The US Food and Drug Administration (FDA) has approved Respicardia’s transvenous implantable neurostimulation system, remedē, for moderate to severe central sleep apnea (CSA) in adults.
remedē is designed to activate the phrenic nerve and engage the diaphragm to restore natural breathing during sleep by creating negative pressure that moves air into the lungs.
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As the system delivers automatic and continuous therapy throughout the night, it eliminates the need for external equipment.
Respicardia president and CEO Bonnie Labosky said: “This is a significant step forward in our efforts to offer clinicians a breakthrough and effective treatment option for their patients with CSA.”
The FDA approval is based on the results obtained from the prospective, multi-centre, randomised, controlled remedē system pivotal trial that assessed the safety and effectiveness of the implanted system in 151 patients at 31 sites in the US and Europe.
The primary effectiveness outcome of the trial was the proportion of patients who achieved a reduction in apnea-hypopnea index (AHI) of 50% or above from baseline to six months, compared to the control group.
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By GlobalDataThe results indicated that transvenous phrenic nerve stimulation significantly decreased CSA severity, improved sleep, and quality of life with therapy satisfaction for 96% of the participants.
Respicardia intends to initially carry out a limited release of the remedē System, with plans for expansion to broader market commercialisation.
