The self-expanding A-Flux device is implanted in the coronary sinus to increase pressure on the venous side of the heart and improve perfusion in smaller vessels.
Philips is recalling all sizes of its Tack Endovascular System after 20 patient injuries were reported. Interventional cardiologists are urged to stop using the device immediately.
The American College of Cardiology and American Heart Association published the new guidelines with assistance from other leading U.S. medical societies.
The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.
The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting.
Follow-up care after a successful heart transplant can be challenging—both for providers and their patients. Consider, for example, the fact that so many patients who develop complications never actually present with symptoms.
