CLINICAL AND INDUSTRY NEWS

Study Shows Pre-Hospital Administration of RETAVASE® Can Accelerate Important Treatment of Heart Attack Patients A recent study has found that the time required to begin the treatment of heart attack patients could be cut by more than half by having the clot-dissolving drug Retavase® (reteplase) administered by ambulance crews rather than waiting until patients reach a hospital. The trial, known as Early Retavase-Thrombolysis In Myocardial Infarction (ER-TIMI) 19, was conducted in states where pre-hospital administration of fibrinolytic drugs such as Retavase currently is authorized. It found that for patients receiving pre-hospital treatment, the median time was 31 minutes from the arrival of Emergency Medical Services (EMS) to the first injection of Retavase. This was less than half of the median time of 63 minutes it had taken to start in-hospital thrombolytic treatment in the cohort of historical control patients who had been admitted to the same hospitals during the year prior to the start of the study. We know that time is of the essence when a heart attack patient's life is on the line, said U.S. Representative Mark Foley (R-FL), a member of the U.S. House Ways and Means Committee who has backed federal legislation to authorize pre-hospital administration of life-saving drugs by paramedics. This study also shows that valuable time could be saved if the laws in every state allowed patients to be treated with breakthrough therapies before they get to the hospital. Retavase is administered as two intravenous injections 30 minutes apart, with the same dosing used in all patients independent of their body weight, said Michael Waller, MD, Centocor’s senior director, clinical trials management, North America. This mode of administration makes Retavase suited to be given outside the hospital, he noted. Following pre-hospital treatment with Retavase, physicians still have the option to send the patient directly on to an interventional procedure if necessary. Retavase is also the only fibrinolytic proven superior to t-PA in restoring TIMI 3 flow at 60 and 90 minutes after administration. New Release of VERICIS® PhysioLog Hemodynamic Monitoring & Data Management System Camtronics Medical Systems, a subsidiary of Analogic Corporation, announced a new release of its VERICIS® PhysioLog Hemodynamic Monitoring and Data Management System that features patient data collection, waveform visualization, and customizable management reports. The new release of PhysioLog, which recently received FDA market clearance, features a new table rail-mounted, compact patient data module that integrates 12-lead ECG, respiratory rate, 2-4 invasive pressures, NIBP, SpO2, thermodilution cardiac output and a programmable ECG or invasive pressure analog output. New waveform visualization software allows clinicians to view pressures, respiratory rate, ECG waveforms and thermodilution cardiac output in multiple formats or on one screen. The color-coded display is designed for optimal visibility and easy-to-identify vital signs. Waveform presentation is manipulated through a simple setup menu. VERICIS PhysioLog integrates complete functionality for real-time waveform analysis, data collection, inventory management, patient charging, image capture/analysis and procedural reporting into a single, easy-to-use system. A unique touch-screen interface makes data collection fast, accurate, and consistent from lab to lab and user to user. VERICIS for Cardiology is the first image and information management system that captures patient information across the continuum of cardiovascular care. The standards-based VERICIS platform integrates data from different sites (physician office, clinic, hospital) and different sources (interventional and diagnostic x-ray angiography, echocardiography, nuclear cardiology, MR, hemodynamics, reports, HIS) to create a comprehensive digital record on the cardiac patient. LUMEDX Announces Free CD Lumedx Corporation has announced the availability of a complimentary CD based on the co-presentation given by Lumedx and the American College of Cardiology at this year's Cath Lab Digest Annual Symposium on Cardiovascular Care: The Power of Data Integration: How Cath Labs today are using software to deliver quality, cost-effective care. Featured speaker Pamela Goepfarth, RN, CCRN, RCIS, Database Administrator, Saint Vincent Heart Center, Erie, Pennsylvania, discussed how the Cardiology team at Saint Vincent developed a Quality Dashboard of indicators and used powerful software to: Reduce cath lab workload Promote quality assurance Contain inventory costs Establish return on IT investments Saint Vincent Heart Center reported a total savings of $1,038,000 in the cath lab over an eighteen-month period using the Lumedx Apollo Clinical Information System. You can request a complimentary copy of the CD containing real-life applications by going to https:// www.lumedx.com/asocc/. Over three hundred leading heart centers worldwide use the Lumedx Apollo Cardiovascular Information System for patient reports