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Medical equipment industry

First Permanent Heart Pump Implantation for Destination Therapy

Strategic Insights

— 2 min read

Advocate Christ Medical Center has announced that a 72-year-old Chicago man has become the first person to be permanently supported by the HeartMate II LVAS (Left Ventricular Assist System) for ongoing treatment of late-stage heart failure. The patient received the implantation on March 21 as part of a US phase II pivotal study by Thoratec Corporation, the manufacturer of the device. The procedure was performed by Mark Slaughter, director of the mechanical assist device program at Christ Medical Center, who stated that the patient has made significant strides and is now well enough to return home and participate in normal daily activities.

Key Takeaways:

  • The HeartMate II is a continuous flow device designed for long-term cardiac support for patients with late-stage heart failure.
  • The device is implantable, powered by a rotary pumping mechanism, and weighs approximately 12 ounces, making it significantly smaller than current FDA-approved devices.
  • The HeartMate II is designed to have a longer functional life than other approved devices and to operate more simply and quietly.
  • It is also smaller and easier to implant than pulsatile devices, providing blood flow through the circulatory system on a continuous basis with only one moving part.
  • The national pivotal trial for the device will determine its safety and efficacy as Destination Therapy in late-stage heart failure patients.
  • 200 patients will be enrolled in the trial, with up to 40 sites participating.
  • Thoratec's HeartMate XVE is the only commercially available LVAS approved for Destination Therapy by the FDA, and the HeartMate II will be evaluated alongside it in the trial.
  • The HeartMate II will also be evaluated as a bridge-to-transplant (BTT) for late-stage heart failure patients in need of temporary support until a donor heart becomes available.
  • The study will involve up to 25 sites and 133 patients in the BTT arm, with Mark Slaughter overseeing the procedure at Christ Medical Center.
  • Advocates for heart failure patients believe that this advancement will significantly improve treatment options, particularly for smaller patients who are not suited for larger pump technology.
  • The patient who received the HeartMate II implantation made great strides after the procedure and is now able to return home and participate in normal daily activities.

Statistics:

  • The HeartMate II device weighs approximately 12 ounces.
  • 200 patients will be enrolled in the national pivotal trial for Destination Therapy.
  • Up to 40 sites will participate in the trial.
  • The device will be evaluated alongside Thoratec's HeartMate XVE, which is currently the only commercially available LVAS approved for Destination Therapy.
  • Up to 25 sites will enroll patients in the BTT arm, with a total of 133 patients.
  • The patient who received the HeartMate II implantation is 72 years old.

Sources:

  • Advocate Christ Medical Center
  • Thoratec Corporation
  • Health & Medicine Week
  • NewsRx.com
  • United States Food and Drug Administration (FDA)
  • Health & Medicine Week editors

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