The FDA’s Circulatory System Devices Panel will meet over 2 days next week to discuss potential reclassification of 3 cardiovascular assistance devices, according to a note in the Federal Register.
The technologies up for review are external counter-pulsating devices, intra-aortic balloon pump systems and nonroller-type cardiopulmonary bypass blood pumps.
The FDA initially issued Class III labeling on all 3 devices on March 9, 1979, when panelists at the time deemed the devices potentially dangerous, even when used properly. The panel will revisit the devices over 3 sessions on December 5 and 6, according to a notice.
The panel’s schedule breaks down as follows:
December 5, Session 1
The panel will consider reclassification of external counter-pulsating devices, generally comprised of a cuff and a controller, which provide non-invasive circulatory support by alternating pressure on the lower extremities.
The panel originally issued Class III labeling on ECP devices because the devices could be "potentially hazardous to life or health even when used properly" and because panelists felt there was not sufficient information to assure the devices were safe and effective in general.
December 5, Session 2
The panel will review classification for intra-aortic balloon pumps, generally comprised of an inflatable balloon and a control console that alternates pressure from inside the heart to assist the left ventricle as it pumps blood through the aortic valve.
Panelists in 1979 had deemed the devices were difficult to use safely and effectively, and stated that "controversy exists as to whether the device is beneficial in many situations in which it is used."
December 6
The panel will reconsider classification of cardiopulmonary bypass blood pumps, including external devices and those temporarily implanted in the heart to provide pumping support.
The original Class III labeling for these devices was based on the panel’s decision that "premarket approval was necessary to assure the safety and effectiveness of the device."
The FDA plans to make more background materials available prior to the meeting, according to the report. Interested parties are welcome to send their perspectives in writing prior to the meeting or schedule an oral presentation during next week’s meetings.