and clinical outcomes analysis. Lumedx can be found on the web at www.lumedx.com. FDA Clearance for Endovascular Temperature Management System Radiant Medical, Inc. has received clearance from the U.S. FDA to market its SetPoint® Endovascular Temperature Management System. The SetPoint Endovascular Temperature Management System is the first system of its kind cleared by the FDA. It utilizes a catheter-based technology to control the patient’s core body temperature. Clearance by FDA was based on the results of a clinical study where the device was shown to effectively cool or warm a patient's blood to achieve and/or maintain normothermia during cardiac surgery and in the post-operative intensive care environment. The SetPoint System currently is being evaluated in clinical trials of endovascular therapeutic cooling in heart attack (the COOL-MI trial) and stroke (the COOL-AID trial). Kensey Nash Announces Commercialization of TriActiv Distal Protection System in Europe Distribution Agreements Executed for United Kingdom, Switzerland and Austria Territories Kensey Nash Corporation has successfully commercialized its TriActiv Balloon Protected Flush Extraction System in Europe during the June quarter. The TriActiv System is designed to prevent heart attacks during the interventional treatment of saphenous vein grafts (SVGs) in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The device incorporates three important features to address the common problem of distal embolization: a protection balloon guidewire which creates a protected space, a flush catheter which washes the graft, and an extraction system which removes the debris found in the grafts. A U.S. randomized trial, the PRIDE trial (PRotection during saphenous vein graft Intervention to prevent Distal Embolization), commenced in December 2001. The ongoing trial is being conducted at up to 50 sites and, upon completion, will involve up to 800 patients. Forecast of 20% Annual Growth for Adjunctive Coronary Transcatheter Market While attention remains focused on the multi-billion dollar promise of drug-eluting stents, a number of important adjunctive coronary transcatheter (ACT) technologies are expected to experience dramatic growth over the next five years as product refinements and approvals allow them to evolve from promising to compelling within interventional coronary medicine. Collectively, sales of these ACT products are projected to grow 19.8% annually to generate an estimated $1.1 billion market by the year 2006. Newer, specialized products, such as embolic protection systems and transcatheter defect repair devices, will experience the most significant gains, posting annual sales increases of 91% and 51%, respectively. Mechanical thrombectomy systems, used in both peripheral and coronary applications, will also see major growth. However, arterial closure devices will remain the largest segment of the ACT market throughout the forecast period. These are among the findings of Health Research International’s comprehensive new report on High Growth U.S. Adjunctive Coronary Transcatheter Markets, marketed by Medtech Insight. Encompassing more than 425 pages, it provides detailed information and analysis on arterial closure devices, debulking technologies (including atherectomy and laser angioplasty), embolic protection devices, mechanical thrombectomy systems, percutaneous defect closure devices, and emerging technologies such as hyperoxemic reperfusion, intravascular hypothermia, and catheter-based methods used to diagnose and manage vulnerable plaque. Supplier shares are provided for each major product type, and the market forecasts, incorporate intensive econometric analysis of leading indicators, penetration rates and product usage per procedure, as well as the important clinical and cost considerations driving usage. GALAXY Trial Investigates the Use of the aSpire® Covered Stent for the Treatment of Iliac Artery Stenoses and Occlusions Vascular Architects, Inc., announced the start of a Phase II clinical trial evaluating use of the Vascular Architects aSpire® Covered Stent and Controlled Expansion Delivery System for the treatment of iliac artery stenoses and occlusions. The Vascular Architects-sponsored Phase II trial, known as GALAXY (investiGAtionaL use of the Aspire covered stent with controlled eXpansion deliverY system in iliac artery stenoses and occlusions), is a non-randomized trial that will enroll up to 200 patients with stenoses or occlusions of the iliac artery. This study is being conducted at 30 sites throughout the U.S. and will utilize the aSpire Covered Stent. The first patient was successfully treated by Reynaldo Mulingtapang, MD, at St. Petersburg General Hospital in St. Petersburg, Fla. Vascular Architects has previously reported on the results of its Phase I SFA/iliac feasibility trial in patients and, in particular, reported that when considering all patients enrolled in the trial pretreated with balloon dilatation only followed by the aSpire Covered Stent (25 patients, 27 legs), primary patency is 100% with an