Boston Scientific wins FDA nods for electrophysiology tech

Boston Scientific won FDA approval for its IntellaTip MiFi XP ablation catheter.--Courtesy of Boston Scientific

Boston Scientific's ($BSX) deep dive into electrophysiology beared some good news, as the device giant picked up two FDA go-aheads for technologies it hopes will boost its flagging cardiac sales.

The IntellaTip MiFi XP ablation catheter won FDA approval, now indicated to treat atrial flutter in the U.S., and the Zurpaz steerable sheath won agency clearance, giving Boston Scientific a next-generation catheter-placement device to pair with its latest offering. IntellaTip is designed to blast localized electrical energy into cardiac tissue to treat irregular heartbeats, and the device is outfitted with electrodes on its tip that allow physicians to map heart tissue and diagnose arrhythmia.

That makes three regulatory victories in the past three months for Boston Scientific's surging electrophysiology business, following May's FDA clearance for Rhythmia, a 3-D mapping system used in electrophysiology procedures that the company acquired in its $90 million buyout of Rhythmia Medical last year.

And Boston Scientific isn't stopping there. In June, it agreed to buy rival C.R. Bard's ($BCR) electrophysiology business for $275 million, eyeing a segment that pulled in $111 million in sales last year with its line of cardiac catheter ablation devices, recording systems and mapping tools in a deal CEO Mike Mahoney said would "meaningfully advance our position in this fast-growing market."

That's just what the on-the-rebound device magnate needs. Last quarter, the company's rhythm management segment dipped another 3% to $511 million, as pacemaker and defibrillator sales dropped 3% to $475 million and its fledgling electrophysiology business pitched in just $37 million.

But with IntellaTip soon to hit the U.S. market and the Bard deal expected to close this year, Boston Scientific figures it can get a lot more than that out of electrophysiology. The global market sits at about $2.5 billion, the company figures, and it's growing at a double-digit clip.

Boston Scientific is not alone in its ambition to cash in on the burgeoning space: This week, competitor St. Jude Medical ($STJ) snapped up Switzerland's Endosense in a deal worth up to $331 million to get its hands on the TactiCath cardiac ablation catheter.

- read Boston Scientific's announcement

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