Rancho Dominguez, California -- Avalon Laboratories llc has gained 510(k) clearances from the US Food and Drug Administration (FDA) and CE Mark acceptance from the European Union for three new polyurethane-silicone catheter devices used in life-support systems.
Avalon can begin distributing these Avalon Elite brand products to hospitals and healthcare systems in the US and the EU. The Avalon Elite Bi-Caval Dual Lumen Catheter was also issued US Patent No. 7473239, as a "Single Expandable Double Lumen Cannula Assembly for Veno-Venous ECMO," on 6 Jan 2009.
Avalon's Elite catheters use an embedded wire to prevent collapse or kinking, and are constructed with Avalon's Elast-Eon, a copolymer that it says combines the biostability of silicone with the strength and durability of polyurethane. The devices also feature the Avalon Elite Introducer System, a patent-pending integrated catheter and introducer design that makes it easier for healthcare providers to insert and position the device.
"The Avalon Elite line enables healthcare providers to evolve and improve the way patients are connected to critical life-support devices," said Robert Foster, chief executive officer of Avalon Laboratories, in a company statement. "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 benefitting from our efforts."
The clearances apply to Avalon's Bi-Caval Dual Lumen Catheter (DLC), the Multi-Port Venous Femoral Catheter, and the Vascular Access Kit.