WATCHMAN

Boston Scientific ($BSX) CEO Michael Mahoney predicts a long-awaited return to growth for the company in the second half of 2013, driven largely by five new products acquired through acquisitions. And Watchman may have the biggest expectations behind it of the bunch.

"Watchman is one of the most clinically tested devices ever, prior to FDA approval," Mahoney told Bloomberg. "We feel like with the body of evidence we have, this deserves to be approved."

As Bloomberg reports, the implant designed to prevent strokes in atrial fibrillation patients has wowed researchers once again, unexpectedly boosting survival in patients after four years. That's great news as Boston Scientific gears up to file its FDA approval application by the end of May. As many companies do, Boston Scientific saved its latest attention-getting data for this year's Heart Rhythm Society gathering in Denver. And the results were stunning, showing that patients with the device saw their risk of a stroke, clot or death become 40% less likely than patients treated with the current standard of care warfarin, according to the story.

The product is already on sale in Europe, and now Boston Scientific hopes to gain approval in the U.S. by the 2014 first quarter, according to the company.

Earlier this year, there was a sound of alarm when Boston Scientific hesitated to release all of its Prevail study results at March's American College of Cardiology meeting in San Francisco, spurring analyst rumors that the technology hadn't measured up to huge expectations. The company relented and showed that the implant success rate in the Prevail trial was much more than in the earlier Protect AF trial, quieting concerns.

And now those expectations are even greater. Mahoney told Bloomberg that the latest study results may help Watchman become the centerpiece of a $500 million market. And as the company confronts its third year of plunging demand and price declines for its bread-and-butter cardiac devices, Watchman could help make, or break, Boston Scientific in the long term.

POSTED BY: Steven Almany M.D.