Respicardia, a developer of implantable therapies to improve respiratory and cardiovascular health, has ended enrollment in the first global pilot study to treat central sleep apnea (CSA) with an implantable system, exceeding the 45-patient milestone. The remedē System, which received CE Mark approval in 2010, delivers electrical pulses during sleep to restore a more normal breathing pattern in patients with CSA. As of this milestone and completion of its pilot study, Respicardia can proceed with the protocol for its pivotal trial. “Completion of over 45 successful implants in the pilot study is a major accomplishment for the company,” said Bonnie Labosky, CEO of Respicardia. “Results from this pilot study give us confidence in moving forward quickly with our pivotal study.”
The remedē System is a pacemaker-like device that delivers electrical pulses via an implantable lead to one of the body’s two phrenic nerves, to which the diaphragm responds by restoring a more natural, less disrupted breathing pattern.
The pilot study included candidates 18 years of age and older with known recent histories of CSA. “The data collected from these patients validates the remedē System as a novel therapy for treating a large and growing health problem,” said Prof Piotr Ponikowski, the co-principal investigator of the pilot study at The Medical University/4th Military Hospital in Wroclaw, Poland. “The technology has the potential to revolutionize the way we treat patients with central sleep apnea, both with and without heart failure, as well as improve immeasurably the quality of life for these patients.”