Shots:
- The US FDA has granted PMA approval to the Trilogy THV System to treat ssAR in pts at high or greater surgical risk, with immediate launch planned via participating study sites, followed by hospitals across the US
- Approval was supported by the results from ALIGN-AR pivotal IDE trial assessing safety & efficacy of the Trilogy system in high-surgical-risk pts with ssAR
- The System uses radiopaque locators to attach directly to native aortic leaflets without calcification, allowing stable implantation, precise alignment, reduced paravalvular regurgitation, & preserving future coronary access with its open-cell nitinol frame
Ref: Globenewswire | Image: JenaValve | Press Release
Related News: Myriad Genetics Receives the US FDA Approval for MyChoice CDx Test as a Companion Diagnostic for GSK’s Zejula
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