MASSDEVICE ON CALL —Brazilian device maker Braile Biomedica announced the launch of its Inovare transcatheter aortic valve replacement system this week.
The device won approval from Brazilian regulators in November 2011 after hitting clinical endpoints in 93% of procedures in the company’s clinical trials.
In a study of about 150 patients, more than ¾ of which were considered at high risk for surgery while the rest were inoperable, there were 3 deaths within 30 days and mortality rose to 50% at 2 years for the 79 patients for whom data was available, according to TheHeart.org.
The device is only approved for transapical procedures, according to the news outlet, but Braile is also looking to gain approval for a transfemoral approach.
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