FDA Approves Sleep Apnea Implant Treatment

first_img The U.S. Food and Drug Administration has approved a new treatment option for patients with moderate to severe central sleep apnea—and it won’t leave you with unsightly CPAP mask marks.The Remedē System is an implantable device that stimulates a nerve in the chest responsible for sending signals to the diaphragm to stimulate breathing.A common disorder that causes pauses in breathing or shallow breaths while snoozing, sleep apnea leaves patients tired, and can increase the risk of high blood pressure, heart attack, stroke, obesity, diabetes, and heart failure.AdChoices广告Aside from various lifestyle changes (weight loss, quitting smoking) or surgery, the prevailing treatment is a CPAP (continuous positive airway pressure) machine, which requires a mask be worn on the mouth and nose.But perhaps even worse than sleep apnea itself are the lines and creases covering the wearer’s face the next morning.The Remedē System implant stimulates breathing in sleep apnea patients (via FDA)Enter Remedē System: The battery-powered pulse generator sits under the skin in the upper chest, connected to thin wires threaded through veins near the phrenic nerve. Small electrical stimulus—programmed using an external controller—make the diaphragm muscle contract, causing the user to take a breath.Two modes allow the patient (or, more likely, the physician) to set the system to generate pulses at a fixed rate (asynchronous therapy) or only when it detects a pause in breathing (synchronous therapy).“This implantable device offers patients another treatment option for central sleep apnea,” according to Tina Kiang, acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices in the FDA’s Center for Devices and Radiological Health.In a six-month clinical trial of 141 adult patients, more than half of people with the Remedē System reported at least 50 percent reduction in frequency and severity of apnea episodes, versus 11 percent in a control group (sans an active implant).There is no word on the new treatment’s availability or pricing (for reference, CPAP machines range from $200 to upwards of $2,000). It is also unclear whether the implant is be a one-time procedure, or needs to be replaced every so often.The FDA did not immediately respond to Geek’s request for comment.Let us know what you like about Geek by taking our survey. New AI Tool Can Help Doctors Detect Brain AneurysmsFDA Approves First New Major Depression Drug in Decades Stay on targetlast_img read more

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