Abbott Labs (ABT 0.49%) announced in a recent press release that its catheter-based MitraClip system, used to treat mitral regurgitation, showed positive results in a trial evaluating its clinical and quality-of-life results on patients with conditions too risky for surgery.
Mitral regurgitation is a common heart valve insufficiency that afflicts one in 10 individuals aged 75 and older, according to Abbott. The condition can ultimately lead to heart attack, stroke, and heart failure, among other outcomes. Abbott designed MitraClip to allow the heart to pump blood with greater efficiency.
The recent trial showed patients accepting MitraClip with a 96% implant success rate, along with few adverse effects and a mortality rate lower than expected, even though the patients were deemed as too high-risk to be treated with surgery.
Dr. Charles A Simonton, Abbott Vascular chief medical officer and divisional vice president of medical affairs, spoke in the release about MitraClip's possibility of being approved to treat other similar patients: "These results add to the large and growing body of data that show that the first-in-class percutaneous MitraClip therapy can have positive results for high surgical risk patients. ... We look forward to the March 20 FDA Advisory Committee meeting to discuss the MitraClip system as a treatment option for this patient group in the United States."
MitraClip has already been awarded CE Mark approval in 2008 and is available in more than 30 nations, although it is still an investigational product in the United States.
