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Back To Vidyya FDA Approves Expansion Of The Micromed Debakey VAD® Clinical Trial

Six Patients Have Been Implanted With The Device Thus Far

MicroMed Technology, Inc. today announced that it received approval from the Food and Drug Administration (FDA) to expand the US MicroMed DeBakey Ventricular Assist Device (VAD) feasibility study from its initial site at The Methodist Hospital in Houston, Texas to three sites and 20 patients.

At Methodist Hospital, six patients have been implanted with the device by lead investigator Dr. George Noon, cardiovascular surgeon and Baylor Professor of Surgery, with assistance from co-investigator Dr. Michael DeBakey, Baylor College of Medicine Chancellor Emeritus.

Following internal approvals, the additional sites are expected to begin implantation of the MicroMed DeBakey VAD® in early 2001. It is expected that this expanded feasibility study will provide MicroMed with enough information to begin an FDA-approved multi-center pivotal study, eventually leading to FDA approval to market the device.

The MicroMed DeBakey VAD®, developed with the support of Dr. DeBakey, Dr. Noon and engineers at NASA, has been implanted in 72 patients worldwide, six in the US and 66 in European clinical trials.

"We are committed to bringing the miniaturized MicroMed DeBakey VAD® to market along with the unique benefits it can provide for the thousands who suffer from end-stage heart failure," said MicroMed President and CEO Dallas Anderson. "The MicroMed DeBakey VAD® has demonstrated favorable outcomes thus far, and we expect this additional trial to support this trend."

Measuring 1" x 3" and weighing less than four ounces, the MicroMed DeBakey VAD® is a miniaturized axial flow heart-assist pump. Due to its small size, the implantation surgery is less invasive than with larger LVADs, reducing operating time, tissue disruption, risk of infection and perioperative bleeding. Capable of pumping in excess of 10 liters of blood per minute, the heart assist device provides rest to the heart muscle by taking over the pumping action for the diseased heart.

Congestive heart failure (CHF) afflicts 15 million people worldwide and five million people in the US Heart transplants are traditionally the only available treatment for end-stage CHF patients; however, due to lack of donor hearts, approximately 2,500 heart transplants are performed each year. Patients waiting for a heart transplant have the option to be implanted with a VAD to keep them alive until a donor heart can be found. VADs are currently marketed only as a bridge to heart transplant, but MicroMed believes VADs have the potential to be used as an alternative to heart transplant in the future. This new indication would increase the VAD market potential dramatically, from approximately $120 million for bridge to transplant, to a projected range of $2-4 billion annually, when used as an alternative to heart transplant.

The MicroMed DeBakey VAD® is an investigational device and is limited by federal law to investigational use.

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Editor: Susan K. Boyer, RN
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