Medtronic Nabs First Superiority Outcome In TAVR Versus Surgery
This article was originally published in The Gray Sheet
Executive Summary
Data from Medtronic’s CoreValve High Risk Study provide the firm with significant momentum toward expanding the FDA label for its transcatheter aortic valve replacement device. Based on the results, FDA says no advisory panel will need to meet for the firm’s high-risk surgery submission. Observers say the jury is still out on CoreValve versus Sapien question.
You may also be interested in...
TAVR Researchers Look To Lower-Risk Patients, Less Data Demands
Edwards Lifesciences' Sapien 3 valve looked good at the annual American College of Cardiology conference, including in intermediate-risk patients. Could it mean less follow-up demands for future approvals? Meanwhile, Medtronic continued to press its status as the only company with a TAVR device shown superior to surgery.
New TAVI Head-To-Head: Sapien XT Vs. Surgery-Superior CoreValve
Edwards Lifesciences will bring its next-generation transcatheter aortic valve implant (TAVI) system, Sapien XT to the U.S. just in time to face the growing threat of competition from Medtronic’s CoreValve, which earned an expanded FDA indication for patients at high risk for surgery.
CoreValve May Go From “Superior” To Stalled Following Court Ruling
[Updated to incorporate comments from Edwards and Medtronic about ongoing negotiations, and more details on Medtronic’s emergency motion] A preliminary injunction ruling for Medtronic’s CoreValve device is an unexpected twist in a long-running transcatheter aortic valve patent suit between Medtronic and Edwards Lifesciences, and could give Edwards a significant edge in the market for several years to come.