After several recalls of its implanted defibrillators, device maker
is trying to start anew.
Following the recent relaunch of its Contak Renewal defibrillator, Guidant said the Food and Drug Administration has approved the Vitality HE implantable cardioverter defibrillator.
According to the Indianapolis-based company, the Vitality HE has a slimmer design, but has the capacity to deliver a higher energy shock to defibrillate patients. The device is expected to reach the market in early October.
The clearance of the Vitality HE, the August return of the Contak Renewal 3 defibrillator and other recent approvals "reflect Guidant's commitment to providing physicians and patients a broad array of therapeutic options for the prevention of sudden cardiac death and the treatment of heart failure," Fred McCoy, president of Guidant's cardiac rhythm management group, said in a press release.
Shares of Guidant were up 72 cents to $68.89 Friday.
Guidant has been in the headlines for the last couple of days because an article in
The New York Times
said FDA regulators might be conducting a criminal investigation of the company as a result of some of its product missteps. The article said the FDA wouldn't confirm or deny the probe.
This past June,
Guidant issued warnings and recalls on some of its faulty defibrillators, including models of the Contak Renewal.
Johnson & Johnson
is in the process of buying Guidant for $76 a share. Representatives for Guidant, J&J and the FDA couldn't be reached for comment.