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FDA Panel Votes Against CardioMEMS Device


12/9/2011 7:02:24 AM

ATLANTA, Dec. 8, 2011 /PRNewswire/ -- CardioMEMS announced today that the U.S. Food and Drug Administration's (FDA) Circulatory Systems Devices advisory panel voted against the Champion Heart Failure Monitoring System, the first wireless, permanently implantable device that allows cardiologists to monitor heart failure patients from their homes. While the panel agreed that the CardioMEMS technology is safe with a vote of 9-1, the majority did not vote positively that the System is effective and that reasonable assurance of the risks associated with the device outweigh the potential clinical benefits of the technology.

Today's committee recommendation, although not binding, will be considered by the FDA as it reviews the pre-market approval application for the Champion HF Monitoring System. CardioMEMS submitted a modular pre-market approval (PMA) application with the last submission completed in April 2011 based on data from its CHAMPION clinical trial.

CardioMEMS CEO and Founder, Jay Yadav, MD commented, "While we are disappointed with today's outcome, we look forward to continuing discussions with the FDA to determine the best path forward. We believe this technology is a significant step forward in the management of heart failure patients."

The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial demonstrated a 28% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 37% reduction in heart failure hospitalization rates at 15 months for heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor, compared to control patients receiving standard heart failure treatment. The CHAMPION Trial met all of its safety and secondary efficacy endpoints.

For more information on the CHAMPION trial or CardioMEMS, please visit our website at www.cardiomems.com

About CardioMEMS, Inc.

CardioMEMS is a medical device company that has developed and is commercializing proprietary wireless sensing and communication technology for the human body. The Company's technology platform is designed to improve the management of severe chronic cardiovascular diseases such as aneurysms, heart failure and hypertension. CardioMEMS 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. The 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 energy, the sensors transmit real-time data to external electronic readers, which then communicate this information to the patient's physician. The Company developed this technology based on the belief that 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. More information about the CardioMEMS is located 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 perceived or actual advantages 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, Champion and the CardioMEMS logo are registered trademarks of CardioMEMS, Inc.

Caution: The Champion Heart Failure Monitoring System is an investigational device limited by federal law to investigational use.

For more information on the CHAMPION trial or the CardioMEMS Heart Failure Management System, please visit the company's website at www.cardiomems.com.

SOURCE CardioMEMS, Inc.



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