ATLANTA, Sept. 13, 2007 (PRIME NEWSWIRE) -- CardioMEMS, Inc. today announced that its wireless pressure sensor for heart failure (HF) monitoring was successfully implanted in two patients at Saint Thomas Hospital, Nashville, Tennessee under the direction of Mark Aaron, MD, Medical Director, Cardiac Transplant, Comprehensive Heart Failure and Transplant Program, St. Thomas Heart Institute. These patient implants mark the initiation of the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) pivotal clinical study.
The wireless HF sensor is a proprietary miniature device which 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. Aaron commented "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 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."
CardioMEMS is a medical device company that has developed and is commercializing a proprietary wireless sensing and communication technology for the human body. Our technology platform is designed to improve the management of severe chronic cardiovascular diseases such as aneurysms, heart failure and hypertension. Our miniature wireless sensors can be implanted using minimally-invasive techniques and transmit cardiac output, blood pressure and heart rate data which are critical to the management of patients. Our sensors are designed to be permanently implanted into the heart and blood vessels due to their small size, durability, and lack of wires and batteries. Using radiofrequency, or RF, energy, our sensors transmit real-time data to external electronic readers which then communicate this information to the patient's physician. We believe frequent, on-demand, real-time monitoring of vital information enables proactive patient management, which holds the promise of reducing hospitalizations, improving a patient's quality of life and delivering more efficient and cost effective health care.
CardioMEMS is located in Atlanta, GA and is privately held. More information about the company can be found at www.cardiomems.com.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and benefit of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward-looking statements.
CardioMEMS is a trademark of CardioMEMS, Inc.
CardioMEMS Bud Ingalls, CFO 678-651-2300