Minneapolis-based Respicardia said it launched a pivotal clinical trial of its Remede implantable device for central sleep apnea.
The pacemaker-like implant is designed to relieve sleep problems experienced by many heart failure and atrial fibrillation patients. It’s designed to send regular electrical impulses to the phrenic nerves, to prompt a response from the diaphragm.
The trial will have 2 arms, pitting Remede plus medical therapy against medical therapy alone. Heart patients frequently suffer from sleep apnea, which is associated with increased chances of heart failure and death, according to a press release.
Patients enrolled at medical centers in Columbus, Ohio, Kansas City, Mo., and Lincoln, Nebr. Ultimately, the trail will extend to 25 centers in the U.S. and some in Europe, according to the release.