Clinical and Industry News

Boston Scientific Announces FDA Clearance for Peripheral Cutting Balloon Microsurgical Dilatation Devices

Device Dilates Lesions at Lower Pressures than Traditional Angioplasty

Boston Scientific Corporation has received clearance from the U.S. Food and Drug Administration (FDA) to market its Peripheral Cutting Balloon microsurgical dilatation device in the United States. The Company will launch the device immediately.

The Peripheral Cutting Balloon device features tiny, longitudinally mounted atherotomes (microsurgical blades) on the surface of an angioplasty balloon and will be used to treat patients who are currently undergoing hemodialysis for End Stage Renal Disease (ESRD). A form of kidney disease, ESRD occurs when both kidneys are impaired or functioning at less than 10 percent of their normal rate.

Reliable access to the bloodstream three or more times a week is required to perform hemodialysis. This access must be created either through an arteriovenous fistula or via a graft, which involves connecting a soft, synthetic tube from the end of an artery to the end of a vein. The Peripheral Cutting Balloon device has been cleared by the FDA to treat patients with the second type of access point: the graft. Because of the need for repeated needle sticks during hemodialysis treatments, these access points are prone to stenosis. In order to treat such stenosis, clinicians have traditionally used percutaneous transluminal angioplasty (PTA). However, in many cases the high inflation pressure associated with PTA can put unwanted pressure on the vessel wall. The Peripheral Cutting Balloon device provides an option to conventional angioplasty because it reduces this type of trauma on the vessel. As the balloon is expanded, the atherotomes score the lesion with precise incisions, allowing the balloon to dilate the vessel with less pressure.

The stubborn make-up of these blockages may also pose the challenge of elastic recoil. The Peripheral Cutting Balloon device scores the lesion, disrupting the fibrotic continuity of the lesion.

The Peripheral Cutting Balloon device’s availability comes amid a growing prevalence of ESRD, which affects more than 500,000 people worldwide every year, nearly 400,000 of them in the U.S.

This device will undoubtedly have an important role in interventional medicine, particularly for the treatment of recalcitrant stenoses which are unyielding to conventional angioplasty, said Thomas Vesely, MD, of the Washington University School of Medicine in St. Louis. Because the device scores the lesion with precise incisions, it may also prevent elastic recoil in these stubborn lesions. There also appears to be a pain benefit associated with the device, as well as a six-month long-term benefit to patients with thrombosed dialysis grafts.

Boston Scientific Announces FDA Clearance for Filterwire EZ Embolic Protection System
Next-generation system cleared for SVG treatment in the U.S.

Boston Scientific Corporation has received 510(k) clearance from the U.S. Food and Drug Administration to market its FilterWire EZ Embolic Protection System to treat saphenous vein graft (SVG) disease. The Company plans to launch the product in the United States immediately. Boston Scientific launched the product in Europe and other international markets in September 2003.

The FilterWire EZ System is a low-profile embolic filter mounted on a guide wire and is designed to reduce complications during balloon angioplasty and stenting procedures for the treatment of SVG disease. The filter captures embolic material that becomes dislodged during interventions. The FilterWire EX System,Boston Scientific’s first-generation embolic protection product, was the first filter-based system cleared for SVG treatment in the U.S. and was launched in June 2003.

The FilterWire EZ system features a new suspended loop design that supports the filter, allowing for complete vessel wall apposition and for placement in both straight and curved vessels. The system is also 6F guide catheter compatible, and has enhanced deliverability with a 3.2F crossing profile.

The suspended loop design and the improved deliverability of the FilterWire EZ System have proved to be clinically important improvements, said David Cox, MD, U.S. Principal Investigator for the BLAZE clinical registry. In the BLAZE registry, the FilterWire EZ System showed improved rates of procedural success and reduced the risk of Major Adverse Cardiac Events (MACE) compared to previously studied embolic protection systems.

