plans to discontinue the Ancure Endograft System product line, the treatment for abdominal aortic aneurysms that last week led to the company's settlement of 10 felony charges and the payment of millions of dollars in fines.
"We are grateful to the many physicians who relied on the Ancure Endograft System for treating patients with this serious condition," the company said in a press release. "We understand that the discontinuation of the product will involve a time of transition, which we pledge to make as smooth as possible."
Last Thursday, the Justice Department said Guidant covered up thousands of incidents in which the Ancure malfunctioned. Among those cases were 12 deaths, the government said.
As a result of problems with the device, Guidant's EndoVascular Technologies unit agreed to plead guilty to nine felony counts of shipping misbranded products and another felony count regarding a former employee who made false statements to the government.
EndoVascular said it would pay more than $90 million to the government in connection with the settlement.
The Ancure was first approved for commercial distribution in the U.S. in September 1999 before being recalled in March 2001. The device was then reintroduced in August 2001.
Guidant will ship the product and provide support to physicians who are implanting the Ancure to their patients through Oct. 1. After that, the company will continue to support patients with implants and physicians for long-term follow-up and device tracking needs. Otherwise, Guidant's EndoVascular Technologies division will stop doing business.
Most of the affected EndoVascular employees will be offered other positions at Guidant. The financial results for the Ancure product line will be reported as discontinued operations. For 2003, Guidant expects the reported total after-tax loss from discontinued operations, including settlement charges, costs associated with closing the business and operating losses to be $100 million to $125 million.
More than 18,000 people worldwide have received the Ancure system, Guidant said last week.