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."