MINNETONKA, Minn., Aug. 6, 2018 /PRNewswire/ -- Respicardia, Inc., a medical technology company developing innovative therapies that improve cardiovascular health, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved a New Technology Add-On Payment (NTAP) for the remedē® System. The remedē System is a first-of-its-kind implanted therapy that is clinically proven to reduce the severity of central sleep apnea, improve sleep and enhance patients' quality of life.1 The NTAP program recognizes innovative medical technologies that substantially improve the diagnosis or treatment of Medicare beneficiaries.
"We are very pleased that CMS recognizes the remedē System as a substantial clinical improvement in the available treatment options for Central Sleep Apnea," said Peter Sommerness, President and CEO of Respicardia. "We applaud the CMS NTAP program for its critical role in providing additional hospital reimbursement and improving patient access to innovative medical technologies like the remedē System."
Central Sleep Apnea (CSA) 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 a breakthrough, implantable system that treats the harmful effects of central sleep apnea by restoring a more normal breathing pattern during sleep.
The NTAP program will provide additional reimbursement on top of the standard Medicare Severity Diagnosis Related Group (MS-DRG) payment to hospitals paid under the Medicare Hospital Inpatient Prospective Payment System (PPS) and will become effective on October 1, 2018.
About the remedē® System
The remedē System is a transvenous, implantable neurostimulation system that causes the phrenic nerve to activate the diaphragm, restoring a normal breathing pattern during sleep in adult patients with moderate to severe CSA. The remedē System pivotal clinical trial, published in The Lancet, demonstrated that transvenous neurostimulation with the remedē System can significantly reduce the severity of CSA, improve sleep, and improve both quality of life and patient satisfaction. Recently published data in the American Journal of Cardiology demonstrates continued, long term efficacy of the therapy.2
The remedē System received U.S. Food and Drug Administration (FDA) approval in October 2017 and is commencing market release in a limited number of centers in the United States and Europe.
Respicardia is a leader in innovative technologies that address the unmet needs in respiratory and cardiovascular disease with safe and effective therapies. Founded in 2006 and headquartered near Minneapolis, Minn., Respicardia is dedicated to improving patient outcomes, quality of life and overall cardiovascular health via novel transvenous neurostimulation therapies. Learn more at www.respicardia.com.
1 Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82
2 Costanzo M, et al. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. Am J Cardiol. 2018. pii: S0002-9149(18)30258-3. doi: 10.1016/j.amjcard.2018.02.022.
SOURCE Respicardia, Inc.