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August 9, 2023

Boston Scientific receives new FDA approval for abnormal heartbeat treatment

A building with blue tinted windows sits behind a patio with chairs and umbrellas. Photo | Courtesy Boston Scientific Boston Scientific headquarters, Marlborough

Marlborough-based biotechnology and manufacturing firm Boston Scientific has received U.S. Food and Drug Administration approval for a new catheter system for patients with atrial fibrillation, which is a type of abnormal heartbeat.

The POLARx Cryoablation System is a minimally invasive balloon catheter delivering cryotherapy to problematic venous tissue, which blocks the irregular signals to the heart. The new system from Boston Scientific addresses issues with previously available cryoablation systems, according to a Tuesday press release from the company. 

The newly approved system allows physicians to specifically fit patients with an anatomically appropriate POLARx FIT catheter. It is intended to help mitigate the need for device changeouts. It additionally can better target a wider variety of abnormal lesions in the tissue.

A clinical trial of 385 patients with paroxysmal atrial fibrillation determined the safety of the device for U.S. market standards, according to the press release. Some 25,000 patients have used the POLARx Cryoablation System worldwide. It has already received approval in Europe, Japan, and Canada.

“The new POLARx Cryoablation System, and the expandable cryoballoon catheter specifically, is an exciting development for the effective treatment of AF as it allows physicians to better tailor care for individual patients without sacrificing safety or efficiency," Dr. Wilber Su, director of electrophysiology at Banner University in Phoenix, said in the Boston Scientific press release.

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