The U.S. Food and Drug Administration today approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.
“Patients with advanced heart failure have limitations of physical activity, experiencing fatigue, palpitation or shortness of breath with activity and may not benefit from standard treatments, including currently marketed drugs and devices. This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “The FDA continues to work with manufacturers through our Breakthrough Devices Program to provide patients and health care providers with timely access to medical devices that have the potential to lead to a clinical improvement in patients, such as those with this irreversibly debilitating condition, while ensuring these devices meet our regulatory requirements for safety and effectiveness.”
About 5.7 million people in the United States have heart failure, a condition in which the heart cannot pump enough blood to meet the body’s needs. The leading causes of heart failure are diseases that damage the heart, such as high blood pressure and diabetes. Treatment for heart failure includes treating the underlying causes and reducing symptoms such as fatigue and swelling in the lower extremities that make physical activity difficult. Doctors may prescribe medications like angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers or beta blockers to lower blood pressure and reduce strain on the heart, as well as diuretics to reduce fluid buildup in the lungs and swelling in the feet and ankles.
The Barostim Neo System includes a pulse generator that is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck. After the device is implanted, a physician tests and programs the device, which delivers electrical impulses to cells in the neck called baroreceptors, which sense how blood is flowing through the carotid arteries and relays information to the brain. The brain, in turn, sends signals to the heart and blood vessels that relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.
The FDA evaluated data from a prospective, multi-center, two-arm, randomized clinical trial with a total of 408 patients with advanced heart failure. All patients received guideline-directed medical therapy, including medication, and 125 patients also received a Barostim Neo System implant. Patients receiving the implant showed improvements in the distance they were able to walk in six-minute walking tests and improvements in how symptoms impacted their quality of life. Also in the trial, 102 randomized subjects with less severe chronic heart failure found benefit in lowering levels of a biomarker that measures heart failure.
Potential complications associated with the implantation or use of the device include: infection; need for reoperation; low blood pressure that may cause dizziness, fainting, and/or falls; nerve damage; surgical or anesthetic complications; allergic reaction; arterial damage; exacerbation of heart failure; stroke; and death.
The Barostim Neo System is indicated for patients who have a regular heart rhythm, are not candidates for cardiac resynchronization therapy, and have a left ventricular ejection fraction (the total amount of blood pumped out in each heart beat) of less than or equal to 35%, which is considered below the normal ejection fraction of 55 to 75%. The device is contraindicated for patients with anatomy that would impair implantation of the device, certain nervous system disorders, uncontrolled and symptomatic slow heart rate, atherosclerosis or ulcerative plaques near the implant location and patients with a known allergy to silicone or titanium.
The device was approved using the Premarket Approval (PMA) pathway. Premarket approval is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).
As part of the approval of this device, the FDA is requiring the manufacturer to conduct a post-approval study investigating the potential of the therapy to prolong life and reduce the need for patient hospitalization.
The FDA granted the Barostim Neo System a Breakthrough Device designation, meaning the agency provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. All designated devices must meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.The FDA granted approval of the Barostim Neo System to CVRx Inc.
FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery
The U.S. Food and Drug Administration today approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves. These transcatheter valves – Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery. In low risk patients, open-heart surgery has been the standard-of-care for aortic valve replacement. However, the procedure to insert a transcatheter heart valve is less invasive, and involves a smaller incision and shorter recovery time than open-heart surgery. The FDA is the first medical products regulatory body in the world to expand the indication for these devices to patients at low risk for death or major complications associated with open-heart surgery.
“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “As the FDA assesses new medical technologies or expanded uses for previously approved products such as these, the agency remains committed to evaluating evidence from clinical trials and real-world clinical data in both the premarket and postmarket settings to ensure patients have access to high-quality, safe, and effective medical devices.”
The incidence of aortic valve stenosis increases with age. As the aortic valve opening narrows, the heart must work harder to pump blood to the body. Occurring in about 3% of Americans over age 75, severe aortic valve stenosis can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), cardiac arrest or death. Patients with severe aortic valve stenosis generally need to undergo heart valve replacement to improve blood flow through their aortic valve.
In a clinical study to evaluate safety and effectiveness, 503 patients with severe aortic stenosis at low risk for surgical complications were randomly selected to have aortic valve replacement with the Sapien 3 transcatheter heart valve, and 497 were randomly selected to have aortic valve replacement with traditional open-heart surgery using an approved surgical tissue valve. In a separate study, 734 low-risk patients with severe aortic stenosis were randomly selected to have aortic valve replacement with the CoreValve Evolut R or CoreValve Evolut PRO transcatheter valve, and 734 were randomly selected to have aortic valve replacement with traditional open-heart surgery using an approved surgical tissue valve.
At an average of 15-17 months follow-up, when outcomes (such as all-cause mortality or stroke) for transcatheter and surgical patients were compared, the transcatheter heart valve achieved comparable results to surgery, demonstrating a reasonable assurance of safety and effectiveness of the transcatheter heart valves in low surgical risk patients.
Like open-heart valve replacement surgery, treatment with transcatheter heart valves is associated with a potential risk of serious complications. The serious complications associated with the uses of these devices include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.
The transcatheter heart valves should not be used in patients who cannot tolerate blood thinning medications or have an active infection in the heart or elsewhere. Additionally, the CoreValve Evolut R and CoreValve Evolut PRO devices should not be used in patients who have sensitivity to titanium or nickel. Furthermore, the long-term durability of transcatheter heart valves compared to surgically implanted valves has not been established. Patients, especially younger ones, should discuss available treatment options with their heart care team to select the therapy that best meets their expectations and lifestyle.
These devices were approved using the Premarket Approval (PMA) pathway. Premarket approval is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).
As part of the approval of these devices, the FDA is requiring each manufacturer to continue to follow patients enrolled in their randomized studies for 10 years to further monitor transcatheter aortic valve safety and effectiveness, including the long-term valve durability. The manufacturers will also participate in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry to provide FDA with additional surveillance of these devices over a 10-year period.
The approval of the Sapien 3 and Sapien 3 Ultra was granted to Edwards Lifesciences LLC. The approval of the CoreValve Evolut R and CoreValve Evolut PRO was granted to Medtronic CoreValve LLC.