remedē system receives approval for commercial use
Respicardia has announced that the first U.S. commercial case using the remedē System to treat central sleep apnea was completed at The Ohio State University Wexner Medical Center in Columbus, Ohio by Ralph Augostini, MD, FACC, FHRS, Bob and Corrine Frick Chair in Cardiac Electrophysiology, Associate Professor of Medicine and co-director of the electrophysiology training program.
The first case coincides with the naming of seasoned medical device executive, Peter Sommerness, as CEO of Respicardia and leader of the remedē System U.S. launch.
"The remedē System is a breakthrough technology that uniquely treats central sleep apnea while greatly improving a patient's quality of life," stated Dr. Augostini. "I am proud to be a part of the system's first U.S. commercial case that has the potential to become the standard of care for these patients."
Central Sleep Apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health.
CSA results from the brain's inability to send appropriate signals to the respiratory muscles to stimulate breathing. The remedē System is clinically proven to safely and effectively treat moderate to severe CSA in adult patients and improve quality of life.
"Central sleep apnea is very common in cardiac patients, especially patients with heart failure, and is associated with a significantly greater risk for morbidity and mortality," explained William Abraham, MD, Professor of Internal Medicine and Chief of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center. "Being able to treat CSA offers a new hope to improve the quality of life for my patients."
In addition to its first U.S. commercial implant, Respicardia announces today that it has appointed Peter Sommerness as CEO. Mr. Sommerness brings 20 years of commercial and operational experience from the electrophysiology and cardiac rhythm management markets.
Most recently, Mr. Sommerness was a Partner at McKinsey and Company, where he was a leader in the global medical device practice, focusing on commercialisation strategies, product launches, and operational improvement initiatives.
Prior to this, he held the role of General Manager and Vice President of Cardiac Electrophysiology at Boston Scientific, where he was responsible for business unit strategy, portfolio and commercial execution.
"I'm excited to join Respicardia and its seasoned team at such a pivotal moment," stated Mr. Sommerness. "With the major milestone of our first U.S. commercial implant, I look forward to building on this momentum in the U.S. market and to bringing this groundbreaking technology to patients suffering from the harmful effects of central sleep apnea."