Navigation Links
FDA Advisory Panel Recommends Against Approval of Champion® Heart Failure Management System for Patients With Heart Failure

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

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

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

Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
2. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
3. Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Review of its Phase 1/2 Trial of tgAAC94 for Rheumatoid Arthritis
4. Schiffrin Barroway Topaz & Kessler, LLP and Janet Jenner & Suggs, LLC Comment on Conagra Advisory Regarding Pot Pies Linked to Salmonella Outbreak
5. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
6. FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
7. HUYA Bioscience Intl Announces World-Class Clinical Advisory Team for New Anti-Arrhythmic Compound Sourced From China
8. FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
9. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
10. UBC Forms European Advisory Board to Enhance Data Quality of CNS Trials
11. FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
Post Your Comments:
(Date:11/27/2015)... , November 27, 2015 ... set to go online. The potential to save costs, ... vast and far from fully exploited as yet. Here, ... health records, either via mobile tablet or directly at ... --> ) -->      ...
(Date:11/27/2015)... Niederlande, November 27, 2015 ... bei fortgeschrittenem Krebs.   --> Ein ... fortgeschrittenem Krebs.   --> Ein ... fortgeschrittenem Krebs.   Clinical Cancer Research ... Clinical Cancer Research vom 6. November ...
(Date:11/27/2015)... , Nov. 27, 2015  Lannett Company, Inc. ... has completed the acquisition of Kremers Urban Pharmaceuticals ... of global biopharmaceuticals company UCB S.A. (Euronext: UCB). ... Lannett has acquired KU from UCB for total ... adjustments, including a customary working capital adjustment, a ...
Breaking Medicine Technology:
(Date:11/27/2015)... Raleigh, NC (PRWEB) , ... November 27, 2015 , ... ... most effective ways to treat it. Surviving Mesothelioma has just posted the findings ... Researchers at University Hospital Zurich analyzed the cases of 136 mesothelioma patients who were ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, from ... dispense prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. , ... prescription medications. In doing so, it could help to prevent potential overdose situations. ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... filthy the toilets were," said an inventor from Hillside, N.J. "Many people catch ... seat cover so that individuals will always be protected from germs." , He ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... Lizzie’s ... , The company is offering customers 10% off of their purchase of lice treatment ... treatment at full price. According to a company spokesperson. “Finding lice is a sure ...
(Date:11/27/2015)... ... , ... The print component of “Supporting Our Caregivers” is ... York, Minneapolis, South Florida, with a circulation of approximately 250,000 copies and an ... social media strategy and across a network of top news sites and partner ...
Breaking Medicine News(10 mins):