Wednesday, August 31, 2011

Cook Endoscopy Recalls Disposable Hemostasis Clips for Gastroenterologists

Cook Endoscopy is recalling its Disposable Hemostasis Clip, DCH-7-230, according to a Total Recall report.
The company warned that the disposable clip may not deploy after being positioned inside the patient.
The device is used for endoscopic marking, hemostasis for mucosal sub-mucosal defects less than 3cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm wide and polyps less than 1.5 cm in diameter in the GI tract.

Baxter Announces FDA Approval of ARTISS Fibrin Sealant for Use in Face-Lift (Facial Rhytidectomy) Procedures

DEERFIELD, Ill., Aug 31, 2011 (BUSINESS WIRE) -- Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has expanded the indication of ARTISS [Fibrin Sealant (Human)] to include adhering tissue flaps during facial rhytidectomy surgery (face-lift). ARTISS is the only premixed, ready-to-use fibrin sealant specifically indicated for tissue adherence in facial rhytidectomy (face-lift) and burn surgeries. It was first approved by the FDA in 2008 to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations one year of age or older.