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Long-Term Experience With the DuraHeart(TM) Left-Ventricular Assist System Continues to Grow

Press releases may be edited for formatting or style | August 12, 2010

The DuraHeart LVAS can be used as a bridge to heart transplant in patients with end stage heart failure. Due to the scarcity of donor organs, patients can sometimes be on the waiting list for many months until a suitable donor becomes available. During that time, a patient's condition can deteriorate dramatically until no other alternative is available to them. The left ventricular assist systems offer the patient a second chance while waiting for a suitable donor

"Mrs. Gieseke is yet another excellent example of the important work that leading Physicians around the world can accomplish in treating end stage heart failure, supported by the people at Terumo Heart," said William Pinon, President and CEO, Terumo Heart. "It is truly gratifying to see the impact of our DuraHeart LVAS in bringing long-term quality of life back to patients who otherwise would have few options for treatment in the absence of a heart transplant."

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The DuraHeart LVAS is the latest-generation rotary blood pump designed for long-term patient support. The system incorporates a centrifugal flow rotary pump with the magnetically levitated impeller. The pump features three position sensors and electromagnetic coils that suspend the impeller inside the pump chamber without a single contact point. The impeller's active magnetic levitation is designed to eliminate friction by allowing a wide gap between blood contacting surfaces, enabling blood to flow through the pump unimpeded in a smooth, non-turbulent fashion.

The DuraHeart LVAS is currently being studied in the DuraHeart Pivotal U.S. Trial for Bridge-to-Transplant (BTT), a multi-center, prospective, non-randomized study, involving 140 patients. The study, which was granted unconditional approval in early 2010 by the U.S. Food & Drug Administration (FDA), will evaluate the safety and efficacy of the device in helping to sustain patients awaiting heart transplant who are at risk of death due to end-stage heart failure. The DuraHeart LVAS carries a CE Mark and is currently available for sale in European countries. The company has completed clinical trial enrollment for this device in Japan. Additionally, Terumo Heart has submitted its Destination Therapy Investigational Device Exemption to the FDA, which is a first step in the process of obtaining approval to begin its DuraHeart DT Clinical Trial in the U. S.

For more detailed information about the DuraHeart BTT Trial, visit http://www.clinicaltrials.gov, and for more information about the DuraHeart LVAS, visit http://www.terumoheart.com.