Clinical and Industry News

LuMend Launches New, 50% Smaller CTO Catheter Platform LuMend Corporation, developing technology for crossing chronic total occlusions (CTOs), has launched its fifth-generation catheter platform, the Frontrunner® X39 CTO Catheter. The Frontrunner X39 is approximately 50% smaller compared to previous generations. The company also reported safety data for blunt micro-dissection, the technology behind the Frontrunner family of catheters. The Frontrunner X39 Catheter is used to treat CTOs. It has a distal tip size of just .039 with a 30% increase in distal tip opening power compared to previous generations. This allows for enhanced distal tip engagement within the blockage, a critical factor in crossing the CTO. Because of the catheter’s small size, it handles like a guide wire. The Frontrunner X39 Catheter uses controlled, blunt micro-dissection to gently separate atherosclerotic plaque, creating a passage through the CTO. The original Frontrunner device was initially launched in April 2002. Now, over 180 hospitals are ordering the device, and approximately 250 interventional cardiologists are trained. It is estimated that CTOs are present in approximately one third of all diagnostic angiograms completed on patients with coronary artery disease. Robert K. Strumpf, MD, Director of Interventional Cardiology at the Arizona Heart Institute in Phoenix, Arizona, explains, One of the major advantages of the new Frontrunner catheter platform is its reduction in size. The smaller Frontrunner now handles more like a guide wire as it pertains to delivery and comformability when moving through an artery. This smaller size, along with the blunt micro-dissection technology and the recent approval of the new drug-eluting stents, now gives physicians another opportunity to treat CTO patients that may not have been candidates for percutaneous interventions. After over one year on the market, the LuMend Frontrunner CTO Catheter has accumulated an impressive safety record. Current data reflects an extremely low reported perforation rate based on company-submitted Medical Device Reports (MDRs). These results show that for every 100 Frontrunners shipped, device-related perforation rates are reported at a 0.33% rate. Company bench testing shows that a standard guide wire (.014) may actually cause perforations at lower force levels compared to the Frontrunner. These differences in perforation force are likely related to key differences in both the distal tip design as well as how the devices are used to cross CTOs. A guide wire relies on a combination of torque and axial push to cross a CTO; in contrast, the Frontrunner relies more on the action of blunt micro-dissection. As a result, the smaller tip on a guide wire may perforate a vessel more easily than the larger, blunt tip of the Frontrunner. This is supported by company bench testing, which shows that a constrained .014- guide wire perforates tissue with 50-66% less axial force than the Frontrunner CTO Catheter. For more information, visit www.lumend.com. Start of Phase IIb Clinical Study in Intermittent Claudication Nissan Chemical America Corporation (NCA), a subsidiary of Nissan Chemical Industries, Ltd., announced that patient screening has begun for a Phase IIb clinical study of NM-702 for the treatment of intermittent claudication at multiple sites across the United States. NM-702 is a novel, orally active, phosphodiesterase inhibitor with beneficial effects on vasodilation, smooth muscle relaxation and platelet aggregation inhibition. The clinical sites for this study will enroll up to 390 male or female patients, 50 years of age of older, who present with chronic, symptomatic, intermittent claudication from inadequate perfusion due to impaired peripheral blood flow in order to achieve the study primary analysis goal of assessment of improved peak walking time. The study is being conducted by Catalyst Pharmaceutical Research LLC (Catalyst). There are an estimated 5.6 million individuals in the United States and a comparable number in Europe with IC. It is estimated that less than 10 percent of these individuals are receiving active medical care for their IC. Research Reveals Women's HeartAdvantage is Improving the Heart Health of American Women The Number of Women Who Completed a Heart Risk Assessment has Nearly Doubled VHA Inc. says its Women’s HeartAdvantage program has had a measurable impact on the heart health of American women. By combining community awareness initiatives with physician and clinician training, Women’s HeartAdvantage is attacking this deadly disease from all angles. One year after initiating the Women’s HeartAdvantage program, Yale-New Haven Hospital in New Haven, Conn., revealed dramatic improvements in women’s awareness of heart disease. 