Following the procedure, the patients performed wireless measurements of their pulmonary artery pressure from home.
The wireless HF sensor is a proprietary miniature device that is implanted into the patient's pulmonary artery using a simple, catheter-based procedure. The pulmonary artery pressure is then measured and displayed using CardioMEMS' proprietary electronic monitoring system.
Following the procedure, the patients performed wireless measurements of their pulmonary artery pressure from home. The pressure data was immediately transmitted to a secure database and became available for review by the implanting physician on CardioMEMS' proprietary website. This data, as well as the pressure waveform, is also available to the physician on a PDA.
Dr. Mark Aaron, principal investigator of the Champion Study and Medical Director, Cardiac Transplant, Comprehensive Heart Failure and Transplant Program at Saint Thomas Hospital, says, "I was impressed by how easy it was to implant and use. Heart failure is the primary cause of hospitalization in the US, and I am hopeful the CardioMEMS sensor can reduce the number of hospitalizations and improve the quality of life of these patients by helping detect early warning signs of clinical decompensation."
Following the completion of the US feasibility study earlier this year, these patients represent the first enrolled in CardioMEMS' CHAMPION pivotal trial. The co-principal investigators of the CHAMPION pivotal trial are Philip Adamson, MD, director of the Heart Failure Institute, Oklahoma Heart Institute and William Abraham, MD, director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.
"These are the first CHAMPION study implants of this transformational technology," commented Jay Yadav, MD, chairman and CEO of CardioMEMS, Inc. "We are very pleased to collaborate with Dr. Aaron and Saint Thomas Hospital in the initiation of this US pivotal trial. Over the next several weeks, we expect to rapidly expand the number of hospitals that are part of this trial."
The Saint Thomas Research Institute is devoted to supporting the continual quest for new information to guide the practice of medicine. With the mindset that the discovery and application of new knowledge leads to providing the best care to our patients, the Saint Thomas Research Institute supports physicians' participation in broad-based, nationally recognized research initiatives and groundbreaking studies.
Saint Thomas Health Services is a faith-based ministry with more than 7,200 associates serving Middle Tennessee and consisting of four hospitals: Baptist and Saint Thomas Hospitals in Nashville, Middle Tennessee Medical Center in Murfreesboro and Hickman Community Hospital in Centerville.