New Expanded Indication Could Change the TAVR Narrative

The transcatheter aortic valve replacement market received one of the biggest jolts of the year when FDA expanded indications of both Edwards Lifesciences and Medtronic’s valves. FDA’s measure would open up the valves to be used in younger and low-risk patients. The agency said these transcatheter valves – Edwards’ Sapien 3, and Sapien 3 Ultra, with Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery. “This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in FDA’s Center for Devices and Radiological Health. In a clinical study to evaluate safety and effectiveness, 503 patients with severe aortic stenosis at low-risk for surgical complications were randomly selected to have aortic valve replacement with Irvine, CA-based Edwards' Sapien 3 transcatheter heart valve, and 497 were randomly selected to have aortic valve replacement with traditional open-heart surgery using an approved surgical tissue valv...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news