Los Angeles, Calif. - January 15, 2009 - Avalon Laboratories, LLC (Avalon) today announced it has received 510(k) clearances from the U.S. Food and Drug Administration (FDA) and CE Mark acceptance from the European Union for three new catheter devices used in medical life support systems. The clearances enable Avalon to begin distributing these products to hospitals and health care systems in the United States and the European Union. The company also was issued U.S. Patent No. 7473239 for a Single Expandable Double Lumen Cannula Assembly for Veno-Venous ECMO, on January 6, 2009.
Avalon's Elite(tm) catheters utilize an embedded wire layering technology to resist collapsing and kinking, and are constructed with Avalon's Elast-Eon(tm) copolymer that combines the biostability of silicone with the strength and durability of polyurethane. Both devices feature the Avalon Elite Introducer System, the patent-pending integrated catheter and introducer design that makes it easier for health care providers to insert and position the device. Avalon's Elite Vascular Access Kit provides uniquely designed accessories to aid the use of its Elite catheters.
"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 benefitting from our efforts."
The clearances apply to the Avalon Elite Bi-Caval Dual Lumen Catheter (DLC), the Avalon Elite Multi-Port Venous Femoral Catheter and the Avalon Elite Vascular Access Kit.
Avalon Elite(tm) Bi-Caval Dual Lumen Catheter (DLC)
The Avalon El
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