Edwards Reveals Sapien Launch Plans For Transapical Delivery Method
This article was originally published in The Gray Sheet
Edwards estimates that the approximately 20%-30% of patients who would otherwise qualify but can’t receive a Sapien valve because their femoral artery is too small would likely make good candidates for the transapical, through the ribcage, route.
You may also be interested in...
Edwards Lifesciences is lowering its revenue expectations for 2013 based on adoption rates so far of its transcatheter aortic valve implant technology.
How will CMS’ move into bundled payments impact hospitals’ approach to purchasing and adopting devices?
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.