Avalon Laboratories has received 510(k) clearances from the FDA and CE Mark from the European Union for three new catheter devices used in medical life support systems.
The Los Angeles-based company said the clearances enable to begin distributing the products to hospitals and health care systems in the U.S. and the European Union. Avalon also was issued U.S. Patent No. 7473239 for a Single Expandable Double Lumen Cannula Assembly for Veno-Venous ECMO, on Jan. 6.
Avalon said its Elite catheters utilize an embedded wire-layering technology to resist collapsing and kinking, and are constructed with Avalon’s Elast-Eon copolymer that combines the biostability of silicone with polyurethane. Both devices feature the Avalon Elite Introducer System, the patented, integrated catheter and introducer design that makes insertion and positioning easier. Avalon’s Elite Vascular Access Kit provides designed accessories to aid the use of its Elite catheters.
The clearances apply to the Avalon Elite Bi-Caval Dual Lumen Catheter, the Avalon Elite Multi-Port Venous Femoral Catheter and the Avalon Elite Vascular Access Kit, the company said.