average follow-up of 9 months. The clinical data collected from the Phase I feasibility study investigating the use of the Vascular Architects aSpire Covered Stent in iliac occlusions and stenoses was exceptional, especially the data generated from patients pretreated with balloon dilatation only followed by the aSpire Covered Stent, said Gary Ansel, MD, of Riverside Methodist Hospital in Columbus, Ohio, who will serve as the principal investigator of the GALAXY Trial. I am anxious to collect the data generated from this trial, including the data generated from stenting external iliacs, which have historically not shown good patency rates following stent implantation. The aSpire Covered Stent is a spiral nitinol stent completely covered by a thin layer of ePTFE, which is intended to provide greater lumen wall coverage and eliminate metal-to-artery interaction. The aSpire Covered Stent is designed to handle the functional stresses placed on stents used in the lower extremities. At the same time, the design of the aSpire Covered Stent helps to preserve many of the desired elements of the native lumen, including the ability to maintain side branch access. The aSpire Covered Stent is delivered using Vascular Architects' proprietary Controlled Expansion delivery system. The Controlled Expansion delivery system enables physicians to visually confirm the stent's location before it is deployed, enabling them to reposition and appose it again and then deploy. This delivery system is still the only stent delivery system available today that separates the steps of complete stent apposition and deployment. The aSpire Covered Stent and Controlled Expansion Delivery System has been cleared in the U.S. for the treatment of tracheobronchial strictures, and has received its CE mark in Europe for treating peripheral vascular disease. The company also markets the MollRing Cutter in the U.S. and Europe for the minimally invasive treatment of iliac and SFA occlusive disease by a procedure known as remote endarterectomy. Vascular Architects is privately held with investors that include Medtronic and Johnson and Johnson. Angioplasty Beats Clot-Busting Drugs Even with Delays in Transferring Patients, Study Suggests Heart attack patients fare better with angioplasty than thrombolytic therapy even when they have to be transferred to another hospital, suggests a new study. We know from previous studies that primary angioplasty is better than thrombolytic therapy, said lead author Cindy L. Grines, MD, of William Beaumont Hospital in Royal Oak, Mich. What nobody knew was whether angioplasty’s advantage would be maintained if there was a time delay if, for example, a patient had to be transferred from a very small hospital to a big interventional center." To answer that question, Dr. Grines and an international group of researchers randomly assigned 138 high-risk heart attack patients to receive on-site thrombolysis or be transferred to a facility with the capacity to perform angioplasties. What the researchers found didn't surprise them: Despite delays, the patients who were transferred for angioplasty seemed to do better than those who received on-site thrombolysis. The transfer group showed a 38 percent reduction in their rate of death, disabling strokes, and subsequent heart attacks a month after treatment, although the sample size was too small to allow for statistical significance. What was surprising, said Dr. Grines, was the length of the delays in transferring patients. The interval between arrival and treatment was 51 minutes for the thrombolysis group and a whopping 155 minutes for the transfer group. Waiting for an ambulance to show up to transfer the patient represented the biggest part of the delay. Although 911 calls from patients at home typically have a response time of five minutes," Dr. Grines noted, the time from the request to when the ambulance showed up at the hospital was 43 minutes! Stent Will Release Drugs that Activate a Novel Angiogenic Pathway Mediated By Non-Neuronal Nicotinic Acetylcholine Receptors Endovasc Ltd., Inc. has filed a patent application for a method for stimulating growth of new blood vessels in the heart and limbs by stent-released therapeutic amounts of its new drug Angiogenix (a nicotine acetylcholine receptor agonist). According to Endovasc VP of Research and Development, Dr. Diane Dottavio, We have submitted an abstract on our discovery to a major heart conference that describes our process in detail, but suffice to say at this time, stents may provide a much safer and effective method of releasing drugs that stimulate the angiogenesis. Though our results with endocardial catheters have effectively demonstrated the efficacy of intracatheter needle injection in the heart, the technique requires considerable skill and some very expensive equipment. Endovasc estimates that the current market potential for its Angiogenix stents is approximately $1 billion per year. Dr. David P. Summers, Chairman and CEO said, We made a choice to establish a joint venture with MIV Therapeutics primarily because