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"Patients with advanced heart failure have limitations in physical activity, fatigue, palpitations or shortness of breath and can not benefit from standard treatments, including medications and devices. currently marketed. This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure, "said Bram Zuckerman, MD, director of the Office of Cardiovascular Devices at the FDA's Center for Devices and Radiation Health. "The FDA continues to work with manufacturers on its breakthrough device program to provide patients and healthcare providers with rapid access to medical devices that can lead to clinical improvement in patients, such as: those suffering from this irreversibly debilitating disease, while ensuring that these devices meet our regulatory requirements for safety and effectiveness. "
In the United States, about 5.7 million people suffer from heart failure, a condition in which the heart can not pump enough blood to meet the needs of the body. The main causes of heart failure are diseases that damage the heart, such as high blood pressure and diabetes. The treatment of heart failure includes the treatment of underlying causes and the reduction of symptoms such as fatigue and swelling of the lower extremities that make physical activity difficult. Doctors may prescribe medications such as angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor antagonists or beta-blockers to reduce blood pressure and reduce pressure on the heart, as well as diuretics to reduce the accumulation of fluid in the lungs and swelling of the feet and ankles.
The Barostim Neo system includes a pulse generator implanted under the clavicle and connected to a probe that attaches to the carotid artery of the neck. Once the device is implanted, a doctor tests it and the program. The latter provides electrical impulses to the cells of the neck, called baroreceptors, which detect the circulation of blood in the carotid arteries and transmit the 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 the symptoms of heart failure.
The Food and Drug Administration has evaluated data from a multicenter, prospective, prospective, randomized clinical trial involving 408 patients with advanced heart failure. All patients received medical treatment according to the guidelines, including medication, and 125 patients also received a Barostim Neo System implant. Patients receiving the implant showed an improvement in walking distance during six-minute walk tests and the impact of symptoms on their quality of life. Also in the trial, 102 randomized subjects with less severe chronic heart failure have found a benefit in lowering the levels of a biomarker measuring heart failure.
Potential complications associated with the implantation or use of the device include: infection; need reoperation; hypotension which may cause dizziness, fainting and / or falls; nervous damage; surgical or anesthetic complications; allergic reaction; arterial damage; exacerbation of heart failure; stroke; And the dead.
The Barostim Neo System is indicated for patients who have a regular heart rhythm, who are not candidates for cardiac resynchronization treatment and whose left ventricular ejection fraction (the total amount of blood pumped at each heartbeat) ) is 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 may impair its implantation, certain disorders of the nervous system, a slow and uncontrolled and symptomatic heart rate, atherosclerosis or ulcerative plaques in the vicinity of the patient. Location of the implant and to patients with known allergy to silicone or titanium.
The device has been approved using the pre-market approval (PMA) process. Pre-market approval is the most stringent type of marketing application required by the Food and Drug Administration. It relies on the Food and Drug Administration's determination that EMP's application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective. for its intended use.
As part of the approval of this device, the Food and Drug Administration is asking the manufacturer to conduct a post-approval study to investigate the potential of the treatment to prolong life and reduce the need for it. hospitalization of the patient.
The FDA has awarded the Barostim Neo system a revolutionary device designation, which means that the agency has provided extensive interaction and advice to the company for efficient device development to speed up the production of evidence. and the revision of the device by the agency. To qualify for this designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly disabling condition or condition. All designated appliances must meet one of the following criteria: the appliance must represent state-of-the-art technology; there must be no approved or authorized alternative; the device must offer significant advantages over existing approved or authorized alternatives; or the availability of the device is in the best interest of patients.
The Food and Drug Administration has approved the approval of the Barostim Neo System at CVRx Inc.
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