21 March 2013 | News | By BioSpectrum Bureau
The US FDA's opinion is that benefits of the treatment device outweigh its risks
Singapore: The US Food and Drug Administration (FDA) has supported Abbott's MitraClip device stating that the benefits of the treatment device outweigh its risks. The US FDA said it benefits patients with significant symptomatic mitral regurgitation (MR) who have been determined to be at high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the MR.
Abbott's MitraClip device, which received CE Mark in 2008 and is commercially available in Europe and other international markets, is an investigational device in the US. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together a portion of the leaflets of the mitral valve to allow the heart to more efficiently pump blood.
"We appreciate the FDA's dedication of time and resources to convene this advisory panel for MitraClip and for its review of this new and novel technology for high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation," said Mr Charles A Simonton, divisional vice president, medical affairs, and chief medical officer, Abbott.