STS, ACC Gain IDE Approval To Study New Access Methods For Edward’s Sapien Valve

STS, ACC Gain IDE Approval To Study New Access Methods For Edward’s Sapien Valve-thegraysheet: The Society of Thoracic Surgeons and American College of Cardiology gained investigational device exemption approval from FDA this week to study unapproved “alternative access” techniques for Edwards Lifesciences Corp.’s Sapien transcatheter valve in inoperable patients with severe aortic stenosis. The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.