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.

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