Clinical and Industry News for May 2007

Spectranetics Announces Commercial Availability of Turbo Elite Product Line Spectranetics Corporation announced the commercial availability of the Turbo elite product line for excimer laser ablation to treat peripheral artery disease (PAD). Driven by physician feedback, the Turbo elite product line features an enhanced outer jacket and inner guidewire lumen with optimized ablation efficiency and energy output enabling increased penetration rates. Spectranetics' Turbo elite excimer laser ablation system vaporizes lipid-based, calcified and fibrotic plaque as well as neointimal hyperplasia. It incorporates all of the features of the Turbo product line, including 80 hertz laser repetition rates, continuous on lasing and a hydrophilic coating. Turbo elite catheters are available in a variety of sizes. Laser ablation is an extremely safe and effective minimally invasive peripheral intervention treatment option, said Dr. Craig Walker of The Cardiovascular Institute of the South. It is successful in removing plaque and clot from blocked arteries to establish blood flow to the limbs. It requires less time and seems to have a lower risk than many other procedures that restore blood flow. Multiple publications have reported greater than 90 percent limb salvage rates without the need for open surgery in patients presenting with critical limb ischemia. The excimer laser ablation procedure usually takes only minutes. Patients remain awake during the entire procedure and typically experience no discomfort, Walker continued. Spectranetics' Turbo elite product line received FDA market clearance in October 2006 and launched a limited market release in the fourth quarter of 2006. The full product line is now commercially available. More information is available at www.spectranetics.com or by calling Spectranetics customer service at (800) 231-0978. COURAGE, SPIRIT Data Presented at the ACC Conference Support Role of Advanced Imaging and Diagnosis with IVUS and FFR Volcano Corporation summarized key data presented at the 2007 ACC Conference in New Orleans, LA, from March 24th to the 27th. Data presented at the conference suggests the need for more detailed imaging and diagnosis to optimize stent placement with technologies such as intravascular ultrasound (IVUS) and fractional flow reserve (FFR). John McB. Hodgson, MD, FSCAI, a Past President of the Society for Cardiovascular Angiography and Interventions, and Chief of Academic Cardiology at St. Joseph's Hospital and Medical Center in Phoenix, AZ, commented, Non-invasive imaging modalities, like CT angiography (CTA) and other screening tests, are very effective at guiding patients with coronary artery disease into the cath lab, and allowing interventional cardiologists to treat the patients that would clearly benefit from interventional therapy. However, these first-pass screening tests also bring patients into the lab with less severe disease. These patients may also benefit from medical therapy alone and effective follow-up. In many cases, physicians are presented with the dilemma of balancing a positive CTA with a negative angiogram, then having to choose between intervention and medical therapy. Technologies like IVUS and FFR provide important objective measures of disease severity - essentially serving as the 'tie breaker' in these patients as the data supporting lesion significance related to IVUS and FFR measurements has been well-studied. The COURAGE data showed that angioplasty and stenting did not reduce the risk of heart attack or death in the 2,300 patients who participated in the study with stable coronary disease versus medical therapy and lifestyle changes alone. Dr. Steven Nissen, president of the American College of Cardiology, said that Most heart attacks do not occur because of a blood clot at the site with the worst narrowing in the coronary. Most heart attacks occur at a site with relatively minor blockage in the coronary, and so the very sites where you put a stent are not the ones likely to cause the next heart attack or sudden death. He continued, Putting a stent in the most narrowed area in the artery doesn't really address the underlying problem. Scott Huennekens, President and CEO of Volcano Corporation, commented, Angiography alone is severely limited in this regard as it can only diagnose vessel narrowing in 2-D, and delivers no detail as to atherosclerotic plaque present or state of the disease at the narrowed, or the visually 'clear' parts of the artery. IVUS, on the other hand, provides a 3D 'slice' of the diseased artery so physicians can quickly and accurately measure minimum lumen diameter, remodeled vessel size, and cross-sectional flow area. Volcano's proprietary VH IVUS technology also provides a snapshot of the tissue type along the length of the artery, again providing more detail to supplement angiography. This technique - used as part of the PROSPECT trial - may deliver important insights into what a vulnerable lesion looks like before a heart attack. Dr. Hodgson notes, We learned from the DEFER study that FFR can be an effective way to assess lesion severity. By measuring the pressure gradient across a questionable blockage, FFR provides a key objective benchmark from which to guide appropriate therapy. If the FFR is below 0.75, data suggests the patient will benefit from stenting. If the FFR is above 0.75, data suggest the patient may benefit from medical therapy, follow-up and no stenting. FFR provides the physician with an effective diagnostic tool to determine the appropriate treatment of the lesion and patient. COURAGE data showed that 34% of patients in the stent group continued to experience angina 12 months after stent implantation. Scott Huennekens continued, This observation underlines the fact that in many cases we are either treating the wrong location because we didn't use FFR to measure lesion severity, or we are placing the stent sub-optimally because we are not using IVUS to ensure full apposition and expansion post intervention. Gregg W. Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation, presented IVUS data from the Abbott SPIRIT III US Pivotal study where the Xience drug-eluting stent was randomized against Boston Scientific Corporations's Taxus® stent. The data from the core lab showed that despite the importance of optimal stent placement as part of this key pivotal trial, of the 133 stents guided by angiography alone, stent mal-apposition was observed by IVUS in 34.4% in the Xience group and 25.6% in the Taxus group. Marco A. Costa, MD, PhD, FACC, FSCAI at the University of Florida, Shands Hospital in Jacksonville FL, commented that The prevalence of sub optimal drug-eluting stent deployment in patients guided by angiography in today's clinical practice is staggering. The STLLR study sponsored by Johnson & Johnson, using angiography-guided DES treatment in 1,419 patients, showed that current DES deployment techniques lead to some form of geographic miss in 66.5% of patients. What is more alarming is that geographic miss has in turn negatively impacted patient outcomes, with significantly higher TLR, TVR, and myocardial infarction rates in patients where the stent was not placed properly. A reexamination of stent placement technique, including the use of IVUS, is certainly warranted. Some Patients Who Must Pay Part of Statin Costs Discontinue Use Some patients required to partially pay for statins stop taking the potentially lifesaving, cholesterol-lowering drugs, according to a U.S. study of a Canadian system reported in Circulation: Journal of the American Heart Association. Researchers studied 51,561 patients who began taking statins to help prevent a heart attack. When the patients' drug insurance was switched from full coverage to a co-payment plan that required them to pay $10 or $25 Canadian currency (about $8.50 and $21 in American currency) per prescription, more than 5 percent stopped taking their medications or reduced the amount they took to such a low level that the drugs were ineffective. A 5 percent drop also was found in patients who were switched from the co-pay plan to a co-insurance system requiring them to pay 25 percent of a drug's cost. The magnitude of reduction in adherence surprised me, said Sebastian Schneeweiss, MD, ScD, lead author of the study and associate professor of medicine and epidemiology at Harvard Medical School in Boston, Mass. Five percentage points on a population level is substantial when you have hundreds of thousands of people on these medications. Though the study was done in Canada, researchers said the findings may have important implications for the new Medicare Part D drug coverage plan in the United States and private health insurers in both countries, Schneeweiss said. The Medicare prescription drug coverage requires participants to pay a monthly premium and co-payments or co-insurance payments (a percentage of the cost) for prescriptions. The costs of premiums and co-payments vary. Schneeweiss said cost-sharing plans aimed at reducing expenditures may instead lead to a costly under-use of lifesaving drugs. Health plans should consider whether implementing cost-sharing strategies for medications that are clearly proven effective, such as statins, deters patients from using these drugs on a regular basis, Schneeweiss said. Earlier this year, he and colleagues concluded in another study (Health Affairs, 26, no. 1 (2007): 186-194 doi: 10.1377/hlthaff.26.1.186) that insurers could save an average $5,974 per patient if they provided four drugs at no cost after a heart attack. The study found a combination of aspirin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors and statins would reduce recurrent heart attacks and the healthcare costs associated with them. In the adherence study, researchers tapped a natural experiment with three different drug coverage scenarios, Schneeweiss said. Until January 2002, the drug insurance plan of Canada's Province of British Columbia provided full coverage for elderly residents. At that time, the province instituted a co-payment policy in which most of those eligible paid $25 and low-income individuals paid $10 in Canadian currency. In May 2003, the province replaced its co-pay plan with a 25 percent co-insurance system that included an income-based deductible. The team examined three groups. One, the baseline group, consisted of patients who initiated statin treatment within six months of January 2001 - when there was full coverage. People in the second group began taking the drugs within six months prior to the change to co-payment in January 2002. And the third group initiated statin use in the six months prior to the co-insurance plan taking effect in May 2003. Initiation was defined as filling a statin prescription. Researchers followed patients' usage patterns for nine months. Those who took statins on 80 percent or more of the days intended were considered to be adhering to their prescriptions. The study's findings included: It confirmed previous studies that overall statin adherence is low among elderly patients. Compared to patients in the full-coverage