Dive Brief:

• FDA Thursday said it expanded the indication for Abbott's MitraClip device for the minimally invasive repair of secondary mitral regurgitation, a heart valve condition. The catheter-based device has been approved in the United States to treat primary mitral regurgitation since 2013.
• Results from the COAPT trial supported the approval. The study evaluated the device in 614 heart failure patients with moderate to severe secondary mitral regurgitation. The device met the primary efficacy endpoint for heart failure hospitalization and the primary safety endpoint of freedom from device-related complications at one year.
• Abbott said it will accordingly request a revision to Medicare's national coverage determination to expand reimbursement to secondary mitral regurgitation patients.

Dive Insight:

Following the successful development of catheter-based treatments for aortic valve disease over the past 15 years, several leading medical device makers are now focused on advancing minimally invasive procedures for mitral valve disease, which is found in an even larger population of patients. Mitral regurgitation is the most prevalent form of valve disease, affecting about one in 10 people over the age of 75, compared to one in 20 who have a faulty aortic valve, according to American Heart Association statistics.

Because the mitral valve is considered more challenging to repair, development of new techniques to tackle the condition has been slower. Abbott has led the pack in minimally invasive treatments with the MitraClip, but competition is coming as some of the device maker’s traditional rivals make acquisitions to position themselves in the mitral valve segment.

M&A has dominated the race for mitral market position. The challengers include Edwards Lifesciences and Medtronic, the only two companies with transcatheter aortic valve replacement (TAVR) devices on the U.S. market, who both made moves in 2015, buying CardiAQ and Twelve, respectively, to gain access to their mitral valve technologies in development. Likewise, Boston Scientific bought valve repair startup Millipede for $325 million last year. Abbott itself has moved to bolster its leading spot in the mitral valve space with the acquisition of Cephea Valve Technologies, announced in January.

Unlike primary mitral regurgitation associated with the structure of a valve, secondary mitral regurgitation may develop in heart failure patients when the left chamber of the heart becomes enlarged. This can prevent the mitral leaflets from closing normally, which allows blood to flow backwards through the heart.

The MitraClip device repairs the valve without open heart surgery and is delivered to the heart through a small incision in the leg. The device clips together the two leaflets of the mitral valve to reduce the backflow of blood, enabling the heart to pump more efficiently.

In the COAPT clinical trial, which was first presented during the Transcatheter Cardiovascular Therapeutics meeting in September 2018, the risk of rehospitalization for heart failure symptoms was reduced by 47% in the MitraClip group compared to the control group. The risk of death within two years was reduced by 37% in the MitraClip group.