HighLife’s TSMVR System Obtains the US FDA’s IDE Approval to Commence Clinical Trial for Treating Mitral Regurgitation
Shots:
- The US FDA has approved the company’s IDE of the Trans-Septal Mitral Valve Replacement (TSMVR) system to conduct its clinical evaluation across the US. The technology will be highlighted at the NY Valves annual meeting 2024
- The company is planning to enroll patients in pivotal trial to evaluate the safety and efficacy of the TSMVR solution for treating moderate to severe Functional Mitral Regurgitation (FMR) patients, ineligible for surgery or transcatheter repair treatment at sites across the US, EU & APAC
- HighLife's TSMVR solution is based on the valve-in-ring concept, in which the valve and ring are implanted percutaneously. The system is implanted into a beating heart in 3 steps, enabling reduced patient trauma
Ref: HighLife | Image: HighLife
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
