Boston Scientific (NYSE:BSX) yesterday said the FDA approved its Blazer OI ablation catheter, marking the 1st time the medical device maker will put an open-irrigated catheter for treating Type I atrial flutter on the U.S. market.
The company also said it won CE Mark approval in the European Union for the IntellaTip MiFi OI catheter for use in all cardiac ablation procedures.
“These approvals attest to our continued focus and expansion in the electrophysiology space,” cardiac rhythm management chief medical officer Dr. Kenneth Stein said in prepared remarks. “The Blazer and IntellaTip MiFi open-irrigated catheters provide electrophysiologists with technology that leverages our established platforms to help improve the health of patients around the world.”
“Successful results from the Block-CTI trial demonstrate that the Blazer open-irrigated catheter is safe and effective for the ablation of atrial flutter,” added principal investigator Dr. Tom McElderry, of the University of Alabama at Birmingham. “This newly approved ablation tool was built on the proven Blazer platform of therapeutic catheters and facilitates excellent maneuverability, consistent cooling and stability during procedures.”
Last month, Marlborough, Mass.-based Boston Scientific said co-founder & chairman Peter Nicholas plans to step down a year ahead of schedule.
