Respicardia Announces Enrollment Of First Patients In Pivotal Trial Of The remede® System For The Treatment Of Central Sleep Apnea
Successful Implants Have Been Performed At Numerous U.S. Sites
MINNEAPOLIS, Aug. 19, 2013 /PRNewswire/ -- Respicardia®, a developer of implantable therapies to improve respiratory and cardiovascular health, announced that the first patients have been enrolled in the pivotal trial to evaluate the remede system in patients with Central Sleep Apnea (CSA).
Dr. Rami Khayat enrolled the first patient at the Ohio State University Wexner Medical Center in Columbus, Ohio. Drs. Andrew Kao of Mid America Heart Hospital in Kansas City, Missouri and Steven Krueger of Bryan Heart Hospital in Lincoln, Nebraska enrolled additional patients at their respective centers.
"Central sleep apnea is a common problem that affects many heart failure and atrial fibrillation patients," said Dr. Khayat. "The remede system has the potential to offer an effective therapy for these patients using an implant, which requires no additional effort and is easily tolerated by the patient."
"At Mid America Heart Hospital, our heart failure, electrophysiology and sleep experts are collaborating to identify and treat CSA in our patient population," said Dr. Kao. "We are excited to participate in the Respicardia pivotal trial and offer a new therapy to our patients."
The Respicardia pivotal trial is a randomized, controlled study to compare the use of the remede System with medical therapy versus medical therapy alone. Patients will be enrolled at 25 centers in the United States with additional centers in Europe. Dr. Maria Rosa Costanzo, Medical Director of the Midwest Heart Specialists Heart Failure Program and the Edwards Center for Advanced Heart Failure in Naperville, IL, serves as international principal investigator.
Dr. Kruger, one of the leading enrollers in the pilot study, commented, "Having used the remede system in previous studies, we have gained a substantial appreciation for the positive effect that it has had on our patients. We are pleased to be part of the pivotal study and continue offering this therapy to our patients."
The results of the pilot study have been accepted for Late Breaking News presentation at the Heart Failure Society of America scientific sessions to be held in Orlando, Florida on Monday, September 23rd 2013.
About the remede System:
The remede System is an implantable pacemaker-like device that was designed for improved respiratory rhythm management. The remede 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 2006 and headquartered near Minneapolis, Minnesota, Respicardia is developing implantable therapies designed to improve respiratory and cardiovascular health. The company's initial product, the remede 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.
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