they chose our PROStent therapeutic as a coating for preventing restenosis, and our PROStent coating process is cross-transferable to Angiogenix coatings. They also have a superior stent and manufacturing capability that will speed up the development. The Company said it had plans to test the concept at Columbia University in Dr. Dan Burkhoff's laboratory this fall. Hyseq Pharmaceuticals Initiates Phase I Trial for Lead Product Candidate Alfimeprase Hyseq Pharmaceuticals, Inc. announced the initiation of a Phase I clinical trial of its novel acting thrombolytic, alfimeprase, in patients with peripheral arterial occlusion (PAO). The multi-center, open-label, dose-escalation study to evaluate alfimeprase’s safety and pharmacokinetics, will be conducted in twenty patients across six centers in the U.S. Alfimeprase is a more direct thrombolytic, both in its mechanism of action and its method of delivery than traditional plasminogen activators or currently available drugs in this class, said Dr. Ted Love, president and chief executive officer of Hyseq Pharmaceuticals. Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase's novel clearance mechanism dramatically limits the molecule's half-life, reducing the risk of bleeding complications, a common side-effect of current therapies. Bypass surgery and angioplasty are established treatments for PAO; however treatment with thrombolytic drugs has presented a less-invasive and more cost-effective alternative. There are currently no products on the market approved to treat PAO. With the limited treatment options currently available, alfimeprase has received Orphan Drug designation for the PAO indication. Fluvastatin Reduced Risk of Serious Cardiac Events in Patients Following First Angioplasty Results of the Lescol Intervention Prevention Study (LIPS) demonstrated that cholesterol-lowering medication fluvastatin 80mg reduced the risk of fatal and serious nonfatal cardiac events by 22 percent in patients with average cholesterol levels after undergoing a first angioplasty.¹ The study demonstrated that early treatment with fluvastatin post-PCI would be both cost effective and socially beneficial by preventing one fatal or non-fatal major adverse cardiac event in every 19 people treated for four years. ¹ The fact that the study population had a mean LDL cholesterol level of 132 mg/dL [3.4 mmol/L] within the upper end of the normal range suggests that the decision to begin statin therapy should be based on an overall risk assessment of a patient and not just baseline cholesterol levels. The LIPS findings were clinically significant and showed how the outcomes of post-PCI patients can be markedly improved with fluvastatin therapy, said Patrick WJC Serruys, MD. LIPS is the only statin study in this high-risk patient population, and the data will have lasting implications on the treatment of the post-PCI patient population. LIPS is the first prospectively designed, double-blind, placebo- controlled study to evaluate the effect of a statin, specifically fluvastatin, exclusively in patients who had undergone their first PCI. The four-year study followed 1677 patients recruited from 57 centers in 10 countries. Major adverse cardiac events were defined as cardiac death, nonfatal heart attack, coronary artery bypass grafting, or repeat PCI. ¹ In addition to the 22 percent reduction in serious adverse cardiac events (p=0.013), the LIPS study demonstrated fluvastatin 80mg (40mg twice daily) provided a greater benefit in certain high-risk patients compared to placebo. Patients with diabetes (12 per cent of the total study population) experienced a 47 per cent reduction in the risk of experiencing a serious cardiac event, as compared to placebo (p=0.041). Additionally, patients with multi-vessel disease, meaning they had blockages in more than one artery (37 per cent of the total study population), experienced a 34 per cent reduction in their risk of a major cardiac event (p=0.011). ¹ Interestingly, patients with unstable angina in the fluvastatin arm of the study experienced a greater risk reduction than patients with stable angina (28 per cent versus 20 per cent, respectively). Patients treated with or without stents during their first PCI experienced similar benefits from fluvastatin therapy. ¹ LIPS also yielded important long-term safety data in this high-risk patient population. In LIPS there were no significant elevations of creatine phosphokinase (CPK), a possible side effect of cholesterol-lowering statin therapies and an indication of muscle breakdown. ¹ Professor Serruys noted fluvastatin was used in this study because of its established safety profile and pleiotropic effects. The LIPS data support other research in this area suggesting that treatment with statins may have a positive impact on a number of other aspects of arterial plaque buildup, including the migration of cells and the function of endothelial tissue. ² LIPS was sponsored by Novartis Pharma AG, manufacturers of fluvastatin. References 1. Patrick WJC Serruys, MD, PhD, et al. Fluvastatin for Prevention