Avalon Laboratories has just received 510(k) clearances from the U.S. Food and Drug Administration, as well as CE Mark acceptance from the European Union, for three of its new catheter devices. The FDA clearances and E.U. acceptance allowed Avalon to immediately begin distributing the devices to hospitals and health care systems domestically and in the European Union. The new medical device products are marketed under the names Avalon Elite Bi-Caval Dual Lumen Catheter, the Avalon Elite Multi-Port Venous Femoral Catheter and the Avalon Elite Vascular Access Kit.
Avalon also just received a patent for its Avalon Elite Bi-Caval DLC, which is the first DLC for adults and large pediatric patients. The company developed the Avalon Elite Bi-Caval DLC in collaboration with two University of Kentucky faculty members, and university’s medical center will be the first to offer the technology to its patients later this month.
“The Avalon Elite line enables health care providers to evolve and improve the way patients are connected to critical life support devices,” said Robert Foster, chief executive officer of Avalon Laboratories, LLC. “These regulatory clearances will provide new options for critically ill patients suffering from lung failure. We have worked very hard over the last three years to bring these important new devices to market; it is hugely satisfying for all of us at Avalon, to see patients benefiting from our efforts.”
All three devices were developed at Avalon’s research and development offices in Grand Rapids. Avalon is a leading global supplier of wire-reinforced cardiopulmonary vascular devices used to remove or introduce fluid into the body. The company manufactures more than three-quarters of all such devices used around the world.