The U.S. Food and Drug Administration cleared Boston Scientific Corp.'s manufacturing changes for its defibrillators Thursday, allowing the company to resume U.S. shipments, according to a Boston Scientific release.

The company voluntarily recalled its Cognis and Teligen defibrillators March 15 after discovering it did not follow the necessary protocol detailing that the company had added a new component supplier and reworked a cleaning process for the devices.

The FDA rejected an expedited review that would have shortened return to market before the customary 30 days. In fact, Rick Wise of Leerink Swann Research wrote in a letter to investors that the timely 30-day turnaround is encouraging.
Boston Scientific's "FDA review did not drag out any longer than the typical review period for such filings, despite the company's history of regulatory problems," he wrote.

The company is excited to be back on the market, now able to continue providing its products and services.

"We are pleased that the FDA has cleared the manufacturing changes, and that we are again able to offer Cognis and Teligen to U.S. patients and physicians," said Ray Elliott, president and CEO of Boston Scientific, in a statement.

During the 30 days when Boston Scientific was out of the defibrillator market, analysts estimated the company was losing $5 million a day. The withdrawal offered up the market to the company's two competitors, St. Jude Medical and Medtronic.

The long-term effects are still unknown, Wise wrote in his letter.

"Longer-term questions remain, specifically the extent to which this latest regulatory issue may have hurt [Boston Scientific's] reputation with physicians and patients," he wrote. "Our estimates already assume a gradual market share recovery, with some share - 3 percent - permanently lost to competitors."

A Majestic Research survey found that half of the electrophysiologists polled were less likely to use Boston Scientific devices in the future, its reputation having been tainted by the recall.

"[Boston Scientific] expects to be back on the market soon, and once they do get back on the market, that's when we'll see to what extent what companies [St. Jude Medical and Medtronic] made any share gains stick," Philip Legendy, director and senior medical device analyst at Majestic Research, recently told DOTmed News.

Moving forward, Boston Scientific will provide an update regarding the influence of the ship hold and product removal on its financial results with the release of its first-quarter earnings, states the company release.

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