Mitsui Ventures 三井ベンチャーズ(MVC、MCVP) ベンチャーキャピタル ベンチャー 三井物産 起業

NEWS 2004

[03/03/2004]

The First Miniaturized Heart Pump for Children Approved

HOUSTON -- March 3, 2004 - MicroMed Technology, Inc., a global leader in miniaturized heart pump technology, announced today that it has received Food & Drug Administration (FDA) Humanitarian Device Exemption (HDE) approval to provide transplant centers with the DeBakey VAD Child heart pump, designed to improve blood flow for children aged 5 to 16 who are awaiting a heart transplant.

"After so many years of development in the VAD industry, we are very proud and excited that we will be able to help support children who have devastating heart diseases," said Betty Silverstein Russell, MicroMed executive vice president. The DeBakey VAD Child utilizes the technology of the implanted adult pump and further miniaturizes it for use in children. This is the first VAD approved by the FDA for use in children. Until now, the usual method of circulatory support in children was a heart-lung bypass setup in the intensive care unit. The new VAD will not replace the bypass needed for primary lung failure.

"This represents our intent to continue to add value to the mechanical heart support sector," said Dallas Anderson, MicroMed president and CEO. "MicroMed has FDA approval in the U.S. for two multi-center adult pivotal trials for ventricular assist use, as a Bridge-to-Transplant and for Destination Therapy. The new pediatric centers contribute an important area of experience not previously addressed in VAD development. For the first time, recovering children will be able to move from the intensive care unit to a more comfortable setting."

Designed in collaboration with NASA, the Baylor College of Medicine and Drs. Michael DeBakey and George Noon, the DeBakey VAD is intended for end-stage heart failure patients who can no longer provide necessary blood flow with their native heart. The DeBakey VAD system has been awarded the CE mark for commercial distribution in Europe, with over 240 VADs implanted worldwide. The implanted device is the size of a "C" cell battery, is silent, and weighs less than four ounces.

About MicroMed

MicroMed Technology Inc. is a privately held company that develops products for patients with end-stage congestive heart failure. The MicroMed DeBakey VADｮ was developed through collaboration with Dr. Michael DeBakey and Dr. George Noon of Baylor College of Medicine. NASA developed the mechanical and fluid dynamics capabilities in conjunction with the doctors? clinical expertise. The heart pump is only 1"x 3", weighs only 4 ounces and is silent in operation. MicroMed's manufacturing facility is ISO 9001-certified and recently passed a Food and Drug Administration GMP inspection.