Respicardia® Receives FDA Approval to Begin the Pivotal Trial of the remede® System for the Treatment of Central Sleep Apnea
MINNEAPOLIS, April 30, 2013 /PRNewswire/ — 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 remede 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 remede 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 remede 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 remede® System:
The remede System is an implantable pacemaker-like device that was designed for improving CSA using Respidrive(TM), a Respiratory Rhythm Management(TM) algorithm. The remede System delivers electrical pulses via a proprietary, novel transvenous implantable lead to one of the body’s two phrenic nerves. The remede System therapy is intended to stimulate the diaphragm to restore a more natural, less disrupted, breathing pattern.
About Central Sleep Apnea:
CSA is a type of sleep disordered breathing that 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 may lead to excessive daytime sleepiness, reduced exercise capacity, and irregular or very fast heart rhythms (arrhythmia). CSA affects up to 40% of heart failure patients and 30% of atrial fibrillation patients and is associated with the worsening of heart failure and an increased risk of death (Brenner 2008 Trends Cardiovasc Med).
Founded in 2006 and headquartered near Minneapolis, Minnesota, Respicardia, Inc. is developing implantable therapies designed to improve respiratory and cardiovascular health. Respicardia received CE Mark for the remede System in patients with periodic breathing in August 2010. The remede System is not currently approved by the U.S. Food and Drug Administration for use in the United States.
For more information, please visit www.respicardia.com.
SOURCE Respicardia, Inc.