MINNEAPOLIS, MN – April 30, 2013 – Respicardia, Inc., a developer of implantable therapies to improve respiratory and cardiovascular health, announced it has received approval from the United States Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to initiate the pivotal trial – a randomized trial evaluating the safety and effectiveness of the remedē System in patients with Central Sleep Apnea (CSA).
Dr. Maria Rosa Costanzo, Medical Director of the Heart Failure Program with Midwest Heart Specialists-Advocate Medical Group and Medical Director of the Edward Center for Advanced Heart Failure in Naperville, Illinois, will serve as principal investigator of the trial.
“There is a significant unmet clinical need for effective solutions to treat patients with CSA,” said Dr. Costanzo. “Previous studies have demonstrated statistically significant clinically meaningful improvements in sleep and respiration using the remedē system and I am very excited to lead this very important trial” (Ponikowski et al. EHJ 2012).
“The FDA approval to begin the pivotal trial marks a significant milestone for the Company and is the next step on our path to improving the outcome for patients with CSA,” said Bonnie Labosky, President and CEO for Respicardia. “I am especially pleased that we were able to receive this timely approval on our initial submission. This will continue to support Respicardia’s positive momentum and progress.”
Respicardia plans for immediate enrollment of patients with moderate to severe CSA in its pivotal trial. The trial will study the safety and effectiveness of the remedē system for the treatment of CSA. The trial will enroll up to 173 patients at 25 centers in the United States with additional centers in Europe.
About the remedē® System:
The remedē system is an implantable pacemaker-like device that was designed for improving CSA using Respidrive™, a Respiratory Rhythm Management™ algorithm. The remedē system delivers electrical pulses via a proprietary, novel transvenous implantable lead to one of the body’s two phrenic nerves. The remedē system therapy is intended to stimulate the diaphragm to restore a more natural, less disrupted, breathing pattern.
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.
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)