Boston Scientific kicks off trial for next-gen pacer leads

Boston Scientific is starting a trial of next-gen leads desigend for the Ingenio pacemaker--courtesy of Boston Scientific

Remember all that talk about how St. Jude Medical's ($STJ) misfortune could open up market share for Boston Scientific ($BSX)? Well, the Natick, MA, devicemaker is starting a trial for a next-gen lead that, if approved, could usher in some much-needed cardiac revenue as its competitor falters.

Boston Sci has implanted its first patient with an Ingevity pacing lead in a multi-center trial to determine safety and effectiveness and, eventually, support FDA and CE mark applications. Ingevity is designed to be more reliable and maneuverable than any pacer lead on the market, Boston Sci says, and the devices are MRI-safe, responding to growing concern in the field.

The company expects to enroll about 1,000 patients at 100 centers across 16 countries, and the leads are designed to work with Boston Sci's Ingenio pacemakers.

"Our research and development efforts focus on consistency, repeatability and industry-leading reliability," Kenneth Stein, chief medical officer of the Cardiac Rhythm Management unit, said in a statement. "We believe Ingevity reflects all of these design principles, with the goal of improving the quality of patient care across the globe."

And while Boston Sci is a ways off from commercializing the new leads, the door is open for some big gains, one analyst has said. Citi's Matthew Dodds projects that, as St. Jude continues to struggle with bad press for its Durata leads, Boston Sci could claim about 41%, or $338 million, of St. Jude's lead sales.

That kind of jump would make new Boston Sci CEO Mike Mahoney look prophetic. The company's CRM sales dropped dropped 8% in the last quarter, but Mahoney continues to tell anyone who'll listen that his company will return to revenue growth in 2013. If St. Jude's fortune worsens--and if last month's $425 million buyout of 2012 Fierce 15 winner Vessix Vascular pans out--he might just be right.

- read Boston Sci's release