Boston Scientific eyes a-fib indication for catheter

Boston Scientific is studying whether its Blazer catheter can treat atrial fibrillation--courtesy of Boston Scientific

Boston Scientific ($BSX) is kicking off a large-scale trial of its Blazer ablation catheter in patients with paroxysmal atrial fibrillation, looking to support a future FDA application to get the device indicated to treat the disorder.

The company is operating a 472-patient trial at 33 sites around the world, testing whether its open-irrigated catheter can normalize irregular heartbeats through pulses of localized electrical energy. Blazer is equipped with Boston Sci's Total Tip Cooling technology, an enhancement the company says keeps the device's electrode from overheating during radiofrequency energy delivery.

Blazer is already approved in CE mark countries, and getting FDA approval would provide a big boost to Boston Sci's cardiac rhythm management unit, CRM president Joe Fitzgerald said in a statement. "Launching this trial highlights our continued commitment to clinicians and patients through the expansion of our electrophysiology ablation business, including the high-growth segment of complex ablations," Fitzgerald said.

The company estimates the world electrophysiology market at about $2.5 billion, and, considering Boston Sci's slumping heart device business, another on-the-market device would certainly help. Last quarter, the company's CRM unit continued its slide, with revenue dropping 8% on the whole and electrophysiology slipping 2%.

But new CEO Mike Mahoney continues to aver that Boston Sci is poised for a marked turnaround this year, due to broad cost-cutting and a fleet of new and rejiggered devices. Since Mahoney took the reins in October, Boston Sci has filed for approvals around the world for innovative techs and spent $425 million to break into the hype-heavy renal denervation market with a buyout of 2012 Fierce 15 winner Vessix Vascular.

- read the announcement