Boston Scientific to Begin Selling Defibrillators Again

Boston Scientific Corp. will resume selling two implantable heart defibrillators that were pulled from the market in March.

The U.S. Food and Drug Administration (FDA) cleared two manufacturing changes to the Cognis and Teligen implants, which treat irregular heartbeats by delivering electric shocks to the heart. The company took 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. Medical device companies are required to inform the FDA immediately regarding significant changes to the design and/or manufacture of life-sustaining devices.

“We are very pleased that the FDA has cleared the manufacturing changes,” Ray Elliott, the company’s president and chief executive, said in a statement. “We are committed to doing the right thing every time, and we acted voluntarily, swiftly and appropriately to ensure compliance with all regulatory requirements.”

Cognis and Teligen account for nearly all of Boston Scientific’s implantable defibrillator revenue in the United States. Company officials claimed that the firm would be able to meet customer demand within 24 hours. The suspension of sales and the recall did not affect other markets.

Boston Scientific’s business has had a string of problems over the last four years, including safety warnings and multiple product recalls. The company entered the business in 2006 through the acquisition of Guidant Corp. for $27 billion.

Teligen is an implantable cardioverter defibrillator that is designed to shock the heart to restore a regular heartbeat. Cognis has a defibrillator and contains a second component called a resynchronization device that is designed to coordinate the pumping action of the heart.

The Natick, Mass.-based firm reported finding other instances in which it did not submit appropriate documentation for manufacturing changes for older devices. Those changes now have been reported to the FDA, according to company officials. The changes involve the Confient, Livian, Prizm, Renewal, and Vitality devices. In a press release dated 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.

“Boston Scientific’s reputation has been damaged, but not destroyed, by the recall,” Derrick Sung, a New York, N.Y.-based analyst at Sanford C. Bernstein & Co., said in an e-mail to investors on April 14. “It appears that it will remain a viable competitor in the market.”

This move will restart the sale of products that brought in $1.79 billion, or 22 percent, of Boston Scientific revenue in 2009.The firm has not yet 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 (ended March 31), which are due after the close of trading on April 26.