|By PR Newswire||
|March 12, 2014 07:03 AM EDT||
MINNEAPOLIS, March 12, 2014 /PRNewswire/ -- Respicardia®, Inc., a developer of implantable therapies to improve respiratory and cardiovascular health, announced that it has been awarded the Best Innovation of 2014 from Cardiovascular Research Technologies (CRT) and CV Pipeline for the remedē® System, the first and only implantable device for the treatment of central sleep apnea.
"Central sleep apnea (CSA) is associated with increased mortality and hospitalization and can affect nearly half of all heart failure patients and one-third of atrial fibrillation patients," stated Dr. Robin Germany, Chief Medical Officer of Respicardia. Kris James, a developer of the remedē System, further notes that "the System is a fully implantable transvenous neurostimulation technology designed to stabilize CO2 levels and restore normal sleep and breathing to patients with CSA."
The remedē System has received CE mark in Europe and is currently being evaluated in an FDA approved pivotal trial at 25 centers in the U.S., with additional centers in Europe. Results from the pilot study showed statistically significant and clinically meaningful improvements in sleep parameters at 6-month follow-up. Patients experienced a greater than 50% decrease in apnea-hypopnea index (AHI), improved oxygenation by over 50%, decreased arousals and improved quality of life.
"It was a pleasure to participate in this year's Cardiovascular Innovation Award competition at CRT," stated Bonnie Labosky, President and CEO of Respicardia. "With more than 30 unique technologies considered, we are pleased that the remedē System was selected as the Top Innovation of 2014. This award highlights our efforts to develop a highly innovative and effective treatment of restoring cardiovascular health for patients with CSA."
About the remedē® System:
The remedē System is an implantable pacemaker-like device that was designed for improved respiratory rhythm management. The remedē System delivers electrical pulses via an implantable lead to one of the body's two phrenic nerves. The diaphragm responds by restoring a more natural, less disrupted, breathing pattern.
About Central Sleep Apnea:
Central sleep apnea is a type of sleep-disordered breathing that disturbs the normal breathing pattern during sleep and adversely affects 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 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.
Founded in late 2006 and headquartered near Minneapolis, Minnesota, Respicardia is developing implantable therapies designed to improve respiratory and cardiovascular health. The company's initial product, the remedē System, is an implantable stimulation device designed to restore a more regular breathing pattern during sleep for central sleep apnea patients.
For more information please visit www.respicardia.com
SOURCE Respicardia, Inc.