Boston Scientific Corporation (NYSE:BSX) new Watchman safety tests promising- STJ

Northern, WI 03/10/2013 (avauncer) –U.S regulators had asked for a second study of the Watchman device manufactured by Boston Scientific Corporation (NYSE:BSX). The device is designed to help in the prevention of strokes in patients suffering from an erratic heartbeat. Reports from the second study have proved that it is safer than what it was previously believed to be. The company will be seeking FDA approval for the Watchman as it is safe for use. The results were originally going to be presented at a meeting of the American College of Cardiology in San Francisco.  Boston scientific unintentionally distributed the results to its investors before it could be presented at the meeting which consequently had to be cancelled.

FDA ruling pending

The device is interwoven into the heart and is used to avoid pooling and clotting of blood in a reservoir, which is the primary reason for a stroke. Initially the procedure itself was the trigger for complications such as clots and strokes being caused in 2.2 percent patients in less than one week. Cardiologist David Holmes, the lead researcher at the Rochester, Minnesota-based Mayo Clinic said that this was an acceptable risk in lieu of helping patients to avoid the use of daily blood thinners. The safety issues have now been taken care of and the efficacy of the device has been tested which is a big step forward. He declined to predict what the FDA ruling on the device would be.

In 2009, the U.S Food and Drug Administration had requested Boston Scientific Corporation (NYSE:BSX) for a new trial as the rate of complications in the initial study had been unacceptably high. They had not approved the device then. The preliminary analysis about the efficacy of the device after an 18-month trial brought in mixed results. It did not succeed in proving how effective Watchman was in comparison to warfarin, the blood-thinner that is used to ward-off clots, strokes and death.

Controversy averted

Earlier this week, Boston Scientific created a controversy of sorts as it announced that only limited trial safety information would be submitted. The decision was subsequently reversed by the company. The study results have been funded by Boston Scientific Corporation (NYSE:BSX). Both, the Mayo Clinic and Holmes have licensed the technology to Atritech Inc and have a financial interest in it. The company officials have estimated that the market for this device that is used to block the left arterial appendage has the potential to touch $5 million within a period of five years. The device is in competition with the European Amplatzer cardiac plug manufactured by St. Jude Medical, Inc (NYSE:STJ).

Shares of Boston Scientific Corporation (NYSE:BSX) went up by 0.81% to close at $7.49

Shares of St. Jude Medical, Inc (NYSE:STJ) went up by 1.31% to close at $42.25