The FilterWire EZ System was studied in the BLAZE clinical registry, in which the objective was to establish the safety and efficacy of the FilterWire EZ System during balloon angioplasty or stenting procedures in the treatment of SVGs. The BLAZE multi-center registry studied 90 patients at 16 U.S. and six European sites. The primary safety endpoint of the study was the cumulative incidence of MACE, defined as death, Q-wave or non Q-wave myocardial infarction (MI), emergent coronary artery bypass surgery (CABG), or target vessel revascularization (TVR) at 30 days post-procedure. In the BLAZE registry, the incidence of MACE at 30 days was 6.7 percent, compared to 9.9 percent in the FIRE Trial for the FilterWire EX System.

GE Healthcare Launches Advanced Miniaturized Cardiovascular Ultrasound Technology; Visual Stethoscope of the Future

GE Healthcare announced the launch of Vivid i, a miniaturized cardiovascular ultrasound system to provide high-performance, full-featured imaging in a lightweight design.

The Vivid i is the result of new patented technology developed by GE researchers. According to Omar Ishrak, president and CEO of GE Healthcare’s Ultrasound unit, this new system will establish a completely new standard of efficiency for physicians. The mobility of Vivid i will enable physicians to deliver care to the patient wherever it’s needed. The freedom laptops and PDAs have brought to business will now be available to healthcare.

Vivid i offers the functionality and high performance of full-featured, larger-scale systems - but in a portable and wireless design that weighs 30 times less. The system makes it possible for patients to receive diagnostic exams anywhere, including bedside, as opposed being transported to an imaging lab in a hospital.

The system’s full clinical utility also makes it ideal for urgent care areas including the emergency room, critical care, and the operating room, and for mobile imaging services and outpatient clinics looking to expand their cardiovascular services.

In addition, Vivid i features wireless capabilities, enabling physicians to transfer files instantly from the system to other physicians for consultation.

GE’s engineers developed Vivid i by miniaturizing the components of a premium echocardiography system weighing more than 400 pounds (180 kilograms), to provide a portable system weighing only 10 pounds (less than five kilograms).

Professor George Sutherland, Department of Cardiology, St. George’s Hospital in London,England said, Echocardiography is about to undergo a major change. With its ease of movement and diagnostic image quality, this portable ultrasound system makes it easier for the doctor to go to the patient to perform an ultrasound scan, rather than the reverse.

GE received 510k clearances from the U.S. Food and Drug Administration and CE Marking certification for Vivid i in 2004. The system will be commercially available in fall 2004.

Medtronic Provides Details on the ENDEAVOR IV Clinical Trial
Randomized Trial to Compare Endeavor Drug Eluting Coronary Stent to TAXUS

David E. Kandzari, MD, the Co-Principal Investigator for the ENDEAVOR IV Clinical Trial, presented details on the proposed design of the ENDEAVOR IV Clinical Trial today at the European Society of Cardiology (ESC) conference. ENDEAVOR IV, sponsored by Medtronic, Inc., will be the fourth in a series of clinical studies to support global product approval of Medtronic’s investigational Endeavor Drug Eluting Coronary Stent. The ENDEAVOR IV trial will be conducted at approximately 70 sites throughout the U.S. Medtronic intends to begin ENDEAVOR IV patient enrollment in October.

The ENDEAVOR IV Clinical Trial will be a randomized, single-blind trial evaluating the safety and efficacy of the Endeavor Drug Eluting Coronary Stent as compared to the Taxus Paclitaxel-Eluting Coronary Stent System from Boston Scientific Corporation. The ENDEAVOR IV study will include approximately 900 patients randomized three to one against the Taxus stent. The primary endpoint of the trial is target vessel failure (TVF) at nine months with a secondary endpoint of major adverse cardiac events (MACE) at 30-days. The trial includes angiographic and intravascular ultrasound (IVUS) follow-up at eight months for a subset of patients. The co-principal investigators of ENDEAVOR IV are Martin B. Leon, MD, of Columbia University Hospital, New York, NY, and David E. Kandzari, MD, Duke University Medical Center, Durham, NC.

