Blazer Open-Irrigated catheter gets CE mark approval

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Boston Scientific announced on 3 May 2011 CE mark approval and first use in Europe of its Blazer Open-Irrigated catheter, the company’s latest radiofrequency ablation (RFA) catheter designed to treat a variety of arrhythmias such as atrial fibrillation, atrial flutter, ventricular tachycardia and other supraventricular tachycardias. The product is being launched this quarter in select CE Mark countries.

The Blazer Open-Irrigated catheter integrates Total Tip Cooling design with the high-performance Blazer catheter platform. Total Tip Cooling design is intended to consistently cool the entire tip electrode during radiofrequency energy delivery. This is achieved through both internal cooling and external washing of the tip electrode, which is designed to reduce coagulum at the proximal edges of the tip.

The first European procedure using the CE marked catheter was performed at the Hopital Cardiologique du Haut–Leveque in Bordeaux–Pessac, France, under the supervision of Prof. Michel Haissaguerre.

“The excellent cooling profile, coupled with the high performance Blazer platform, makes this catheter an important additional option for performing complex ablations,” said Sebastien Knecht, who performed the procedure with Frederic Sacher. “The tip temperatures were lower than conventional open-irrigated catheters during radiofrequency delivery, and the bidirectional catheter performed very well, accessing the pulmonary veins with dependable steering and tip stability.”

Atrial fibrillation affects more than 4.5 million Europeans. According to the company, cardiac ablation with an RFA catheter is increasingly becoming an option for patients who cannot tolerate anti-arrhythmic medications.

“The CE mark approval, first use and launch of the Blazer Open-Irrigated catheter in Europe are important milestones in our continued focus on advancing cardiac ablation technology,” said Hank Kucheman, executive vice president and president of Boston Scientific’s Cardiology, Rhythm, and Vascular Group.

In the USA, the Blazer Open-Irrigated catheter is an investigational device, limited by applicable law to investigational use only and not available for sale.

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