Implantable Ventricular Assist Device

The device has been cleared by the U.S. Food and Drug Administration (FDA).

The IVAD is an implantable version of the VAD system of Thoratec (Pleasanton, CA, USA; www.thoratec.com). More than 2,700 VAD pumps are in use worldwide. The approval for IVAD was based on data from U.S. and European clinical trials involving 30 patients and cumulative support for more than 2,400 days with no device failures. One patient was supported for nearly ten months. Patients enrolled in the trial ranged from 16-71 years old.

While the VAD rests outside the patient's chest area, the IVAD's smaller size, design, and construction enable internal placement, resulting in greater comfort, mobility, and patient satisfaction. Also, IVAD allows for placement in patients who due to their small body size could not previously be treated with an implantable, pulsatile VAD. "Both devices support heart function and blood flow in late-stage heart failure patients. The IVAD uses the same internal working components of the VAD with a casing comprised of a titanium alloy.

"The clinical experience with the IVAD has been a positive one, with no serious device malfunctions or unanticipated adverse events, and patients have been pleased with how comfortable and quiet the device is,” remarked D. Keith Grossman, president and CEO of Thoratec. He also noted that the IVAD is driven by the FDA-approved TLC-II, which enables patients to be discharged to their homes.




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