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December 20, 2001

Replacement Heart Sets Milestone for Medical Device Industry

By Katrina C. Arabe

Medical technology witnessed very significant advances in 2001. The creation of a fully self-contained mechanical heart lead the pack of awe-inspiring developments.

This month, IndustryWeek magazine awarded the Abiocor Implantable Replacement Heart first place on its list of the top technological innovations of 2001. What makes this device different from other mechanical heart ventures in the past is that, unlike its predecessors, the Abiocor functions without the user being permanently attached to a power source. Instead it runs on batteries that are worn on the user's belt. In addition, the Abiocor is cheaper to produce than earlier mechanical hearts and its upcoming model is expected to run smoothly for five years, a period of use that is deemed "productive" in comparison to the cost and stress of the surgical implant. (The Abiocor being currently tested is expected to function trouble-free for 16 months.)

The design of the Abiocor is a portrait of ingenuity. It has a centrifugal-force motor at its center surrounded by a siliconized fluid. This fluid is enclosed in Angioflex, a plastic developed exclusively by Abiomed to achieve an exceptional smoothness essential to damage-free blood cells. Two chambers recreate the heart's ventricles and the motor shunts the siliconized fluid back and forth between them, causing the volume of the ventricles to expand or contract, moving blood in and out of the device and achieving circulation. The outer layer of the device is fashioned from titanium. A waterproof coil transfers power from Abiocor's batteries to an insertion in the ribcage near the device. These batteries last four hours per charge. The coil can be connected to a permanent power source while the user is sleeping or involved in some other long-term stationary activity. Areas of future development of the Abiocor include extending battery life and engineering different sizes to fit a wider variety of users.

Laman Gray, the cardiothoracic surgeon who implanted the replacement heart in the first trial patients, is predicting a new era in medicine - a "continuum of care," as he puts it - that utilizes mechanical devices to assist the body's circulatory system. Until that day comes, he concedes, transplants have a high success rate of doing the same. As for the immediate future, if the Abiocor's technical refinements continue without a hitch and if the Food & Drug Administration (FDA) gives the device its full approval, then the replacement heart could be on the market by as early as 2003. Then the groundbreaking Abiocor can begin to benefit those who it was made for - the estimated 100,000 people in the U.S. who are suffering from heart failure. In Gray's words, "We've demonstrated that we can implant an artificial heart and have a good quality of life."

Source: Technologies of the Year – AbioCor Implantable Replacement Heart
Tonya Vinas
Industryweek, Dec. 1, 2001
http://www.industryweek.com/CurrentArticles/asp/articles.asp?ArticleID=1162

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