TAVR Researchers Look To Lower-Risk Patients, Less Data Demands
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
US FDA Approves First Intermediate-Risk Indication For TAVR
The expanded indication for Edwards' Sapien XT and Sapien 3 arrives about when the company had predicted.
Medtronic Nabs First Superiority Outcome In TAVR Versus Surgery
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.
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.