Boston Scientific wins FDA nod for Rhythmia cardiac mapping and ablation catheters

Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for a pair of ablation catheters that use the 3D cardiac mapping technology it bought from Rhythmia Medical back in 2012.

Marlborough, Mass.-based Boston Scientific said the federal safety watchdog gave the green light to its IntellaNav XP and IntellaNav MiFi XP mapping and ablation catheters for treating Type I atrial flutter.

Boston Scientific put $90 million in cash into the Rhythmia Medical buyout, plus another $175 million in milestones. The Rhythmia tech won CE Mark approval in the European Union in May 2013.

Today the company touted the IntellaNav devices as its 1st magnetically-tracked catheters to hit the U.S. market. In addition to their “immediate” launch, Boston Scientific said it’s also releasing a software update for the Rhythmia system.

“By combining these new magnetic navigation-enabled catheters with our high-density, high-resolution Rhythmia mapping system, we can create enhanced maps that help diagnose arrhythmias and improve guidance during cardiac ablation procedures,” rhythm management chief medical officer Dr. Kenneth Stein said in prepared remarks. “With these approvals, we continue the expansion of our electrophysiology product offerings, further demonstrating our commitment to help electrophysiologists provide the highest quality of care for their patients.”

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