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 Elite DLC is indicated for use as a single catheter for simultaneous venous drainage and re-infusion of blood via the internal jugular vein during extracorporeal life support procedures. The DLC is designed to increase the efficiency of blood gas exchange by draining blood from both the upper and lower body while simultaneously reinfusing it directly into the heart. The device is more efficient and less traumatic for patients than previously available devices.
Because it is designed to be inserted through the skin, the external diameter of the DLC is gradually tapered to promote smooth insertion. This advanced catheter is wire-reinforced to resist kinking and collapsing and is offered in seven different sizes to accommodate use in patients from infant and pediatric to adult. Currently available DLCs are cleared for use only in small children, and can result in significant recirculation, insufficient venous drainage and problems with kinking and collapsing which lead to insufficient gas exchange.
Avalon Elite(tm) Multi-Port Venous Femoral Catheter
The Avalon Elite Multi-Port Venous Femoral Catheter incorporates advanced materials and physician-focused engineering to make it flexible, kink resistant and high performing. The catheter is offered in five sizes to better match the needs of individual patients. Blood drainage is optimized with multiple strategically placed, wire-reinforced ports. This catheter's design improvements facilitate vascular insertion, enhanced placement and uninterrupted support and performance.
Avalon Elite(tm) Vascular Access Kit
Accompanying these devices is the Avalon Elite Vascular Access Kit, designed to help health care providers insert catheters and cannulae wherever they are needed. The kit provides an assortment of patent-pending small- and large-bore Avalon Elite dilators, designed with thin, flexible tips and robust proximal shafts to enable precise guide wire tracking and smooth, gradual vessel dilation.
|Contact: Rebecca Howe|
Lambert, Edwards & Associates