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Bonnie Labosky, President and CEO of Respicardia reported, “We believe the remedē® System will soon become the treatment of choice for patients suffering from central sleep apnea and are pleased to receive significant funding from ZOLL in support of this important mission.” She added, “Proceeds from the financing will be used to fund our U.S. commercialization efforts and support ongoing development of the system.”
The company reports that Central Sleep Apnea is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health. CSA results from the brain’s inability to send appropriate signals to the respiratory muscles to stimulate breathing. The remedē System is clinically proven to safely and effectively treat moderate to severe CSA in adult patients and improve quality of life.
Jonathan A. Rennert, CEO of ZOLL notes, “The remedē System is a breakthrough technology that uniquely treats the devastating effects CSA has on a person’s quality of life and cardiovascular health.” On the investment, Rennert said, “This investment in Respicardia exemplifies ZOLL’s commitment to advance novel therapies, especially those that address heart failure or one of its many co-morbidities such as central sleep apnea.”
The remedē System is a transvenous implantable neurostimulation system that stimulates the phrenic nerve, and engages the diaphragm to restore a normal breathing pattern during sleep in patients with CSA. The remedē System pivotal trial, published in The Lancet, demonstrated that transvenous neurostimulation with the remedē System can significantly reduce the severity of CSA, improve sleep, quality of life and patient satisfaction.
The remedē System received U.S. Food and Drug Administration (FDA) approval in October of 2017 and is commencing market release of the system in the United States.