47 percent of women now recognize heart disease as their gender's greatest health threat, an increase of more than 80 percent from initial benchmarking. 70 percent of women now know and can identify that men and women may experience different symptoms of a heart attack, as opposed to only 48 percent. The number of women who completed a heart risk assessment nearly doubled, from 33 women out of the 300 surveyed in 2000 to 63 women in 2003. Approximately 300 women participated in the survey by Yale-New Haven Hospital in the New Haven, Conn. community. VHA’s Women’s Heart Advantage program is one of a few national programs to finally wake up women to their number-one-leading killer. But what makes this approach unique is that it arms women with effective tools about risk assessment, and teaches them to recognize symptoms so they can respond quickly should a heart attack occur, said Dr. Bairey-Merz, Women’s HeartAdvantage national spokesperson and cardiologist from Cedars-Sinai Health System in Los Angeles. This program distinctively links both consumer awareness with physician education to encourage better heart health outcomes for women. VHA is collaborating with more than 100 hospitals across the nation to implement Women’s Heart Advantage. The program strives to improve cardiovascular health and quality of life through the prevention, detection and treatment of risk factors; early identification and treatment of heart attacks; and prevention of recurrent cardiovascular events in women. The program is intended to raise awareness and change behavior among women by encouraging steps to prevent heart attacks and teaching how to recognize when a heart attack is occurring, since the symptoms for women are often different from those in men. The program improves clinical outcomes for heart attack patients by outlining specific treatment guidelines. Those guidelines include the administration of aspirin, blood thinners, beta-blockers and ACE inhibitors within 24 hours. Before implementing the Women’s HeartAdvantage program, each VHA hospital conducts benchmarking research to assess the awareness and attitudes about heart disease among women in the community. The results have shown a significant failure by women to recognize heart disease as their greatest health threat. For example, Memorial Hermann Healthcare System in Houston discovered only 28 percent of the women in their community recognized heart disease as their greatest health concern. Women fear cancer more than heart disease and believe it is the most likely cause of their untimely death. This is a dangerous misconception that must be addressed by the health care industry, said Dr. Bairey-Merz. Most women are simply not aware that heart disease kills more women each year than the next seven causes of death combined. Beginning with its national launch in 2002, the Women’s HeartAdvantage program began changing those statistics in communities across the country, through a targeted campaign that reaches women and medical personnel on multiple levels. To date it is estimated less than 30 percent of women have talked with their doctor about the risk factors of heart disease. However, VHA and Women’s HeartAdvantage are working to improve those numbers. Along with consumer education encouraging women to talk to their doctors, the Women’s HeartAdvantage program provides training and tools to all doctors to facilitate communication and to improve their ability to identify, prevent and treat this killer disease. Women’s Heart Advantage includes materials for non-typical health care providers, such as OB-GYNs and emergency medical personnel. The five hospitals launching Women’s Heart Advantage include: Sparks Regional, Fort Smith, Ark. Floyd Memorial Hospital and Health System, New Albany, Ind. Bryan LGH, Lincoln, Neb. Carolinas Healthcare System, Charlotte, N.C. The Queen's Medical Center, Honolulu, Hawaii It is imperative to educate everyone, including health care professionals, that women often do not experience the ‘Hollywood’ heart attack. A woman’s heart attack often involves atypical symptoms, such as sweating or apparent indigestion, not simply chest and shoulder pain, said Dr. Bairey-Merz. Supplemented Formula Helps Blood Pressure Children fed formula supplemented with long chain polyunsaturated fatty acids have significantly lower blood pressure than those given unsupplemented formula. In fact, it’s about as low as that of children who were fed mother’s milk, European researchers report. It is the latest claim to be made for such supplementation, which has been said to improve either vision or intelligence or both. And the new claim is made on the basis of a carefully controlled study backed by a scientific theory. Nevertheless, it is drawing a wary response from at least one pediatrician. The study was done at four European centers. At 6 years of age, the 71 children given the supplemented formula had blood pressure readings 3 millimeters lower than those of the 76 children in the unsupplemented group. And the supplemented group’s readings were about the same as that of 88 children who were breast-fed. The result is important because blood pressure does appear to track from childhood into adulthood, says study author Dr. J. Stewart Forsyth, a consultant pediatrician at the Tayside Institute of Child Health in Dundee, Scotland. The theory is that the long chain polyunsaturated acids are absorbed in the cells of the endothelium, the delicate tissue that lines the blood vessels, Forsyth says, making them less vulnerable to the fatty deposits that eventually can block a blood vessel. Until recently, it was assumed that infants were able to make these long chain fatty acids from short-chain fatty acids in formula, Forsyth says. Newer research shows that is not so, he says. But the study results may not be as convincing as they seem, says Dr. Michael Wasserman, a pediatrician at Ochsner for Children, a New Orleans branch of the Ochsner Clinic. There was a high dropout rate in the study, with only about 40 percent of the children who enrolled at the start completing it, he says, and there were differences between the groups that might cloud the results. But the main reason for skepticism is that high blood pressure is a multidimensional condition influenced by many factors, Wasserman says. You can’t look at development of high blood pressure so simplistically. It is multidimensional in ways we don't understand. Diet is one dimension, Wasserman says, but you are looking at a big pie. We don't know how big a slice of the pie this is. The question of using a supplemented formula comes up constantly in his pediatric practice, Wasserman says, because some formula makers advertise the benefits of the supplements. When he is asked, he says, it probably does no harm and probably does some good. The gold standard of nutrition early in life is breast-feeding, says the American Academy of Pediatrics, and Forsyth and Wasserman agree. etrials Technology Used in REPLACE-2 for Paperless Acute Care Clinical Trial etrials Worldwide, Inc., a provider of eClinical software for the collection, integration and review of data in the clinical trial process, announced that REPLACE-2, a clinical trial of The Medicines Company’s Angiomax® (bivalirudin), exclusively employed etrials’ Web-based data capture system, making it the largest paperless clinical trial ever completed by etrials. All of the 233 clinical trial sites in the U.S., Canada, Western Europe and Israel employed a real-time data entry system that was Web-based and included etrials’ QuickStudy Capture electronic data capture (EDC) technology and QuickStudy Touch services. The data in REPLACE-2 was collected and entered rapidly, as the enrollment of more than 6,000 patients was completed in less than one year. Following the completion of target enrollment and 30-day patient follow-up in late September of 2002, the trial organizers were able to complete data entry, lock the database, adjudicate and clean the data, and finally prepare the data for a late-breaking presentation at The American Heart Association’s Scientific Sessions 2002. The study data included 498 questions, or over three million data points and more than 500 edit checks. The process of final data collection and adjudication, which usually takes a matter of months, was completed in just three and one-half weeks with etrials’ assistance. With etrials’ technology and support, The Medicines Company was able to transition from traditional paper-based data collection processes to electronic systems. In addition to creating the electronic case report forms (CRF), programming the validation or edit checks and setting up the custom reports, etrials provided training and project management services. etrials’ EDC technology is supported by a team of clinical specialists who work closely with customers to maintain data quality and security. OmniSonics Medical Technologies: Initial Results Demonstrate Effectiveness of Novel Acoustic Energy Device in Resolving Occlusions in Coronary Arteries OmniSonics Medical Technologies, developer of products based on the OmniWave Technology platform to treat vascular occlusive disease, announced initial results of preclinical studies of the Resolution® System to treat occlusions in coronary arteries. This data was showcased at the Society for Cardiac Angiography and Interventions (SCAI) 26th Annual Scientific Sessions, held May 7-10 in Boston. Dr. Sung Choi, of Tufts-New England Medical Center, tested the feasibility and safety of OmniSonics’ ultrasonic technology to resolve blockages in the coronary arteries of swine. The results from initial studies in animals