Dr. Kandzari said, Upon completion of this trial, Medtronic will have important comparative data against the Taxus stent in addition to data gathered on the Cypher stent from Johnson & Johnson in the ENDEAVOR III trial. Furthermore, this trial will provide safety data on more than 2,000 patients requested by the FDA. Finally, since the trial inclusion criteria allows for multi-vessel treatment to reflect a broad clinical population, we expect the protocol design should facilitate swift patient enrollment in the trial.

The ENDEAVOR I Clinical Trial is a 100-patient, prospective, multi-center trial studying the safety and efficacy of the Endeavor drug-eluting stent for the treatment of de novo coronary lesions in native coronary arteries. The trial began in 2003 and was conducted at sites in Australia and New Zealand. ENDEAVOR I 12-month results were presented today at ESC and at the EuroPCR conference in Paris in May.

The clinical 12-month results released include a MACE rate of 2.0 percent; a 12-month cumulative angiographic binary restenosis (ABR) rate of 5.4 percent; TLR rate of 1.0 percent; an in-segment late lumen loss of 0.43 mm and an in-stent late lumen loss of 0.61 mm.

The ENDEAVOR II Pivotal Clinical Trial completed enrollment of 1,200 patients in January 2004. ENDEAVOR II is a randomized, double-blind trial that will evaluate the safety and efficacy of the Endeavor Drug-Eluting Stent compared to the Driver cobalt alloy stent. The primary endpoint of the study is the TVF rate at nine months. Nine-month clinical results on ENDEAVOR II will be presented at the American College of Cardiology (ACC) conference in March 2005. The ENDEAVOR II Continued Access Registry completed enrollment of an additional 300 patients in July and will provide additional safety and efficacy data.

The ENDEAVOR III Clinical Trial is a randomized trial evaluating the safety and efficacy of the Endeavor Drug Eluting Stent as compared to the Cypher® Sirolimus-eluting stent marketed by Cordis Corporation, a Johnson & Johnson company. The study will enroll 436 patients (327 receiving the Endeavor stent) and has a primary endpoint of in-segment late lumen loss at eight months. Secondary endpoints include TLR, TVR, and TVF rates at nine months and angiographic binary restenosis (ABR) rate at eight months.

The Medtronic Endeavor Drug Eluting Coronary Stent system combines Medtronic’s Driver Coronary Stent, the drug ABT-578 and a PC polymer into a drug eluting stent system designed to reduce restenosis.

Diabetes Going Undetected in Many Heart Patients

Diabetes is an undetected and silent threat for many people who end up with heart disease, according to new research.Professor John McMurray, of the Western Infirmary in Glasgow, Scotland, said the problem was more widespread than previously realized, highlighting the need for more routine diabetes testing.

Of 43,500 people screened for inclusion into a major heart drug trial- of whom only 20 percent already had cardiovascular disease - approximately 1 in 5 had previously undiagnosed type 2 diabetes, McMurray told the annual meeting of the European Society of Cardiology.

And more than 1 in 4 additional subjects had impaired glucose tolerance, a pre-diabetic condition which frequently progresses to full-blown diabetes.

McMurray’s findings were based on screening of patients, with an average age of 63 years, for the Navigator study, which is backed by Novartis. It is investigating whether two Novartis drugs, Diovan and Starlix, can reduce heart attacks and stroke and prevent the onset of full diabetes in people with impaired glucose tolerance. Results from the clinical trial, which aims to enroll a total of more than 9,000 patients, are expected in 2008.

Study Challenges Common View of Ethnic Differences in Atherosclerosis

Similar prevalence of coronary calcium in blacks and whites clashes with earlier studies

In contrast to earlier studies that indicated African-Americans tend to have lower amounts of atherosclerosis than whites, despite having higher cardiovascular death rates, heart scans in a large, representative population indicate that blacks and whites have similar amounts of coronary calcium deposits, which are a sign of atherosclerotic plaques, according to a new study.

