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The company’s second-generation transcatheter mitral valve repair system has been used to treat at least 15 patients in a pilot study across the US, Canada, and Australia. Interim results show significant and sustained reduction in mitral regurgitation without increased pressure gradient across the valve. The technology offers a less invasive alternative for patients with complex anatomy not suitable for existing percutaneous therapies or open-heart surgery.
Presentations of interim data have been made at major cardiology conferences such as New York Valves. The ongoing pilot study aims to enroll approximately 30 patients.
First-in-human procedures were completed successfully as early as January 2021.
The device remains investigational.
No commercial sales or pivotal trial data yet.
No FDA approval yet; still under clinical investigation.
Notable for being fully repositionable and recoverable during deployment.
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