The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were not eligible for surgery.
The FDA also said the device could be delivered through both the transfemoral route and the transapical route. Previously the device could only be delivered through the transfemoral route.
“Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases that risk may be especially high,” said the FDA’s Christy Foreman, in an FDA press release. “The THV serves as an alternative for some very high-risk patients.” The FDA requires that before being deemed eligible for the Sapien valve a patient must be evaluated by a heart team, which includes a heart surgeon.
The FDA will continue to require Edwards to evaluate the Sapien device through a national registry.
Here is the press release from the FDA:
FDA expands approved use of Sapien artificial heart valve
The U.S. Food and Drug Administration today expanded the approved indication for the Sapien Transcatheter Heart Valve (THV) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
The FDA first approved the Sapien THV in 2011 for patients with inoperable aortic valve stenosis, a progressive, age-related disease. Calcium deposits on the aortic valve that cause it to narrow are a common cause of aortic valve stenosis. As the heart works harder to pump enough blood through the smaller opening, it eventually weakens. Aortic valve stenosis can lead to fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest.
Those with severe aortic valve stenosis must have a heart valve replacement to restore normal blood flow. Patients who are in good enough health to tolerate surgery usually undergo open-chest, open-heart surgery or a minimally invasive surgery, in which surgeons gain access to the heart through an incision between the ribs.
The Sapien THV is implanted without opening the chest or heart. The device is compressed into a thin, flexible tube called a delivery catheter. The delivery catheter and the THV are inserted into the femoral artery through a small incision in the leg and threaded to the site of the diseased valve. The THV is then released from the delivery catheter and expanded with a balloon and is immediately functional.
“Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases that risk may be especially high,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health. “The THV serves as an alternative for some very high-risk patients.”
The Sapien THV is approved for those who have a calcium build-up in the fibrous ring of the aortic heart valve and are either not eligible for open-heart surgery or who are considered to be a very high-risk surgery patient by a cardiologist or thoracic surgeon. The approved product labeling advises that a heart surgeon should be involved in determining if the Sapien THV is an appropriate treatment for the patient.
The device is contraindicated (should not be used) for patients who cannot tolerate anticoagulation/ antiplatelet therapy.
Clinical studies to support the expanded approval included a clinical study of 348 surgical patients who received the Sapien THV and 351 similar patients who received aortic valve replacement (AVR) through open-heart surgery. Both groups had similar death rates at one month, one year, and two years after the procedures.
Those who received the THV showed an increased risk for major vascular complications, such as artery dissection or perforation, and for stroke during the first month following the procedure. Patients who received the AVR were more likely than the THV recipients to experience major vascular bleeding during the procedure.
The manufacturer of the Sapien THV, Edwards Lifesciences Corp., of Irvine, Calif., will continue to evaluate the device through a national Transcatheter Valve Therapy registry, which facilitates the continued evaluation of transcatheter devices and procedures.
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.
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Here is the press release from Edwards:
FDA Approves Expanded Indication for Edwards Lifesciences’ Transcatheter Valve
IRVINE, CA–(Marketwire – October 19, 2012) – 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.
The safety and effectiveness of the SAPIEN valve were evaluated in a randomized, controlled pivotal study called The PARTNER Trial. Edwards submitted a Premarket Application (PMA) in April 2011 based on data from the high-risk cohort (Cohort A) of The PARTNER Trial. Cohort A compared the outcomes of patients at high risk for traditional open-heart surgery randomized to receive either surgical aortic valve replacement or the SAPIEN valve via transfemoral or transapical delivery. The trial was successful in meeting its primary endpoint at one year, concluding that survival of high-risk patients treated with the SAPIEN valve was equivalent to those treated with traditional open-heart surgery.
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. Wood and statements regarding future risks and 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, 2011.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation.