St. Jude eyes FDA approval with trial for stroke-stopping heart plug

St. Jude Medical is launching a pivotal trial for its Amplatzer Cardiac Plug.--Courtesy of St. Jude Medical

While Boston Scientific ($BSX) makes headlines with Watchman, St. Jude Medical ($STJ) is working on a stroke-preventing heart implant of its own, launching a pivotal trial for the Amplatzer Cardiac Plug.

St. Jude recorded its first U.S. implant of the device, designed to prevent blood clots from pumping out of the left atrial appendage and causing strokes in patients with atrial fibrillation. The pivotal trial will enroll up to 3,000 patients in the U.S. and Canada, St. Jude says, comparing the plug to blood-thinning drugs in safety and ability to prevent stroke.

The device has been CE marked since 2008, and St. Jude believes it can amass enough data to prove the plug bests standard-of-care warfarin therapy and get it FDA approved, Cardiovascular President Frank Callaghan said.

"The ACP trial is another example of significant investment by St. Jude Medical to develop landmark clinical evidence," Callaghan said in a statement. "This trial will help us understand the long-term benefits of (left atrial appendage) occlusion therapy for lowering the risk of stroke in atrial fibrillation patients and potentially improve their quality of life."

St. Jude is behind Boston Scientific in line for an FDA nod, as Watchman has already amassed data from its pivotal study and is likely to wind up on the U.S. market before the Amplatzer Cardiac Plug, but that won't matter too much in the long term if St. Jude's device is considerably more effective.

Boston Scientific is due to spill the efficacy beans on Watchman at this weekend's American College of Cardiology meeting in San Francisco, and while the company maintains public confidence in its device, an earlier hiccup in scheduling has market-watchers wondering whether Watchman's latest data is less than stellar. 

- read St. Jude's announcement