Saturday, December 11, 2004

Evalve Percutaneous MV Repair System

Filed under: Cardiac Surgery , Radiology

From a recent press release by Evalve:

A tiny clip device that can be delivered by a catheter and deployed in the heart to repair a malfunctioning and leaking mitral valve is building a favorable safety and feasibility profile as it nears completion of a nationwide Phase I trial.

To date, a total of 24 patients who suffered from severe mitral valve regurgitation (MR) have received the clip as part of a clinical study under an FDA-approved investigational device exemption (IDE). The clip is a product of medical device company Evalve Inc., located in Redwood City, CA. Based on these promising results, a larger, Phase II safety and efficacy trial may be initiated later this year.

According to Evalve's web site, this device is being tested on people with moderate to severe mitral regurgitation, originating from the central two-thirds of the valve. Pts with rheumatic heart disease are excluded. There is no information provided about what type of Carpentier classified MR is being included in the testing. This is surely an interesting device. We will be following up on this story as more information is available...

                (0)