group, 5.4 percent of patients who started statin treatment three months after introduction of either the co-pay and co-insurance plans stopped or reduced their statins. The median price paid by patients under the cost-sharing plans for a 90-day statin prescription was, in Canadian currency, $21.50 under the co-pay plan and $41.80 (about $18 and $35 in U.S. currency) under the co-insurance policy. Low-income patients showed a drop in statin adherence under the co-pay policy but not under the co-insurance plan. We speculate that the main reason is because co-insurance came with an income-based deductibility, Schneeweiss said. So cost was less of a factor for low-income patients. However, a lower income, no matter what a person's type of insurance, increased the likelihood he or she would stop statin use. The proportion of patients starting statin therapy after a heart attack rose by 1.7 percent per quarter. This rate of increase continued despite the changeovers to the two cost-sharing systems. An analysis revealed that when some co-insurance patients were required to pay 100 percent of the drug costs - equivalent to Medicare Part D's Doughnut Hole coverage gap - discontinued drug use increased almost two-fold compared to rates among patients with full coverage. Researchers did not try to determine if nonadherence adversely affected patients. It is tricky to study health outcomes here because they may not materialize for a year or two, or maybe 20 years later, Schneeweiss said. Intravenous Delivery of tPA Still Best Intervention for Ischemic Stroke Intravenous delivery of tissue plasminogen activator (tPA) remains the most beneficial proven intervention for ischemic stroke, according to updated American Heart Association/American Stroke Association guidelines, published in Stroke: Journal of the American Heart Association. The Guidelines for the Early Management of Adults with Ischemic Stroke also indicate that new options - such as intra-arterial administration of antiplatelet drugs and mechanical removal of blood clots - show promise. The guidelines focus on the crucial first hours from the time an ischemic stroke occurs through emergency evaluation and treatment in a hospital. Intravenous delivery of the clot-busting drug tissue plasminogen activator (tPA) is only approved to be used within three hours of symptom onset. The panel said other techniques - mechanical devices and intra-arterial administration (IA) of tPA - are becoming more widely available and should be considered for patients with moderate-to-severe strokes who arrive at the hospital too late to receive intravenous tPA. However, information on these techniques is limited and more research is needed. The new guidelines suggest emergency medical personnel perform a quick stroke assessment, draw blood and alert the hospital that a patient with a suspected stroke is coming. Patients should also be transported to the nearest appropriate hospital for emergency stroke care even if that means bypassing the closest facility or calling for air evacuation. Appropriate facilities are those with the expertise and resources to provide modern emergency stroke care. Regional plans for paramedics to bypass institutions that do not have emergency stroke care should be developed, according to the guidelines. The updated guidelines are an extensive revision of those issued in 2003 and 2005. Among the new or revised recommendations: Hospitals should develop emergency stroke protocols so patients can be assessed and treated within 60 minutes of arrival in an emergency treatment center. More medical centers should seek certification as primary or comprehensive stroke centers from the Joint Commission on Accreditation of Healthcare Organizations. Patients should receive early and carefully chosen treatments for abnormal blood pressure, fever or abnormal blood sugar levels, which can negatively affect stroke outcome. Although clot-dissolving drugs other than tPA are being tested, none has been established as effective and they should only be given as part of a clinical trial. For the first time, the association has included comments about palliative or comfort care of a patient with a devastating brain injury. We included this in the document so that physicians may recognize that they can take measures to not prolong suffering or dying in a patient whose extensive brain injury will result in a fatal outcome, Adams said. Stentys Positioning Next-generation Bifurcation Stent Stentys' (www.stentys.com) patent-pending bifurcated stent allows for the stent-opening for the side branch to be created anywhere in the stent after it is implanted in the vessel. The procedure's success is independent from accurate positioning. The Stentys procedure is performed in three simple steps: 1) Stentys is implanted in the main vessel with an approximate positioning, like a standard stent; 2) the cardiologist chooses the optimal location for the side branch opening by inserting a balloon through the stent mesh; and 3) the balloon inflation disconnects the mesh and creates the opening - the Stentys approach allows the in situ modeling of the stent to fit the patient's unique arterial anatomy. Stentys has appointed a Scientific Advisory Board (SAB) that includes some of the most prominent names in cardiology. The Stentys Scientific Advisory Board will include: Maurice Buchbinder, MD, director of interventional cardiology and co-director of the cardiac catheterization lab at Scripps Memorial Hospital, La Jolla, Calif.; Eberhard Grube, MD, chief of cardiology and angiology