A Medical Device Daily

Atrium Medical (Hudson, New Hampshire) repor-ted receiving FDA 510K clearance for a new vascular implant device called the iVena Vascular Patch, indicated for use in the surgical repair and closure of the vascular system.

The patch is an extremely thin, reinforced biomaterial that features implantation with less blood loss and greater handling efficiency. It is an alternative to “conventional implantable vascular repair materials,” according to the company. It features a proprietary composite film lamination process that is used in Atrium's advanced vascular graft products called Flixene.

The iVena patch is expected to become commercially available in the 1Q07.

Atrium manufactures more than two million sterile medical devices, distributed worldwide. Atrium says it has brought advances in several markets including interventional cardiology, chest trauma care and thoracic drainage, vascular surgery, hernia and soft tissue repair.