Abbott's Minimally Invasive Mitral Repair Device May Have Hit FDA Speed Bump. Can Other Companies Prevail?
The FDA delivered a blow to Abbott Monday when a staff review ahead of a regulatory panel recommended that the agency reject the company's application for approval for its minimially invasive mitral repair device.
Mitral repair is aimed at tacking mitral regurgitation that occurs when the mitral valve doesn’t close tightly enough such that blood flows backward into the heart and not out to the rest of the body. Abbott's MitraClip involves implanting a device percutaenously using a steerable guide catheter and a clip delivery system.
In its report, FDA staff reviewers said
the data supporting the approval of the device are "not easily interpretable," the benefits of the procedure were out weighed by its risk profile, and that they were not convinced of the safety and efficacy of the device. However, they did recommend that the device be available to patients who are deemed to be at high risk for open heart surgery.
The report highlights an important issue and a broader question that is yet to be answered.
"What is the proper bar for efficacy for those devices that are also less invasive/have fewer side effects?" said medical technology venture capitalist Mike Carusi, general partner, Advanced Technology Ventures, in an email. "Should the bar be the same as surgery or is there a different risk/benefit equation (i.e., lower efficacy, lower adverse events)?"
More than a year ago, doctors at PCR London Valvers 2011 conference suggested that percutaneous approaches to mitral valve repair have a tough road to hoe
, given that the open heart surgical procedure has such positive outcomes.
Nonetheless, here are some companies attempting minimally invasive approaches to mitral valve repair.
This venture-backed company recently received CE Mark to market its implantable device. The procedure undertaken on a beating heart places artificial chords in the mitral valve and eliminate the need for sternotomy and cardiopulmonary bypass required in open heart surgery.
In January, NeoChord announced that it is planning to enrol patients in a registry training and proctoring for which would be provided by the Mayo Clinic and the University of Pittsburgh Medical Center. A March regulatory filing shows that the company has nabbed $3 million out of $5 million it is currently seeking.
Mardil Medical hopes to treat leaking mitral valves by its VenTouch system by which a device is put around a beating heart through a small incision in the ribs. The device essentially applies pressure on the valves helping them to close.
The company has won investment from the Malaysian government after it failed to raise money in the U.S.
This company deals with mitral valve regurgitation not by repairing the valves but by replacing them entirely. It uses a transcatheter approach to replace the dysfunctional valves.
Like NeoChord, CardiAQ is also backed by ventures, but it has raised much more money. For instance, in its latest regualtory filing dated Dec. 5, the company raised more than $37 million. The investor confidence comes mainly from an experienced leadership team including the CEO Rob Michels, who successfully saw the sale of the CoreValve, a transcatheter aortic valve implantation company to Medtronic for $700 million and additional milestone payments.
By Arundhati Parmar, Senior Editor, MD+DI
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