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Societies Gain FDA Go-Ahead, Medicare Coverage To Study New Access Methods For Edward’s Sapien Valve

It’s the first time Society of Thoracic Surgeons and American College of Cardiology have ever filed for an investigational device exemption. 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.

The Society of Thoracic Surgeons and American College of Cardiology gained investigational device exemption approval from FDA and Medicare coverage from CMS last 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 expand access to Sapien to more patients not currently included in FDA labeling.

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