FDA Approves Smaller, Quieter Left Ventricular Assist Device

Shelley Wood

April 22, 2008

April 22, 2008 (Rockville, MD) - The FDA has granted marketing clearance for a new, more compact left ventricular assist device (LVAD)--one that is small enough to be used in women and in men with smaller trunk sizes. The axial-flow HeartMate II left ventricular assist system, made by Thoratec, has been slimmed down through the use of a continuous-flow pump instead of the standard pulsatile pump used in larger models. According to the company and researchers who have used the device, the more compact device will considerably broaden the pool of people who could benefit from a ventricular assist device. In addition to being compact, the next-generation device is also quieter as compared with the mechanical clicks and thuds produced by the valves and pulsatile pumps of LVADs already on the market.

In December 2007, as reported by heartwire , the FDA's Circulatory System Devices Panel unanimously recommended approval of the HeartMate II; it has been on the market in Europe for more than two years.

The HeartMate II is three inches long, weighs about one pound, and is approved as a bridge to transplantation in patients with end-stage heart failure. Support for the device comes largely from a 133-patient study published in the New England Journal of Medicine last year showing that 75% of patients implanted with the HeartMate II reached the primary end point of transplantation, "cardiac recovery," or survival at 180 days with continued transplant eligibility while on the pump [1]. Moreover, 83% of the patients who were evaluable for NYHA class at three months had improved from class 4 to class 1 or 2. In the same study, almost one-third of patients developed bleeding that required surgery over the follow-up.

As part of the approval, Thoratec is now required to conduct a postmarketing study.

Other axial-flow LVADs still under investigation include Ventracor's VentrAssist device and Jarvik Heart's Jarvik 2000.

  1. Miller LW, Pagani FD, Russell SD, et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med 2007; 357:885-896. Abstract

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The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.



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