First Person in the Nation Receives HeartMate II LVAS for Permanent Heart Support

Strategic Insights -

A 72-year-old man from Chicago has made history as the first person in the nation to receive the HeartMate II LVAS for ongoing, permanent support of his failing heart. Developed by Thoratec Corporation, the device is a groundbreaking innovation in the treatment of heart failure, offering a smaller and more efficient alternative to existing FDA-approved devices. The national pivotal trial, which involves 200 patients and 40 sites, aims to determine the safety and efficacy of the HeartMate II as Destination Therapy in late-stage heart failure patients. A separate arm of the study will evaluate the device as a bridge-to-transplant for patients awaiting a heart transplant.

Key Takeaways:

  • The HeartMate II LVAS, developed by Thoratec Corporation, is a small device measuring just over 3 inches long and 1.75 inches in diameter, making it significantly smaller than existing FDA-premarket approval devices.
  • The national pivotal trial will involve 200 patients and 40 sites, randomizing the HeartMate II to the HeartMate XVE LVAS to determine safety and efficacy as Destination Therapy.
  • The study will also evaluate the HeartMate II as a bridge-to-transplant (BTT) device for 133 patients at up to 25 sites.
  • Mark Slaughter, director of the mechanical assist device program at Christ Medical Center, led the team that implanted the device in the Chicago patient during a 4-hour operation on March 21.
  • Advocate Christ Medical Center is the only center in Illinois with the innovative HeartMate II device for heart failure treatment.
  • The HeartMate II is the first device to offer permanent support for heart failure patients, with the national pivotal trial aiming to determine its safety and efficacy.

Statistics:

  • The HeartMate II is approximately 3 inches long and 1.75 inches in diameter.
  • The national pivotal trial will involve 200 patients at 40 sites.
  • The HeartMate II will be evaluated as a bridge-to-transplant (BTT) device for 133 patients at up to 25 sites.
  • The device was implanted in a 72-year-old Chicago man.
  • The operation lasted 4 hours.

Sources:

  • Health & Medicine Week editors
  • Staff and other reports
  • Health & Medicine Week via NewsRx.com (2005)