CardioMEMS has declared that the advisory panel of the Circulatory System Devices division from US Food and Drug Administration (FDA) voted against the first wireless, implantable CHAMPION pressure sensing unit for heart failure patients, which assists the cardiologists at their homes to monitor patients having heart diseases.
Even though the advisory panel vote of 9-1 confirmed that the CardioMEMS technology solutions are safe, the majority did not vote for this technology since the significant risk associated with the monitoring unit is definitely more than its benefits in clinical sector. The company had applied for a modular pre-market approval (PMA) with the latest submission filed in April 2011, based on the CHAMPION clinical trial’s information.
Jay Yadav, Managing Director, Founder and Chief Executive Officer of CardioMEMS, stated that even though the majority of panel members did not vote for the company’s technology, the company will continue its discussion with the FDA in identifying how to proceed with the technology. Yadav also commented that this permanently implantable technology is a breakthrough innovation in heart failure patient management. According to the clinical trial of CHAMPION, 28% and 37% of reduction in the hospitalization rates of the patients having heart failure was achieved, whose treatment was monitored using a compact, wireless implantable sensor, for a period of 6 and 15 months respectively when compared to the hospitalization rates of the patients treated using standard traditional methods.
Source: https://www.abbott.com/