After much anticipation and drama, the FDA has approved the Sapien transcatheter aortic heart valve. The news was announced late Wednesday afternoon by the FDA and by Edwards Lifesciences, the manufacturer of the device.
Details about the approval are scarce. The FDA said the Sapien THV had been “approved for patients who are not eligible for open-heart surgery for replacement of their aortic valve and have a calcified aortic annulus (calcium build-up in the fibrous ring of the aortic heart valve).” In addition, the produce label “advises that a heart surgeon should be involved in determining if the Sapien THV is an appropriate treatment for the patient.”
In its announcement the FDA noted that although patients in the pivotal PARTNER B trial who received Sapien had two and a half times the number of strokes and eights as many vascular and bleeding complications than medically-treated controls, after one year 69% of patients in the Sapien group were alive, compared to only 50% of controls.
The FDA also said that Edwards “will continue to evaluate the outcomes with the Sapien THV through a national Transcatheter Valve Therapy (TVT) registry, which is under development by the Society of Thoracic Surgeons and the American College of Cardiology, in conjunction with the FDA and CMS. In its statement Edwards said it would also continue to follow patients enrolled in the PARTNER trial.
Here are the press releases from the FDA and Edwards:
FDA approves first artificial aortic heart valve placed without open-heart surgery
The U.S. Food and Drug Administration today approved the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery.
Senile aortic valve stenosis is a progressive, age-related disease caused by calcium deposits on the aortic valve that cause the valve to narrow. As the heart works harder to pump enough blood through the smaller valve opening, the heart eventually weakens, which can lead to problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest.
Once symptoms of senile aortic stenosis occur, more than half of patients die within two years. To restore normal blood flow, patients with severe aortic valve stenosis need open-heart surgery to replace the diseased valve. However, the procedure is too risky for some patients.
“Surgery to replace the aortic valve is an effective treatment for severe senile aortic valve stenosis. The Sapien Transcatheter Heart Valve (THV) is an example of an innovative new device that will provide some people with this condition who can’t undergo open heart surgery with the option of valve replacement,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The agency remains committed to working with companies who are developing breakthrough treatments that will have a significant impact on patient care in the U.S.”
The Sapien THV is made of cow tissue and polyester supported with a stainless steel mesh frame. To replace the diseased valve, the Sapien THV is compressed into the end of a long, thin, tube-like device called a delivery catheter. The delivery catheter, which is slightly wider than a pencil, and the Sapien THV are inserted into the femoral artery through a small cut in the leg and threaded to the site of the diseased valve. The heart valve is then released from the delivery catheter and expanded with a balloon and is immediately functional.
The FDA’s approval of the Sapien THV is based on a study in 365 patients who were not eligible for open-heart surgery. Half of the patients received the Sapien valve. The other study patients received another treatment that did not require open-heart surgery. One alternative procedure involved enlarging the aortic valve opening by stretching it with a balloon (balloon valvuloplasty).
Patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant; however, they were more likely to survive one year after surgery. After a year, 69 percent of the Sapien patients were alive compared with 50 percent of those who received an alternative treatment.
Edwards Lifescience, the manufacturer of the Sapien THV, will continue to evaluate the outcomes with the Sapien THV through a national Transcatheter Valve Therapy (TVT) registry. The Society of Thoracic Surgeons and the American College of Cardiology have been working with the FDA and the Centers for Medicare and Medicaid Services to facilitate the creation of the national TVT registry that will serve as a platform for continued evaluation of post market experience with this and future transcatheter devices and procedures for the treatment of aortic stenosis.
The most common serious and potentially life-threatening side effects in patients receiving the Sapien valve and the procedure to implant the valve include death, stroke, perforation of the blood vessels, ventricle or valvular structures, damage to the conduction system in the heart, significant bleeding, and leaks around the new valve.
The Sapien THV is approved for patients who are not eligible for open-heart surgery for replacement of their aortic valve and have a calcified aortic annulus (calcium build-up in the fibrous ring of the aortic heart valve). The product label advises that a heart surgeon should be involved in determining if the Sapien THV is an appropriate treatment for the patient.
It is not approved for patients who can be treated by open-heart surgery. Patients who have congenital heart valve anomalies, have masses or an infection in their hearts, or cannot tolerate anticoagulation/antiplatelet therapy should not receive the Sapien THV.
Edwards Lifescience is located in Irvine, Calif.
For more information:
FDA: Medical Devices
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Here is the Edwards press release:
Edwards Lifesciences Receives FDA Approval for First Catheter-Based Aortic Heart Valve in the U.S.
IRVINE, CA–(Marketwire – November 02, 2011) – Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the transfemoral delivery of the Edwards SAPIEN transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis. This is the first U.S. commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.
Transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN valve enables multi-disciplinary heart teams to replace a patient’s diseased aortic valve without traditional open-heart surgery and while the heart continues to beat — avoiding the need for cardiopulmonary bypass.
“This day marks an important milestone for inoperable American patients who have long been awaiting a therapeutic option for the often debilitating symptoms associated with severe aortic stenosis,” said Michael A. Mussallem, Edwards’ chairman and CEO. “We are extremely proud of the dedication of the heart teams and the patients involved in the clinical trial for this therapy, who have paved the way for this therapy to help even more people around the world.”
In performing the TAVR procedure, the valve is crimped onto the catheter-based transfemoral delivery system, which is inserted into the body through a small cut in the leg. Once delivered to the site of the patient’s diseased valve, the Edwards SAPIEN valve is expanded with a balloon and immediately functions in place of the patient’s native valve.
The Edwards SAPIEN valve is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.
The safety and effectiveness of the Edwards SAPIEN transcatheter valve were evaluated in a randomized, controlled pivotal study called The PARTNER Trial. The name of the trial signifies the important partnership between cardiac surgeons and interventional cardiologists, who were brought together to collaborate in patient evaluation, treatment and follow-up. Additional analyses of data from The PARTNER Trial demonstrated that patients receiving the SAPIEN valve experienced substantially better quality of life as compared to the control group patients, and also that TAVR was cost effective.
As part of this approval, FDA has requested the implementation of two substantial post-approval studies. One study will follow patients already enrolled in The PARTNER Trial, and the second study will track new U.S. patients. The company anticipates the second study will be incorporated into a new national patient registry.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements made by Mr. Mussallem and statements regarding the post-approval studies for, and the benefits of, the Edwards SAPIEN valve. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause the outcomes to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected regulatory or reimbursement decisions and longer-term clinical experience. These factors are detailed in the company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2010.
Edwards, Edwards Lifesciences, the stylized E logo, and Edwards SAPIEN are trademarks of Edwards Lifesciences Corporation.