NATICK, Mass. (AP) – Boston Scientific Corp. said it will resume selling two implantable heart defibrillators that were pulled from the market in March.
The company said the Food and Drug Administration cleared two manufacturing changes to the Cognis and Teligen implants, which treat irregular heartbeats by delivering electric shocks to the heart. Boston Scientific pulled all its defibrillator implants off the market a month ago because it had failed to notify regulators of changes in the way it makes the devices.
Cognis and Teligen bring in almost all of Boston Scientific’s implantable-defibrillator revenue in the U.S. The company says it will be able to meet customer demand within 24 hours. The suspension of sales and the recall did not affect other markets.
If a medical device company makes significant changes to a life-sustaining device, it must tell regulators within 10 days.
Teligen is an implantable cardioverter defibrillator, which is designed to shock the heart to restore a regular heartbeat. Cognis has a defibrillator and contains a second component called a resynchronization device, which is designed to coordinate the pumping action of the heart.
The company, which is based in Natick, said it found other instances in which it did not submit appropriate documentation for manufacturing changes for older devices. It said it has now reported those changes to the FDA, and hopes to bring other devices back to the market. The changes involve the Confient, Livian, Prizm, Renewal, and Vitality devices.
Boston Scientific gets about 15 percent of its revenue from defibrillator sales. The company has not detailed how the suspension and recall could affect its profit and sales for the year. Boston Scientific said there could be a significant impact on its sales, and plans to give an update when it reports its first-quarter results, which are due after the close of trading on April 26.
Its defibrillator business has had a string of problems over the last four years, including safety warnings and multiple product recalls. Boston Scientific entered the business in 2006 by buying Guidant Corp. for $27 billion.
Earlier in April, the Guidant division agreed to plead guilty to two misdemeanor charges it failed to inform regulators about changes to heart devices that were prone to short circuiting. The plea deal calls for Boston Scientific to pay $296 million in penalties. That case centers on problems discovered in 2002 and 2004 with the Ventak Prizm 2 and Contak Renewal 1 and 2 defibrillators.
Boston Scientific shares rose 38 cents, or 5.3 percent, to $7.52 in aftermarket trading. The stock closed at $7.14 Thursday and is down 7 percent since the company suspended sales of the heart devices.
Date: April 15, 2010
Source: Associated Press