“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.
The U.S. FDA has granted premarket approval for Transmedics Group Inc.’s OCS heart system for use with organs from donors after circulatory death (DCD). The approval expands on a prior FDA approval of the device for use with organs from donors after brain death in September 2021. Andover, Mass.-based Transmedics said its system can now be used for ex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death hearts.
The U.S. Centers for Medicare & Medicaid Services (CMS) has decided to leave the onus on Medicare administrative contractors (MACs) to make coverage determinations regarding the Allomap test for heart transplant rejection despite a request for a non-coverage policy. As was the case in the decision to allow MACs to determine coverage for total artificial hearts, the CMS said that the low annual rate of utilization of the Allomap, by Caredx Inc., of Brisbane, Calif., suggested that the MACs are in a better position to make the appropriate call regarding coverage.
TORONTO – Puzzle Medical Devices Inc. has been granted a U.S. FDA breakthrough device designation for a transcatheter heart pump designed for fragile patients with few minimally invasive options for treating advanced heart failure.
Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second quarter of 2021. The artificial heart offers a bridge to transplant in patients with end-stage biventricular heart failure. It provides an alternative for individuals for whom maximal medical therapy and left ventricular assist device are insufficient or contraindicated.
In the latest step toward making left ventricular assist devices (LVADs) easier and more accessible, the FDA recently approved a less invasive surgical approach for use with Abbott Laboratories’ latest LVAD, Heartmate 3. Now, rather than requiring risky open-heart surgery, the device can be implanted through an incision in the chest wall. Abbott gained Heartmate 3 in its 2017 acquisition of St. Jude Medical for $25 billion.