What we found was that blacks have as much coronary calcium as whites and among women there was a trend towards more. That indicates that blacks don’t have less atherosclerosis. There are other papers that went in the other direction, but we think the size of the sample in this study and the fact that it was a random population provides pretty strong evidence that there is as much atherosclerosis, said Scott M. Grundy, MD, PhD at the University of Texas Southwestern Medical Center in Dallas.

The researchers, including lead author Tulika Jain, MD, measured coronary calcium with electron beam computed tomography (EBCT) scans in 1,289 men and women. The participants were part of the Dallas Heart Study, which is a multiethnic, probability-based sample of the Dallas county population in which blacks were systematically over-sampled so the final group was 50 percent black.

Dr. Grundy said although this study indicates blacks and whites have similar rates of atherosclerosis, the study found other differences in cardiovascular risk factors.

We also found that blacks have a different pattern of risk factors for atherosclerosis and heart disease than whites do. They had more high blood pressure and more diabetes, and the black men were more likely to smoke. The whites had worse lipids. So probably on the whole, the things that cause atherosclerosis were different, but they ended up with the same amount of atherosclerosis, Dr. Grundy said.

He noted that since high blood pressure, diabetes and smoking can lead to health problems beyond just atherosclerosis, the different patterns of risk factors seen in this study may offer some potential explanations for the higher cardiovascular death rates seen among African-Americans. He said future studies should investigate how different patterns of risk factors may lead to different ultimate outcomes, including death rates.

Dr. Grundy said this study used a larger and more representative sample of people than previously published research, though there can always be questions about whether the study participants truly represent the community as a whole. He pointed out that the participants in this study were generally younger than those in other studies, which may indicate changing patterns of risk factors from one generation to the next. He also noted that coronary calcium scan results may not be a perfect indicator of the extent of atherosclerosis, but EBCT is the best noninvasive screening tool available.

Robert C. Detrano, MD, PhD, FACC at the Harbor-UCLA Medical Center in Torrance, Calif., who was not connected with this study, said, This report from the Dallas Heart Study presents evidence that conflicts with that of other large multi-center studies such as the CARDIA study and from other single center studies like the Army PACC study, the South Bay Heart Watch study and the Women's Health Initiative study. The Dallas study finds little difference in the prevalence or amount of coronary calcium in African-American and Caucasian adults. The other studies find that African-Americans have less calcification than Caucasians. This important discrepant finding needs to be placed into the context of the bulk of the literature on this subject.

Paolo Raggi, MD, FACC at the Tulane University School of Medicine in New Orleans, who also was not part of this research team, said, Nonetheless, it remains to be explained why blacks have a greater cardiovascular disease burden in the presence of the same atherosclerosis burden. To me this is another lesson in ‘humility’ as I teach my trainees all the time: ‘There is more that we do not know rather than what we do know about atherosclerosis and cardiovascular disease.’

Most Heart Attacks Easily Predictable

Virtually the entire risk of heart attack can be predicted and the impact of factors causing attacks is the same whether you live in a rich country or a poor one, a global study showed.

Results of the study of more than 29,000 people in 52 countries, released at a meeting of the European Cardiology Society, showed that two factors alone an abnormal ratio of bad to good cholesterol and smoking were responsible for two-thirds of the global risk of heart attack.

Other risk factors were high blood pressure, diabetes, abdominal obesity, stress, a lack of daily consumption of fruits and vegetables, and lack of daily exercise.

Drinking small amounts of alcohol regularly was found to reduce risk slightly.

This convincingly shows that 90 percent of the global risk of heart disease is predictable, researcher Salim Yusuf, a professor of medicine at McMaster University in Ontario, Canada, said.

This is good news. It means we can do something about it.

The findings contradict current thinking which suggests that only around half of the risk of heart disease is accounted for by known factors.

They also imply that creating awareness of heart-attack risk factors may be easier than earlier thought.

