Cath Lab Digest

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.