Continued Improvement and Outstanding Safety
Seen with Boston Scientific's FilterWire
EZ™
Embolic Protection System
Data shows second-generation device reduces risk of major adverse cardiac events by half
NATICK, Mass., Oct. 17 -- Boston Scientific Corporation (NYSE: BSX - News) today announced the combined results from the BLAZE and BLAZE II(1) registries showing that its second-generation FilterWire EZ™ Embolic Protection System reduces major adverse cardiac events during and after stent placement in patients with blockages in saphenous vein grafts (SVG) after coronary artery bypass graft (CABG) surgery. The results from the BLAZE registries were presented at the Transcatheter Cardiovascular Therapeutics symposium, in Washington, D.C.
SVGs are commonly used to bypass blocked coronary arteries. As many as one-third
of patients experience significant blockages in the grafted vessel(s) within
12 years following CABG surgery and, as a result, must undergo balloon angioplasty
or stenting. However, these procedures can cause small particles of the blockage
to dislodge and migrate into small coronary arteries, impeding blood flow (distal
embolization) and causing heart attacks.
"Stenting SVG's is challenging, given the risk of embolization associated with adverse cardiac events and SVG anatomy is often deceptively complex," said David Cox, M.D., principal investigator in the BLAZE II study. "With previous embolic protection systems, we consistently saw a 10 percent incidence of adverse cardiac events associated with stenting. FilterWire EZ appears to reduce this risk, while making it easier to navigate through complex graft anatomy over a wide range of diameters."
The BLAZE and BLAZE II registries were designed to evaluate the rate of major adverse cardiac events following percutaneous intervention procedures using two different versions of the FilterWire EZ™ Embolic Protection System, one for SVG vessels with a diameter of 3.5 mm to 5.5 mm, and one for SVG vessels with a diameter of 2.25 mm to 3.5 mm. A total of 221 patients with clinically significant lesions in previously grafted saphenous vessels were evaluated in the two prospective, multicenter registries.
The primary endpoint for both registries was the incidence of major adverse cardiac events (MACE), including myocardial infarction (MI), target vessel revascularization (TVR) and death, during the 30 days following the procedure. Composite data from the BLAZE registries demonstrated a 98.1 percent rate of procedural success. MACE at 30 days occurred in 5.0 percent of patients.
"Boston Scientific is committed to patient safety, and we are pleased to provide clinicians with a safe, effective, user-friendly means of protecting diseased SVGs," said Milton McColl, President of Boston Scientific's Neurovascular Division. "The addition of new device sizes will make the FilterWire EZ System applicable to more lesions. We will continue to improve the technology to benefit this important patient population."
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, which would otherwise travel into the microvasculature where it could cause a heart attack. The FilterWire EZ Embolic Protection System is also part of the BEACH clinical trial for use in the carotid vasculature. It is considered an investigational device for this use and limited by U.S. law to investigational use by qualified investigators only. Pending PMA approval and 510(k) clearance respectively. Not available for sale in the United States. 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 followed by the launch of the FilterWire EZ™ System in August 2004.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
This press release contains forward-looking statements. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
(1) The BLAZE II registry studied FilterWire EZ (2.25 mm - 3.5 mm) Embolic
Protection System. Pending 510(k); not available for sale in the United
States.
CONTACT:
Milan Kofol
508-650-8569
Investor Relations
Boston Scientific Corporation
Paul Donovan
508-650-8541
Media Relations
Boston Scientific Corporation
Source: Boston Scientific Corporation
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