FDA orders seizure of Vail beds
U.S. marshals last week seized adulterated and misbranded hospital bed systems manufactured by Vail Products at the request of the Food and Drug Administration in response to ongoing concerns about manufacturing quality and labeling, the FDA said. The seizure encompassed all Vail 500, 1000 and 2000 enclosed bed systems, which the FDA said can entrap and suffocate patients, resulting in severe neurological damage or death. The agency said it is aware of approximately 30 such entrapments, at least seven of them resulting in death. Consumers were advised to stop using such systems until they received additional instructions from Vail. The Toledo, Ohio-based company previously received two FDA warning letters outlining unacceptable practices and was given an opportunity to correct the violations, but failed to do so, officials said.
Stents tested in other arteries
The first U.S. trial is under way to test whether drug-eluting stents, which have had rapid success in treating coronary artery disease, offer similar benefits in treating diseased arteries outside the heart. The first patient was treated last week at Stanford University Medical Center, Palo Alto, Calif. The trial is testing the safety and effectiveness of the Zilver PTX paclitaxel-eluting stent developed by Cook, Bloomington, Ind., to clear blockages in the major artery in the thigh.
J&J to buy TransForm
Johnson & Johnson plans to acquire TransForm Pharmaceuticals, Lexington, Mass., for approximately $230 million in a deal expected to close in the second quarter. J&J said earlier this month that it expects to incur a one-time charge of about $50 million for its acquisition of the privately held drug discovery and development company. The deal followed the announcement of J&J's plans to acquire Closure Medical Corp., Raleigh, N.C., for approximately $370 million.