at the Helios Herzzentrum Heart Center, Seigburg, Germany, and a consulting professor of medicine at Stanford University; Jean-Claude Laborde, MD, co-director of the interventional cardiology unit at Clinique Pasteur, Toulouse, France; Thierry Lefevre, MD, head of interventional cardiology and research at the Institut Cardiovasculaire Paris Sud at Institut Hosptalier Jacques Cartier, Massy, France; and Patrick W. Serruys, MD, chief of interventional cardiology at the Thoraxcenter-Erasmus University, Rotterdam. Putting Compassion Back Into Patient Care Through Virtual Experience Technology WILL Interactive, Inc. and Washington Hospital Center Collaborate on New Simulation Learning Game, "Anatomy of Care" In a hospital, every encounter with a patient is important. Each encounter can influence patients and their families about the hospital experience and the medical care they receive. The quality of care and each customer's perception of that care have very real consequences for the success of the institution. Potomac, Md.-based WILL Interactive, Inc., focusing on virtual experience behavior modification gaming, is partnering with Washington Hospital Center in Washington, DC, to create a Virtual Experience Immersive Learning Simulation® (VEILS) addressing the critical area of customer care for hospital staff. Anatomy of Care is designed to educate all hospital staff from doctors to nurses, clerical staff to patient transporters and environmental services employees, as it demonstrates how their actions affect patient care and the overall image of a hospital. What Anatomy of Care is really about is being able to see the world through the eyes of one another," said Mark Smith, MD, Chairman of the Department of Emergency Medicine and ER One Institute at Washington Hospital Center, who is also a co-creator of Anatomy of Care. Anatomy of Care is a web-based training program designed to improve the way health care workers respond to difficult situations that confront them every day. Players choose one of five characters to role play (doctor, nurse, clerical, patient transporter and environmental service worker) at a fictional metropolitan hospital. In the VEILS, learners are presented with stressful slice-of-life scenarios in which they must make tough decisions and live out the consequences of their actions. Successful navigation of the interactive movie requires honest compassion, sensitive interpersonal dealings, and clarity of values. The goal of the simulation training is to improve behavior of hospital employees. Anatomy of Care allows users to play out difficult situations in the safety of cyberspace before they live them out. WILL Interactive's patented VEILS technology has been proven effective in changing behavior and enhancing positive decision-making. The experiential learning provided by WILL Interactive's simulations teaches users how to think rather than what to think. For more information, visit www.willinteractive.com. FoxHollow Announces FDA 510(k) Submission for The NightHawk System Real-Time Visualization Of Peripheral Vascular Morphology FoxHollow Technologies, Inc. announced a 510(k) premarket notification submission to the U.S. Food and Drug Administration for its NightHawk Plaque Excision System. The intended use of the NightHawk System is in the evaluation of peripheral vascular morphology. The NightHawk System brings together optical coherence tomography (OCT) technology with the FDA-cleared SilverHawk® System. The NightHawk device utilizes fiber optic technology embedded in the catheter and allows the physician to visualize the vascular morphology and wall structures. The OCT embedded catheters are designed for use as an adjunct to conventional angiography to provide an image of the vessel lumen and wall structures. In October 2006, FoxHollow announced the first in-man use of this new technology with encouraging results. Patients were treated at the American Heart of Poland Hospital in Bielsko by lead investigator Professor Pawel Buszman. The procedures were also attended by a team of U.S. interventional cardiologists, which included FoxHollow founder and CEO, Dr. John Simpson, Dr.Stefan Kiesz and Dr. Greg Robertson. In January 2007, FoxHollow conducted additional evaluations with the NightHawk technology by Professor Horst Sievert at the CardioVascular Center, Frankfurt Germany. Cordis Corporation and ClearStream Technologies Group, plc, Sign Distribution Agreement for Peripheral Angioplasty Balloon Catheters Cordis Corporation and ClearStream Technologies Group, plc, have signed a definitive distribution agreement whereby Cordis will market ClearStream's percutaneous transluminal angioplasty (PTA) balloon catheters under the brand names Sleek and Savvy® Long PTA Balloon Dilation Catheters. The Sleek and Savvy Long peripheral balloons will be marketed by the Cordis Endovascular division of Cordis Corporation. The companies expect the products will be commercially available in countries outside the United States starting in the second quarter of 2007. The Sleek and Savvy Long Balloons will feature lengths up to 120 mm for treating long diffuse disease, and a lubricious coating for increased crossability in tight lesions. The Sleek Balloon will be the first and only .014" guidewire compatible rapid-exchange (RX) balloon fully dedicated to infrapopliteal vessels, while the Savvy Long Balloon will provide an .018" guidewire compatible over-the-wire (OTW) alternative for both superficial femoral and infrapopliteal arteries.

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