Guidant Halts Aorta Patch Salesgreenspun.com : LUSENET : Grassroots Information Coordination Center (GICC) : One Thread
Mar 16, 2001 - 06:20 PM
Guidant Halts Aorta Patch Sales The Associated Press
WASHINGTON (AP) - The maker of a novel way to patch a life-threatening weak spot on the body's biggest blood vessel unexpectedly halted production Friday, citing problems meeting federal rules. The problems don't affect some 12,000 patients who have a Guidant Corp. patch in their bodies to fix a condition called an abdominal aortic aneurysm, the Food and Drug Administration said.
Instead, they deal largely with what information Guidant provides to doctors about how to safely implant the patch and what complications can arise on the operating table, said FDA medical device chief Dr. David Feigal.
Companies are supposed to keep such information up to date to help doctors use new medical products as safely as possible. Feigal said Guidant told the FDA it hadn't kept pace and thus was temporarily halting sales and urging doctors to postpone new implants.
Feigal said Guidant had provided no details pending an agency meeting. The California-based company refused to answer questions Friday but estimated the move could cost $12 million.
The aorta runs from the heart to the groin. An aneurysm is a weak bulge in the aorta's wall that, if it gets big enough, can burst, killing quickly. Doctors estimate that 1.5 million older Americans have abdominal aortic aneurysms and that 15,000 a year die.
Guidant's Ancure hit the market in 1999, promising an easier alternative to grueling and dangerous open-abdominal surgery. With the Ancure, doctors slice an opening into a leg artery, thread the patch up to the weak aortic spot and position it so the patch's tiny hooks hold it in place.
AP-ES-03-16-01 1820EST http://ap.tbo.com/ap/breaking/MGAZ4DGJEKC.html
-- Carl Jenkins (firstname.lastname@example.org), March 16, 2001
This patch sounds like a great fix for some delicate surgery. Hopefully Guidant will get their instructions updated soon.
-- John Littmann (LITTMANNJOHNTL@AOL.COM), March 16, 2001.