Boston Sci wins FDA approval of ablation catheter to treat atrial flutter

Blazer-Open Irrigated radiofrequency ablation catheter--Screenshot courtesy of Boston Scientific

Boston Scientific ($BSX) made a splash in the hot electrophysiology arena, securing FDA approval of the Blazer-Open Irrigated radiofrequency ablation catheter. It's the company's first OI catheter to hit the U.S. market.

The device is indicated to treat atrial flutter, an abnormal heart rhythm that causes the heart to beat too fast, potentially leading to congestive heart failure, heart attack or stroke. The condition is similar to, but distinct from, the more common abnormal rhythm dubbed atrial fibrillation.  

Localized electrical energy is delivered through the tip of the catheter's electrode, Boston Scientific says. The resulting heat destroys (or ablates) the offending heart tissue that's responsible for atrial flutter.

The OI catheter is integrated with a radiofrequency controller and pump that also provides procedural information like flow rate, according to a company video. Boston Scientific touts the newly approved Total Tip Cooling technology which cools the catheter tip during the ablation procedure to improve the quality of the ablation lesion.

Approval came via the FDA's stringent PMA pathway, including a trial a randomized trial consisting of 302 patients with sustained or recurrent Type 1 atrial flutter.

The news comes on the heels of Boston Scientific's CE mark for the IntellaTip MiFi OI catheter for use in all cardiac ablation procedures, not just those designed to treat atrial flutter. It is an investigational device in the U.S.

"These approvals attest to our continued focus and expansion in the electrophysiology space," said Dr. Kenneth Stein, the company's chief medical officer of cardiac rhythm management devices, in a statement. "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."

Catheters to treat abnormal heart rhythms are a high-growth area in the device world, led by Johnson & Johnson's ($JNJ) Biosense Webster and fellow bigwig St. Jude Medical ($STJ), with Medtronic ($MDT) and Abbott ($ABT) active participants as well. The devices delivered Boston Scientific $233 million in annual revenue last year, up 2% (or 9% when adjusting for exchange rate fluctuations). 

- read the release

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