indicate that the technology may be effective for thrombus resolution during coronary interventions. OmniSonics is developing an acoustic technology to treat vascular occlusions. Based on the OmniWave Technology platform, the Resolution System is designed to resolve occlusions which occur as a result of coronary artery disease, hemodialysis access grafts, deep vein thrombosis and peripheral artery disease. The device, consisting of a thin, titanium wire that is placed into a clogged artery or vein, delivers low power, acoustic energy in all directions to resolve blood clots into minute particles approximately the size of red blood cells. The poster presentation was entitled, Preclinical Feasibility and Acute Safety of a Transverse Cavitation Ultrasonic Guidewire for Intracoronary Ablation of Thrombus. The Resolution System has been designed to work alone or in conjunction with existing interventional approaches including balloon angioplasty, stent placement and pharmaceutical treatments. The Resolution System has received CE Mark approval and is the subject of ongoing clinical trials in the United States. Patients Don’t Heed Heart Warnings, Study Finds Giving patients an electronic snapshot of early heart disease may not convince them to take healthy living steps to prevent things from getting worse, researchers reported. Doctors at Walter Reed Army Medical Center in Washington said they reached the conclusion after a study involving 450 Army men and women aged 39 to 45, some of whom were given electron beam tomography, a scan of the heart and blood vessels that can detect calcium deposits in the coronary arteries. None of those in the study had overt symptoms indicating heart problems. After one year, those who had the test and were given visible evidence in picture form of the extent of early calcium buildup had not changed diet or other lifestyle behavior any more than those who underwent traditional exams, said the study. The findings show the electronic scan does not substantially affect coronary risk profile. We measured change in modifiable behaviors at one year, a reasonable period after attempting to activate a patient to change lifestyle. Philip Greenland, a physician at Northwestern University, said the report showed it takes more than test results to motivate patients. Despite well-defined strategies for reducing (heart disease) risk factors, clinicians find that many patients at risk appear to lack the interest or motivation to undertake intensive risk factor treatment efforts, he said. Awareness studies show that even now large proportions of Americans have never had risk factors measured, and many who have had these measured do not achieve acceptable levels of control, he added. What it may take, he suggested, is intensive management on a case-by-case basis. High Blood Pressure More Common in Europe than N. America, Says Study High blood pressure is 60 percent more prevalent in Europe than North America, a study said. A comparison of eight national surveys conducted in the 1990s showed that the condition was much more common in European nations than in the United States or Canada, with the highest rates seen in Germany and the lowest in the United States. The six European nations surveyed had a combined prevalence of 44 percent versus North America's 28 percent, according to the study. The hypertension rates (defined as a blood pressure reading of 140 over 90) were closely correlated with fatal strokes, and less so with cardiovascular disease. Researchers at Loyola University Stritch School of Medicine in Maywood, Illinois, who crunched the numbers, did not examine the reasons for the striking differences, but speculated that more aggressive treatment of the condition this side of the Atlantic and dietary differences might explain the disparity. The European diet is higher in sodium and lower in fruits and vegetables, particularly northern Europe, said Richard Cooper, co-author of the study and chairman of Loyola University's department of preventative medicine. Stateside, the medical community’s aggressive and early treatment of the condition is thought to have contributed to a 16 percent decline in hypertension in the United States in the last 20 years. The United States and Canada have the lowest stroke rates in the world, in part because of low blood pressure in the general population, according to background information in the study. The potential for both prevention and better pharmacologic control would thus appear to be substantial for Europe, the authors wrote. These observations underscore that BP control is central to the prevention of the cardiovascular complications of hypertension, especially stroke, concluded a group of experts from the University of Leuven, in Belgium.

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