of Cardiac Events Following Successful First Percutaneous Coronary Intervention. JAMA 2002; 287:3215-3222 2. Vaughan CJ, Gotto AM Jr, Basson CT. The evolving role of statins in the management of atherosclerosis [review]. J Am Coll Cardiol 2000;35:1-10. New Actalyke® MINI ACT Analyzer The Actalyke family of activated clotting time products has been expanded to include the Actalyke MINI. The MINI has high sensitivity and 2-point clot detection for greatest reliability. Performance, linearity and CVs parallel larger Actalyke analyzers. The MINI features a small 6 footprint, but has a very large high visibility screen. The display can be read in any lighting situation. Operation of the MINI is simple. Just insert the ACT reagent tube containing whole blood and push the button. Results are clearly displayed. An optional printer is also available. The MINI is compatible with all ACT tubes. Helena offers a full line of Actalyke ACT tubes, including traditional glass bead, kaolin, celite plus new MAX-ACT. Toshiba Receives FDA Clearance for CT Scanner Toshiba America Medical Systems (TAMS) has received U.S. FDA marketing clearance for the Aquilion 16, the 16-slice computed tomography (CT) scanner that is four times faster and captures more anatomical information than previous CT technologies. The speed and clinical accuracy of this technology offers significant benefits to patients, especially trauma, pediatric and critically ill patients. by enabling physicians to more clearly visualize internal injuries and disease with faster and easier studies. For example, the time required to complete a CT angiogram that scans from the abdomen to the feet (2 mm slice thickness) is reduced from 60 seconds to only 15 seconds. The system’s design has a unique 40-row Quantum detector that is capable of generating 16 simultaneous 0.5 mm slices with each 500-millisecond gantry revolution. The Aquilion 16 is the only scanner that delivers 16 slices as thin as 0.5 mm, in one gantry rotation, capturing more detail of internal anatomy such as small arteries or subtle abnormalities in an organ. As a result, physicians are able to see more than ever before for increased diagnostic confidence and accuracy. We have seen multi-detector CT be incredibly useful in surgical planning and noninvasive post-procedural follow-up, said Kieran Murphy, MD, and director of Interventional Neuroradiology, Johns Hopkins Medical Institutes. Half-millimeter isotropic resolution scanning virtually eliminates artifacts from implanted devices. The reduction in catheter angiography reduces stroke risk and helps in the evaluation of vasospasm. As the number of slices has increased, we have been able to increase coverage without sacrificing speed or resolution. The Aquilion 16 also features Toshiba's proprietary algorithm that was specifically designed for the new 16-slice CT scanner to deliver the best possible image quality. This reconstruction technique virtually eliminates artifacts. The faster speed and enhanced image quality of the Aquilion 16 also significantly enhances a clinician's ability to perform cardiology studies. In the past, this has been a challenge for CT due to the speed of the heart motion and the small size of the coronary arteries. With the advanced CT technology, physicians will be able to more easily view coronary arteries to detect heart disease. This technology will enable many patients to undergo less invasive procedures that will no longer require having a catheter inserted in an artery and maneuvered up to the heart for imaging. FDA approves Over-the-Wire Coronary Stent with Tip Technology The U.S. Food and Drug Administration will allow Cordis Corporation to market the new Bx SONIC Over-the-Wire Coronary Stent. This product is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo and restenotic lesions in native coronary arteries with reference diameters from 3.0 mm to 5.0 mm. The Bx SONIC Stent is also indicated for the treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions with reference diameters from 2.25 mm to 4.00 mm. With its self-centering JET-TIP Tip Design, the Bx SONIC Stent is engineered to facilitate smooth navigation and delivery in tortuous anatomy and challenging lesions. The catheter utilizes the DIRECTSEAL Sealing Process, a proprietary process engineered for improved crossability, providing seamless tip-to-balloon transition to cross challenging lesions more successfully. Additionally, the system contains a new, shorter balloon made with DURALYN® semi-compliant balloon material with minimal overhang, designed to reduce the risk of edge dissection. The Bx SONIC Stent features FLEXSEGMENT Technology that links the support struts to form a fully connected, conformable, closed-cell while providing maximum scaffolding with minimal plaque prolapse. To meet the distinct challenges of small, medium and large vessel sizes, the stent is engineered with 6, 7, and 9-cell support structures. For more information on the Bx SONIC Coronary Stent, see www.BxSONIC.com.

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