Covidien has received clearance from the FDA to market a medical device, called the Mallinckrodt TaperGuard Evac endotracheal tube, created to reduce the risk of postsurgical complications caused by the aspiration of fluids into the lungs. Although complications from pulmonary aspiration are rare, the consequences can be severe, Covidien said.

The FDA is reconsidering the approval of ReGen Biologics Inc’s knee device after an investigation showed that unprecedented industry and Congressional involvement influenced the agency’s decision. Joshua Sharfstein, the agency’s principal deputy commissioner, said, however, that patients who have had Menaflex implanted in their knee need not panic and noted that the device is still on the market. ReGen Chief Executive Gerald Bisbee said in a statement that the report didn’t evaluate the scientific evidence about the device. The company said the product is safe and helps knee-surgery patients recover more quickly.

A study published in the June 2009 issue of the Archives of Surgery depicted that laparoscopy-assisted surgery for early gastric cancer resulted in a 98.8% three-year overall survival rate in patients with early gastric cancer. Laparoscopic gastrectomy is a minimally invasive surgical procedure, in contrast with the total removal of the lymph nodes in traditional treatment. In Laparoscopic gastrectomy, a surgeon removes the stomach through a lighted tube, eliminating the need for large surgical incisions and possibly reducing the risk of infection, healing complications, pain and blood loss.

Angiotech Pharmaceuticals is halting enrollment in clinical trials for Vascular Wrap, which is being evaluated in patients undergoing surgery for hemodialysis access, pending a safety review. The company has been conducting the study in the U.S. and Europe on two groups, one which received the wrap in combination with a graft and one which received the graft alone. After reviewing a summary of interim adverse events, a data safety monitoring board has informed the company that one of the two study groups had a greater incidence of implant site infection.

Dr Shane Grey of the Garvan Institute for Medical Research and Professor John Dalton of the Institute for the Biotechnology of Infectious Diseases are working towards copying the parasites’ tactic of making the body accept transplanted tissues or organs. Parasites work by deviating the immune system so that it is unable to come up with an effective response.

The FDA has approved the Aloxi(R) (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours after surgery. The injection has been developed by Eisai Corporation of North America, its U.S. subsidiary, MGI Pharma, and Helsinn Healthcare SA. Aloxi already had FDA approval, since 2003, for the prevention of acute and delayed nausea and vomiting associated with chemotherapy.