News | February 24, 2015

Analyst Says European Market Could Facilitate Prosthetic Heart Valve Advancements

Transcatheter mitral valve replacement (TMVR) device makers likely to utilize Europe’s relatively lax regulatory approval process for new product testing

TMVR, Europe, heart valve repair, GlobalData

February 24, 2015 — In light of a recent American Heart Association report stating that U.S. mitral valve regurgitation prevalence was 1.7 percent in 2014, a significant opportunity exists for development of an effective transcatheter mitral valve replacement (TMVR) device as an alternative treatment to surgery for inoperable patients. This assessment was given by an analyst with research and consulting firm GlobalData.

Furthermore, according to Premdharan Meyyan, GlobalData's analyst covering medical devices, TMVR device makers are expected to utilize the relatively lax regulatory approval process in the European market to test new products and amass clinical data; first-generation devices are likely to be approved within the next five years.

Mitral valve regurgitation patients comprise the largest segment of the U.S. population suffering from heart valve-related disorders. Some of them cannot be treated by conventional surgical repair methods due to associated comorbidities or other risk factors, creating a need for minimally-invasive therapies that will ultimately improve clinical outcomes.

“Following the shake-up of the surgical heart valve market with the emergence of minimally-invasive transcatheter aortic valve replacement (TAVR) procedures, key opinion leaders have asserted that a similar opportunity exists for companies to discover the easiest and safest way to put devices into the mitral position," said Meyyan.

“Although the complex anatomy of the mitral annulus makes successful implantation of a prosthetic device in this position more difficult than in the aortic position, major prosthetic heart valve manufacturers, such as Edward Lifesciences, are already executing TMVR development alongside their existing product lines,” Meyyan added.

The analyst adds that numerous smaller companies, including Neovasc and Micro Interventional Devices, are making a focused effort to develop technologies that overcome the clinical barriers specific to mitral valve replacement.

“While these devices are still years away from commercialization, early movers in the TMVR space are poised to seize considerable shares from key players in the billion-dollar prosthetic heart valve market, due to the large patient base,” Meyyan concluded.

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