and balloon angioplasty plus abciximab proved to be statistically significant in reducing 180-day MACE rates. Progress Toward FDA Approval of the EPT-1000 XP Cardiac Ablation System for Atrial Flutter Boston Scientific Corporation has announced progress toward PMA from the U.S. FDA for its EPT-1000 XP cardiac ablation system for the treatment of atrial flutter. Six of the seven PMA modules submitted by the company have been reviewed, accepted and closed by the FDA. The seventh and final module is currently under review. Boston Scientific filed its application with the FDA in the second quarter of 2002. Approval of the seventh module is the final step required for a PMA, which would allow product commercialization in the United States. The EPT- 1000 XP cardiac ablation system uses radiofrequency (RF) to treat this condition by creating a linear lesion across the tricuspid isthmus, interrupting the abnormal electrical circuit causing the atrial flutter and allowing the heart to return to normal rhythm. Historically, patients with atrial flutter have been treated using a variety of methods such as electrical cardioversion and anti-arrhythmic drugs. However, these approaches are palliative and the arrhythmia may require alternative treatment. RF cardiac ablation offers a viable alternative to these palliative treatments. The EPT-1000 XP cardiac ablation system provides increased benefit in the treatment of patients with atrial flutter, said Dr. Gregory Feld, Professor of Medicine, Director of the Electrophysiology Program at the University of California San Diego Medical Center and Principal Investigator of Boston Scientific's atrial flutter study. Our experience in treating atrial flutter shows a definite advantage to using a 10mm tip catheter, such as the BLAZER II XP, and a power generator with up to 100 watts of RF power. The results of this multi-center study show shorter procedure times with fewer ablations and a cure rate in excess of 95 percent. As a consequence, patients reported a dramatic improvement in their quality of life after being treated with the EPT-1000 XP cardiac ablation system. The Boston Scientific atrial flutter system consists of a family of BLAZER II XP bi-directional, temperature-controlled cardiac ablation catheters and the EPT-1000 XP generator. While the new EPT-1000 XP generator is essentially the same as the currently available EPT-1000® generator installed in the majority of U.S. cardiac ablation centers, the forthcoming version will increase the available RF power level from 50 to 100 watts. CardioGenesis Ranked Among Nation’s Most Inventive Entrepreneurial Firms CardioGenesis Corporation, a Foothills Ranch, CA, company involved with the procedures of Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Revascularization (PMR), has been recognized by Inc magazine as one of the most inventive small companies in the country. CardioGenesis was ranked 17th in the magazine's listing, called The Innovation 50. The ranking was based on a variety of factors, including the holdings in a company's intellectual property portfolio and its total number of issued patents. CardioGenesis currently owns 77 patents, most of them in the laser medical device and laser handpiece fields, and the substantial majority of them based on technology created to facilitate the treatment of different aspects of cardiovascular disease. One significant component of the Company's intellectual property portfolio is its PMR system, a catheter-based, minimally invasive laser treatment for the relief of angina. PMR, potentially one of the most important recent advances in cardiology, is currently under review by the U.S. Food and Drug Administration. More than 2,000 patients have already successfully undergone the PMR procedure in Europe, Asia and Canada, where it is actively being marketed. For more information on the Company and its products, please visit the CardioGenesis web site at www.cardiogenesis.com. Guidant Agrees to Acquire Cook Group Incorporated Guidant Corporation and Cook Group Incorporated jointly announced that Guidant has agreed to acquire Cook Group Incorporated in a stock-for-stock transaction. This transaction strategically positions Guidant for long-term global leadership in the emerging drug eluting stent market. Under the agreement, Guidant will acquire all of Cook Group Incorporated for up to $3 billion in Guidant stock, subject to a maximum issuance of 65.79 million Guidant shares, priced in two phases. The first phase will be priced at a minimum of $40 per Guidant share, with a maximum number of shares issued of 41.25 million. The second phase will be priced at a minimum of $55 per Guidant share, with a maximum number of shares issued of 24.54 million. At the maximum share issuance, the transaction is expected to be earnings neutral in 2003 and substantially accretive in 2004. Guidant's obligation to complete the acquisition is subject to certain clinical and legal conditions relating to the Achieve Drug Eluting Coronary Stent System. The conditions include positive clinical results and Guidant’s rights to use certain clinical data and to sell the Achieve product. The parties anticipate closing in early 2003, subject to the satisfaction or waiver of conditions. European Study Concludes Complete Laser Debulking Leads to Better Long-Term Restenosis Results than Brachytherapy The Spectranetics Corporation announced the results of a study demonstrating that aggressive excimer laser debulking of in-stent restenosis (ISR), using Spectranetics’ excimer laser, results in a low binary stenosis rate of 20% and target lesion revascularization rate (TLR) of 17%. These data compare favorably to restenosis rates reported for brachytherapy. The study analyzed retrospective data on 82 patients with diffuse in-stent restenosis who were treated with excimer laser atherectomy followed by adjunctive balloon angioplasty. Johannes B. Dahm, MD and study researcher, commented: Our study suggests the amount of initial laser debulking is an independent predictor of binary stenosis, TLR and major cardiac event rates. The data show that aggressive debulking, resulting in a diameter stenosis of less than or equal to 30%, leads to more favorable outcomes than if less debulking is performed. Indeed, long-term restenosis rates are better in this group than those reported for brachytherapy. Previously published laser studies in ISR have shown conflicting outcomes possibly