The EVAHEART 2 is an Investigational Device limited by US FDA to Investigational Use only.
Methodist Hospital is the first facility in the nation to implant a newly designed cardiac mechanical pump, EVAHEART®2, on a patient with severe heart failure on the COMPETENCE Trial. The implant was performed by Masahiro Ono, MD, Heart Transplant Surgeon and Michael Kwan, MD, Advanced Heart Failure and Transplant Cardiologist on December 15, 2020.
This newly–designed cardiac assist device is an alternative to transplantation and is intended to help patients with severe heart failure, whose hearts are unable to pump enough blood to support their normal activities or to sustain life. The main components of this device include a blood pump (inside the body), a controller (outside the body), and a driveline cable that connects the blood pump to the controller.
This procedure was part of a multi-center clinical trial for the evaluation of a left ventricular assist device (VAD). The COMPETENCE Trial will include 40 VAD clinical sites with 399 patients enrolled through 2022.
“The opportunity to contribute to a much larger population by being among the very first in the country to use a new LVAD technology is truly exciting and puts Methodist at the very forefront of LVAD therapy,” commented Dr. Kwan. “This demonstrates the commitment of the entire Methodist team to bringing the very best to our patients most in need and ensures medical progress and breakthroughs continue despite the COVID pandemic.”
Methodist Hospital is among five active sites in the recently launched clinical trial. This achievement affirms the strength in the hospital’s commitment to providing quality care and ensuring patients remain at the forefront of the hospital’s mission. Methodist Hospital’s expert heart failure care expands beyond just ventricular assist device (VAD) implantation; they are also a regional leader in heart transplantation, having recently performed their 500th transplant. To date, the Advanced Heart Failure program averages 25 heart transplants and 20 VADs annually.