FDA Approves Expanded Indication for Edwards Lifesciences' Transcatheter Valve

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that it has received approval from the United States Food and Drug Administration (FDA) to treat high-risk aortic stenosis patients with the Edwards SAPIEN transcatheter aortic heart valve delivered both transfemorally (via the leg) and transapically (through the ribs). With the addition of high-risk patients to those eligible for the transcatheter procedure and with the approval of the transapical approach, a considerably broader group can now be treated with the SAPIEN valve. Previously, SAPIEN was approved in the U.S. only for the treatment of inoperable patients via the transfemoral approach. "We are thankful to the multidisciplinary Heart Teams who worked diligently throughout The PARTNER Trial to bring new treatments to U.S. patients at high risk for surgical aortic valve replacement," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "It is extremely rewarding for us and our clinical partners to know that high-risk patients suffering from this often debilitating disease will now have access to this life-saving therapy." About Transcatheter Aortic Valve Replacement (TAVR)In performing the TAVR procedure, the valve is crimped onto the catheter-based delivery system and inserted into the body in one of two ways: transfemorally or transapically. Once delivered to the site of the patient's diseased valve, the SAPIEN valve is expanded with a balloon and immediately functions in place of the patient's native aortic valve. The Edwards SAPIEN valve is indicated for the treatment of patients with severe symptomatic calcified native aortic valve stenosis who have been examined by a Heart Team, including an experienced cardiac surgeon and a cardiologist, and found to be inoperable or at high risk for traditional open heart surgery, and in whom existing co-morbidities would not preclude the expected benefit from the procedure. The previous FDA approval for the treatment of inoperable patients was granted on Nov. 2, 2011.