Abbott Laboratories, a medical device manufacturer based in Abbott Park, Illinois, announced that it has received a panel date with the United States Food and Drug Administration for review of its MitraClip device. The MitraClip is a novel aortic valve repair system designed for patients suffering from mitral valve regurgitation.
According to a press release by the company, the FDA’s Circulatory Devices Panel will meet on the 20th of March to discuss potential regulatory approval for the MitraClip device.
The MitraClip system comprises a steerable sleeve, a delivery catheter and a percutaneous mechanical clip. The device is intended to treat mitral valve regurgitation in patients who don’t qualify for open-heart surgical intervention.
The device is inserted into the femoral vein of a patient through a specialized catheter. Once inserted into the femoral artery, a surgeon threads the device through a patient’s circulatory system and into the heart.
In January of last year, the company released results for its Everest II trial of the device. Results from the clinical trial showed that the device demonstrated efficacy at left reverse remodeling, reduced mitral regurgitation and improve clinical symptoms 12 months after implantation. Another recent study of the device showed positive clinical outcomes for reducing mitral valve regurgitation in older patients who don’t qualify for open-heart surgery.
Abbott is also a pioneer in the field of bioresorbable stents.
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