Medtronic’s CoreValve Evolut R “Recapturable” TAVR Earns CE Mark
This article was originally published in The Gray Sheet
The next-generation version of the CoreValve transcatheter aortic valve can be repositioned during the implant procedure.
You may also be interested in...
The market opportunity for TAVR is significant, with 2013 sales totaling $303.4 million in the US and $765 million outside the US, and those numbers are expected to grow to an estimated $1.29 billion and $1.63 billion, respectively, by 2018. Edwards and Medtronic dominate the worldwide market at present, but other companies are expected to make inroads with next-generation devices designed to optimize outcomes.
The firm announced the CE mark and European launch of its transcatheter aortic heart valve replacement device Oct. 28. Boston is one of at least seven firms with a TAVR device now on the market in Europe.
FDA launches what it hopes will the final push to reform the regulatory oversight system for lab-developed tests by proposing a relatively rapid transition period to require essentially all LDTs to comply with the existing regulations for in vitro diagnostics. Legislation, litigation, and industry negotiation will likely shape the final product.