due to less aggressive debulking techniques and older catheter technology. A subanalysis of these older papers, however, supports our data by revealing far superior acute and long-term results for cases in which effective laser ablation has occurred. The study divided the patients into two groups according to their primary laser debulking results. The study compared percentage of binary stenosis, TLR and Major Adverse Cardiac Event (MACE) rates at six months for the two groups. The data were significantly more favorable in patients who had greater amounts of tissue ablated by laser debulking than for patients who had only a limited reduction of diameter stenosis. Medtronic Announces First in Next Generation of Guide Catheters for Angioplasty Medtronic, Inc.’s new Launcher guide catheter, now available in the 6-French size in most markets worldwide, is intended to complement Medtronic's Z2 and ZUMA guide catheters, by combining a large lumen and features such as balance, flexibility and support. The lumen of the 6-French Launcher guide catheter is 0.071 in diameter, larger than competitive 6-French catheters and thus able to accommodate a greater flow of marker dyes and all Medtronic coronary stents and balloons. The 6-French Launcher guide catheter’s outer diameter results in smaller incisions that are less traumatic to the patient during and after surgery. Unlike most comparably sized guide catheters, the 6-French Launcher guide catheter is uniquely engineered to give physicians both flexibility and support. The new guide catheter features Medtronic’s Full Wall Technology in a Vest-Tech nylon and an encapsulated flat-wire braid. It is crafted to maximize support and curve retention, which allow it to remain firmly in place during subsequent interventional cardiology procedures. The material is kink-resistant and fully radiopaque, facilitating visualization on fluoroscopy, while its support, curve retention, flexibility and controlled torque allow precise placement. The 6-French Launcher guide catheter includes a full line of standard and specialty curves. The company plans to launch the new guide catheter in a full complement of French sizes. Novartis Files SNDA For Lescol® For Secondary Prevention of Cardiovascular Events In Angioplasty Patients Novartis Pharmaceuticals Corporation has filed supplemental new drug applications (SNDA) for Lescol® (fluvastatin sodium) and Lescol® XL (fluvastatin sodium) 80 mg extended-release tablets with the U.S. Food and Drug Administration (FDA) for secondary prevention of cardiovascular events in patients who have undergone percutaneous coronary intervention (PCI) procedures, such as angioplasty. In the U.S. approximately one million patients undergo these procedures each year. Lescol and Lescol XL, commonly prescribed cholesterol-lowering medications, are the first statin products to seek an indication in this patient population. Filings for the new indication are also being initiated with health authorities in major international markets. The FDA submission is based on the positive findings of the landmark Lescol Intervention Prevention Study (LIPS), which was recently published. LIPS assessed the effect of Lescol 80 mg daily in patients with coronary artery disease who had undergone a first PCI. This patient population has early stage coronary heart disease and is at high risk of a second major adverse cardiac event. Of the one million patients in the U.S. who undergo surgical procedures including angioplasty each year, nearly 40 percent will have a heart attack or undergo a second procedure within five years following their first successful angioplasty. LIPS was a four-year study involving 1,677 patients in 10 countries and was the first prospective, randomized, placebo-controlled trial to evaluate the effects of a statin exclusively in patients who had a first PCI. The study looked at the time to first major cardiac event (MACE), which was defined as cardiac death, nonfatal heart attack, coronary artery bypass grafting or repeat PCI. Patients were randomized to receive either Lescol 80 mg (40mg twice daily) or placebo, before hospital discharge after their first coronary surgical procedure. LIPS demonstrated Lescol 80 mg significantly reduced the risk of fatal and serious nonfatal cardiac events by 22 percent (p= 0.013) in patients with normal cholesterol levels after undergoing a first angioplasty. LIPS also provided Lescol safety data. In the study, there were no significant elevations of creatine phosphokinase (CPK) above 10 times the upper limits of normal (ULN) over the three to four years of follow up. Elevated CPK is an indication of muscle breakdown and is a potential side effect of statin therapies. These safety data match those from a recent analysis involving more than 9,000 patients in clinical studies who were taking fluvastatin, in the forms of Lescol or Lescol XL. That analysis found the rate of clinically relevant CPK elevations was not significantly different than the rate seen in patients receiving placebo. Lescol and Lescol XL are indicated as an adjunct to diet to reduce patients' elevated total cholesterol, LDL-C, TG and apolipoprotein B (Apo B) levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. Lescol and Lescol XL are also indicated to slow the progression of atherosclerosis in patients with coronary heart disease. Beyond the benefits seen with Lescol in post-PCI patients, the effect of Lescol and Lescol XL on cardiovascular morbidity and mortality has not been determined. The independent effects of raising HDL-C or lowering TGs on the risk of coronary and cardiovascular morbidity and mortality have not been determined. Lescol capsules and Lescol XL tablets are well-tolerated prescription medications that should be used in conjunction with changes in diet, for the treatment of high cholesterol. Physicians should perform blood tests before and during treatment to check for liver problems. Patients should not take Lescol or Lescol XL if they are nursing; are pregnant or may become pregnant; have liver problems; or are allergic to any of the ingredients. Possible side effects may include upset stomach, insomnia, upper respiratory tract infections, flu-like symptoms, back pain or headache. Unexplained muscle pain, tenderness or weakness could be a sign of a serious side effect and should be reported to the patient’s doctor immediately.

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