Zoll Medical Corp has acquired Respicardia Inc, a provider of novel implantable neurostimulators for the treatment of moderate to severe central sleep apnea (CSA).
Respicardia’s remedē System is a is the only implantable device approved by the US FDA to treat moderate to severe CSA in adult patients with reduced cardiac function.1 CSA results in shallow or disrupted breathing during sleep, and many patients with CSA also have heart disease, especially heart failure.2 Within this population, patients with CSA are at increased risk for hospitalizations and even death.3,4
“Zoll and Respicardia both develop innovative therapies for conditions with large unmet clinical needs, and we share a deep commitment to improving patient outcomes,” said Jon Rennert, CEO of Zoll Medical. “With this acquisition, Zoll will combine its expertise in cardiac and respiratory care with Respicardia’s novel remedē System to make a meaningful difference in the health and quality of life for many patients.”
CSA occurs when the brain fails to send appropriate signals to the breathing muscles that stimulate a regular breathing pattern. CSA symptoms include chronic fatigue, excessive daytime sleepiness, cognitive impairment and inability to get restful sleep. CSA is distinct from Obstructive Sleep Apnea (OSA), which results from a blockage of the upper airway.5
Respicardia’s remedē System is implanted by a cardiac electrophysiologist during a minimally invasive outpatient procedure. The remedē® System delivers electrical pulses to one of the phrenic nerves, which send signals to the diaphragm, restoring a more normal breathing pattern during sleep. Respicardia estimates there are more than one million CSA patients in the US alone who could benefit from the remedē System,6 which has been shown to improve sleep, enhance well-being, and reduce daytime sleepiness, enabling better overall health.7
Zoll, which has been a significant investor in Respicardia for more than three years, will welcome all Respicardia employees into its global workforce, and will maintain Respicardia’s current headquarters in Minnetonka, Minnesota.
1 FDA PMA P160039
2 Bekfani T, Abraham WT. Europace. 2016 Aug;18(8):1123-34. doi: 10.1093/europace/euv435. Epub 2016 May 26.
3 Khayat R et al. Central sleep apnea is a predictor of cardiac readmission in hospitalized patients with systolic heart failure. J Card Fail 2012;18:534–40.
4 Khayat, R et al. Sleep disordered breathing and post-discharge mortality in patients with acute heart failure, European Heart Journal 2015;36 1463–1469.
5 Costanzo M.R., Khayat R., Ponikowski P., et al. Mechanisms and clinical consequences of untreated central sleep apnea in heart failure. J Am Coll Cardiol. 2015; 65:72–8
6 Javaheri and Dempsey, Comprehensive Physiology 2013; 3:141-163; Dymedex data on file, 2014
7 Costanzo M, et al. Transvenous neurostimulation for central sleep apnea: a randomised controlled trial. The Lancet. 2016; 388: 974–82