The impact of risk factors is the same in every ethnic group and every region of the world, Yusuf said, adding that this meant the message of preventing heart disease could be quite simple and fairly uniform across the world.

The study showed that smokers had a threefold risk of heart attack compared to non-smokers. Non-smokers who ate fruits and vegetables regularly, exercised three times a week and drank a little alcohol cut their risk by more than 80 percent.

Over 80 percent of heart disease occurs in low and middle-income countries but data on risk factors in these countries has so far been scanty.

Statin Therapy for Acute Coronary Syndrome May Reduce Plaque

Early cholesterol-lowering drug therapy after hospitalization for acute coronary syndrome appears to reduce arterial plaque, according to a study.

This was true even among patients who did not have very high low-density lipoprotein cholesterol levels.

This is the first evidence that plaque can regress with early statin treatment in heart attack patients, said Shinya Okazaki, MD, study researcher and an instructor in the department of cardiology at Juntendo University School of Medicine in Tokyo. This evidence provides further support for the use of statins after a heart attack.

Researchers studied 70 patients who had emergency procedures to re-open narrowed arteries after having heart attacks or unstable angina. Half of the patients received daily 20 mg doses of the cholesterol-lowering drug atorvastatin. The other half (control group) received a cholesterol-lowering diet. If their LDL cholesterol level was still very high (150 mg/dL or higher) a month later even with the diet, doctors prescribed a cholesterol absorption inhibitor.

We hypothesized that the early statin treatment would reduce artery plaque volume after a heart attack and, therefore, would decrease one’s chance of having another heart attack, Okazaki said.

Okazaki and colleagues measured each patient’s plaque volume using intracoronary ultrasound technology at the start of the study and after six months of therapy.

They found, at six months, that the LDL-C level was decreased by 41.7 percent in the atorvastatin group compared with a 0.7 percent increase in the control group.

The plaque in the vessel was reduced by an average of 13.1 percent in the atorvastatin group, but it increased by an average of 8.7 percent in the control group.

The positive effect of atorvastatin was evident whether people went into the study with an LDL-C above 125 mg/dL or not, indicating that this lipid-lowering therapy would be beneficial whether people who have heart attacks have very high cholesterol or not, Okazaki said. It could be that, when it’s given for six months immediately after heart attack, the therapy targets the vulnerable, lipid-rich plaque in the vessel.

Okazaki said early cholesterol-lowering may not only cause vulnerable plaque to regress, but might also stabilize it, although this was not assessed in this study. This could be an important way to reduce the chance of a recurrent heart attack regardless of a patient’s LDL-C level. In this small, short-term study, there were no differences in cardiac events (heart attack, cardiac death, angina, repeat angioplasty or repeat bypass surgery.)

Future studies should examine how statin therapy stabilizes plaque early after a heart attack, as well as the effects of other new LDL cholesterol-lowering drugs, he said.

New Benefit Found From ACE Inhibitor

Doctors have unravelled a new way in which an ACE inhibitor can help prevent heart attack and strokes. Research showed for the first time that the drugs not only reduce hypertension, but also help protect the lining of blood-vessel walls. Professor Roberto Ferrari of the University of Ferrara, Italy, presented the findings on perindopril, one of a number of drugs with the same mode of action, at the annual meeting of the European Society of Cardiology.

Perindopril, which is sold under the brand name Coversyl, is made by privately owned French firm Servier and is marketed by Solvay in the United States.

Researchers had demonstrated a year ago that heart patients given perindopril in addition to aspirin and cholesterol-lowering statins had a 20 percent lower risk of serious cardiac events. But Ferrari said this improvement could not be explained solely by the effect of lowering blood pressure.

In order to find out more, he and his team cultivated cells from the blood vessel wall of human umbilical cords with blood from patients in the earlier trial.

They discovered that the drug had clear benefits for the functioning of the endothelium. Scientists have long suspected ACE inhibitors can also improve blood vessel wall structure.

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