Significant Data to Expedite Pivotal Clinical Trial of Groundbreaking Medical Device
Minneapolis, Minn. – October 29, 2012 – Respicardia®, a developer of implantable therapies to improve respiratory and cardiovascular health, announced the end of 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. “Now that we have implanted the device in over 45 patients and completed enrollment, we have gathered more than sufficient data to move forward with the pivotal trial,” said William T. Abraham, M.D., professor of internal medicine and director of cardiovascular medicine at The Ohio State University, and co-principal investigator of the global pilot study. “Clinicians are now one step closer to being able to offer patients a reliable and safe option to treat central sleep apnea.”
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.”
About Central Sleep Apnea
Central sleep apnea disturbs the normal breathing pattern during sleep and has an adverse effect on overall cardiovascular health. The disease occurs when the brain does not send the correct signals to the diaphragm and can lead to excessive daytime sleepiness, reduced exercise capacity, and irregular or very fast heart rhythms (arrhythmia). CSA is common among patients with heart failure, affecting approximately 40 percent, can lead to the worsening of heart failure and is associated with an increased risk of death.
About Cardiac Respicardia®:
Founded in 2006 and headquartered near Minneapolis, Minnesota, Respicardia® is dedicated to developing implantable therapies designed to improve the respiratory and cardiovascular health of patients. The company’s initial product, the remedē® System, is an implantable stimulation device that is designed to restore a more regular breathing pattern during sleep for patients with central sleep apnea. For more information on the company and participation in its upcoming pivotal clinical trial, please visit www.respicardia.com.
Name: Jill Hoffman, Communications Consultant (for Respicardia)
Address: 12400 Whitewater Drive, Suite 150, Minnetonka, MN 55343
Telephone: 310-205-9930 (office)
Telephone: 323-719-7111 (cell)