FDA clears Boston Scientific to resume some defib distribution

April 16, 2010 by MassDevice staff

The Food & Drug Administration clears recent manufacturing changes made by by Boston Scientific Corp., partially resolving a notification glitch that had idled company's top-selling defibrillator implants for the past month.

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Boston Scientific Corp. (NYSE:BSX) resumed U.S. shipments of its Cognis and Teligen defibrillators after federal regulators cleared recent changes to the company's manufacturing processes.

Boston Scientific voluntarily suspended all domestic defibrillator sales and began a recall of devices not yet implanted March 15 after discovering it had failed to submit the necessary paperwork detailing that the company had added a new component supplier and reworked a cleaning process for the devices. Both changes were fully validated, but medical device companies are required to first notify the Food & Drug Administration whenever there are a significant changes in the design or manufacture of medical implants.

Cognis and Teligen, both introduced over the past two years, now account for nearly all of Boston Scientific's defibrillator sales in the U.S. and logged roughly three-quarters of global sales for its $2.56 billion cardiac rhythm management unit during 2009, according to its most recent annual report. The Natick, Mass.-based device maker is expected to provide its first estimates of the impact of the month-long suspension on company revenues when it reports first-quarter results April 26.

Also included in the recall were the company's Livian, Confient, Prizm, Renewal and Vitality product lines. Livian and Renewal, like the Cognis defibrillators, are cardiac resynchronization therapy defibrillators, designed to treat heart failure by helping both sides of the heart contract at the same time. The other devices, along with the Teligen line, are implantable cardioverter defibrillators, which help slow dangerously fast heart rhythms in the lower chambers of the heart to restore normal heartbeats.

In a press release issued April 15, Boston Scientific officials said they were working closely with the FDA to secure clearances to return the other product lines to the U.S. market as soon as possible. The company's pacemakers and other product lines were not affected by the recent recall and shipping hold.