Healthcare Industry News: circulatory support
News Release - December 4, 2006
MicroMed Receives Approval for 5-Year CE Mark Extension of DeBakey Ventricular Assist Device and Announces 400th Implant of DeBakey VAD(R) System at Methodist Hospital, Houston, TexasHOUSTON, TX--(Healthcare Sales & Marketing Network)--Dec 4, 2006 -- MicroMed Cardiovascular, Inc. (OTC BB:MMCV.OB ) received from its Notified Body, TUV, an approval extending the DeBakey VADŽ system's CE Mark for an additional 5 years. The new European Union CE Mark is valid until April 27, 2011.
The formal extension of the CE Mark's approval by the TUV is based upon a complete and rigorous scientific review of the DeBakey VADŽ system and accessories from both a design/manufacturing/quality perspective as well as a comprehensive review of all of the commercially implanted patient experience gained since the original CE Mark certification on April 27, 2001 for its approved Indications For Use.
The renewal of the CE Mark assures that MicroMed will continue to meet its obligation to provide safe and effective uninterrupted access to commercially approved medical devices. These devices support patients, their families and physicians who are in need of the DeBakey VADŽ system's delivered therapy to support their bridge-to-transplant, destination therapy and child or pediatric indications for patients with end stage heart failure.
Currently, 400 DeBakey VADŽ Systems have been implanted worldwide. The 400th implant was performed on October 20, 2006 by Dr. Matthias Loebe of Methodist Hospital in Houston, Texas. "We are pleased to announce that we have implanted the 400th patient at Methodist Hospital here in Houston, Texas. This is also where the first US implantation of the DeBakey VADŽ occurred," said Dr. George Noon, Professor and Chief, Division of Transplant and Assist Devices in the Michael E. DeBakey Department of Surgery.
About our Technology
MicroMed's initial platform in heart failure products is the DeBakey VADŽ (Ventricular Assist Device) in clinical study for the treatment of advanced heart failure. "This represents our objective to continue to improve quality of life for patients with complex heart failure," said Mr. Robert Benkowski, Chief Operations Officer of MicroMed Cardiovascular, Inc. There are currently 15 million victims of heart failure worldwide. With approximately 2,000 donor hearts suitable for transplantation becoming available each year in the United States or 4,000 worldwide, MicroMed believes that the DeBakey VADŽ represents an important therapeutic option for this population. The DeBakey VADŽ represents a new generation of miniaturized implantable mechanical circulatory support devices. Designed in collaboration with NASA, the Baylor College of Medicine and Drs. Michael DeBakey and George Noon, the DeBakey VADŽ is intended for adult and pediatric advanced heart failure patients who can no longer provide necessary blood flow with their native heart. The proprietary technology is designed to take over virtually all left ventricular function and concurrently monitor real-time flow parameters. "MicroMed's DeBakey VADŽ provides additional options in heart failure products for both adults and smaller patients with the added benefit of being small in size, virtually silent and will eventually add significant quality of life," said Robert Benkowski.
About MicroMed Cardiovascular, Inc.
MicroMed currently has an ongoing clinical investigation in leading US heart transplant centers to evaluate the safety and effectiveness of the DeBakey VADŽ for use as a Bridge to Heart Transplantation. The DeBakey VADŽ system has been awarded the CE Mark for Bridge to Transplant and Destination Therapy for commercial distribution in Europe. The DeBakey VADŽ Child, the only approved miniaturized implantable VAD in the US, is available for use in children. It has also been awarded the CE Mark for commercial distribution in Europe. A total of 400 adult and pediatric devices have been implanted worldwide for 110 patient years of experience. MicroMed's manufacturing facility, located in Houston, Texas, is ISO 13485:2003 certified.
For more information, visit www.micromedcv.com.
This news release contains certain forward-looking statements pertaining to future anticipated projected plans, performance and developments, as well as other statements relating to future operations and results. Any statements in this news release that are not statements of historical fact may be considered to be forward-looking statements. Written words such as "may," "will," "expect," "believe," "anticipate," "estimate," "intends," "goal," "objective," "seek," "attempt," or variations of these or similar words, identify forward-looking statements. These statements by their nature are estimates of future results only and involve substantial risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors including, but not limited to, risks related to: our ability to obtain additional funding to support our business activities; the early-stage market for ventricular assist products and services; an expected dramatic rise in expenses; rapid growth and change in our business; as well as those risks more fully discussed in the Company's reports filed from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing its views as of any subsequent date. We do not undertake any obligation to update any forward-looking statements to reflect events or circumstances after the date of this release.
The MicroMed DeBakey VADŽ is an investigational device and is limited by federal law for investigational use in the United States.
Source: MicroMed Cardiovascular
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