The subsequent phase of the burgeoning and rapidly maturing transcatheter aortic valve replacement (TAVR) market place has begun. Edwards Lifesciences announced on Monday afternoon that the FDA had accredited its 2nd generation Sapien XT TAVR device for the therapy of large-threat and inoperable sufferers struggling from extreme symptomatic aortic stenosis (AS).
The Sapien XT is the successor to the first generation Sapien gadget, which supplied the initial nonsurgical method to aortic valve substitute. A competing gadget, Medtronic’s CoreValve, was approved earlier this year and has acquired significant curiosity. The Sapien XT is expected to be far more aggressive, in portion due to the fact of its reduced-profile and the availability of a 29 mm valve dimension for sufferers with a larger native annulus.
Edwards mentioned the Sapien XT will be immediately obtainable along with its accompanying transfemoral, transapical, and transaortic delivery techniques.
“There is a significant and growing physique of proof that the SAPIEN XT valve advantages both high-threat and inoperable patients, and clinicians have documented these consistently optimistic results in the two randomized studies and European nation registries,” mentioned Martin Leon, the co-principal investigator for the Spouse II Trial which evaluated the SAPIEN XT valve, in a press release. “The final results from the Partner II Trial in treating US inoperable sufferers with the SAPIEN XT valve demonstrated a reduction in issues with the TAVR method, and improved patient outcomes over earlier trials.”
FDA Approves Second Generation Heart Valve From Edwards Lifesciences
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