Miami, FL – February 20, 2008 - Mercy Hospital announced that it has enrolled its first patient into a clinical trial of a wireless pressure sensor for heart failure (HF) patients on January 15, 2008. The implant was performed under the direction of Javier Jimenez, M.D., principal investigator and director of the Miami Center for Cardiovascular Disease. This patient is the first in Miami to be enrolled into the Mercy Research Institute’s CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) pivotal clinical study. This trial will study the safety and effectiveness of the HF Pressure Measurement System in reducing HF-related hospitalizations in HF patients.
The wireless heart failure sensor is a proprietary miniature device designed and developed by CardioMEMS, Inc. The sensor is implanted into the patient’s pulmonary artery using a simple, catheter-based procedure. The patients use proprietary electronics to wirelessly collect pulmonary artery pressure measurements from the implanted sensor while the patient is at home. The pressure data is immediately transmitted to a database and is available for review on a secure website by the implanting physician. This data, as well as the pressure waveform, is also available to the physician on a PDA. The trial will study whether this data can be used by physicians to help determine the appropriate medical treatment, and if this might result in a reduction in hospitalizations for heart failure patients.
“A new concept in the care of heart failure patients has emerged by combining nanotechnology and telemedicine. This technology allows unprecedented monitoring of in-vivo data anywhere and anytime,” stated Dr. Jimenez.
Following the completion of a U.S. feasibility study earlier this year, the CHAMPION pivotal study of this promising new technology was initiated in September 2007. The Co-Principal Investigators of the CHAMPION pivotal trial are Philip Adamson, M.D., director of the Heart Failure Institute, Oklahoma Heart Institute and William Abraham, M.D., director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.
“The Heart Center at Mercy Hospital is among the most technologically advanced in the country. Participation in this revolutionary clinical trial is just another example of Mercy Hospital providing its patients with the latest in medical technology. CardioMEMS is very pleased to be collaborating on the CHAMPION trial with Dr. Jimenez and his staff at Mercy Hospital,” said Jay Yadav, M.D., chairman and CEO of CardioMEMS, Inc.
###
About Mercy Hospital
Mercy Hospital, a recipient of the prestigious Magnet™ award for nursing excellence, is Miami-Dade’s only Catholic Hospital. Established in 1950, it is sponsored by the Sisters of St. Joseph and a member of Catholic Health East. A 483-bed acute care hospital, staffed by over 700 physicians representing 27 medical specialties, its Centers of Excellence include: The Heart Center at Mercy Hospital, the Miami Cancer Center at Mercy Hospital, the Orthopaedic Institute at Mercy Hospital, and the Minimally Invasive Surgical Institute at Mercy Hospital. Mercy Hospital is located at 3663 S. Miami Avenue, Miami, FL.
About CardioMEMS,Inc.
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 radio frequency, 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. CardioMEMS is a trademark of CardioMEMS, Inc.
For more information contact:
Arianne Rey
(305) 860-4634
Yvette Rodriguez
(305) 663-3543
