Medical Device Daily Associate Managing Editor

Atrium Medical (Hudson, New Hampshire) reported that it has received FDA 510(k) clearance for a new vascular product called Flixene.

Indicated for vascular access and arterial vascular reconstruction, Flixene vascular grafts offer, the company said in a statement, “the discriminating surgeon an exciting new alternative to traditional 20- to 30-year-old vascular graft technologies.” It describes the Flixene vascular graft as a product of “next generation” composite graft construction offering “exceptional strength, handling and durability.”

Built from a proprietary biomaterial film lamination process, Flixene features kink and compression resistance for improved handling and minimal needle hole bleeding. Additionally, this biomaterial provides “burst” and “suture strength” designed to minimize “weeping” often seen with traditional vascular bypass grafts following implantation, the company said.

“What we've been able to do is find a way to actually eliminate strike-though [which can cause graft 'weeping] or seepage in this graft,” Chad Carlton, vice president of marketing for vascular systems at Atrium, told Medical Device Daily.

“When you look at the physical strength characteristics of this [material],” said Carlton, “it beats everything else that's out there.” He said Flixene has about 168 pounds of radial tensile strength, compared to a competitor's material with 30 pounds of tensile strength.

Carlton said the product has been under development for about three years and that its introduction creates a brand new implant platform for future drug-eluting and coating products, in a variety of challenging vascular disease conditions requiring surgical intervention.

Until the company has firm clinical data on this new product, Carlton said the company won't supplant its older products. He projected Flixene rollout in 3Q06 and sold at a “slight premium” to comparable products in the sector.

Competitors in the vascular graft space include W.L. Gore (Flagstaff, Arizona), Thoratec (Pleasanton, California), Boston Scientific (Natick, Massachusetts) and CR Bard (Murray Hill, New Jersey).