Abbott Vascular has launched a catheter-based MitraClip system in Australia for patients suffering from mitral regurgitation (MR), a debilitating heart valve condition.
The MitraClip device, which has received Therapeutic Goods Administration (TGA) approval, includes a catheter-based device that is delivered to the heart through the femoral vein, a blood vessel in the leg.
The MitraClip is designed to reduce significant MR by clipping together the leaflets of the mitral valve, one of the four valves of the heart.
The first-in-man clinical trial of the MitraClip system was conducted in the US, where it is an investigational device currently under review for approval by the US Food and Drug Administration.
The safety and efficacy of the MitraClip system was evaluated in EVEREST II, the first randomized clinical trial to compare a catheter-based mitral valve device to mitral valve surgery.
The MitraClip system received CE mark in March 2008 and is commercially available in Europe, Turkey, Israel and Australia.