NEWS 2004
[11/11/2004]
MicroMed DeBakey VAD, First Miniaturized Heart Pump Implanted for Long-Term CHF Therapy
HOUSTON--(BUSINESS WIRE)--Nov. 11, 2004--MicroMed Technology Inc., a world leader in miniaturized implantable ventricular assist techhnology, announced today that it has implanted the first DeBakey VADR (ventricular assist device) for Destination Therapy in the United States. This is the first use of an axial flow VAD in this application in the U.S. Destination Therapy (DT) is mechanical circulatory support for patients who are not eligible for heart transplantation. With only 2,000 donor hearts available each year for transplant, there are thousands of patients that need a reliable heart pump to stay alive.
The device was implanted at California Pacific Medical Center (CPMC) in San Francisco, by Dr. Soon J. Park, chairman of Thoracic and Cardiovascular Surgery. The implanted patient is a 78-year-old man who has had two previous heart surgeries and suffers from advanced heart failure. His condition deteriorated and his heart was no longer able to supply oxygenated blood through the body.
"The patient's condition and age made him ineligible for the heart transplant waiting list. The MicroMed DeBakey pump's size and durability made it an ideal option for this patient," said Dr. Park, adding, "The patient continues to improve from the implant surgery, and we look forward to an uneventful recovery so he can return home to his family and friends. I'm very happy to be able to offer this patient this new and exciting technology. California Pacific is very fortunate to be the first hospital in the United States to offer this next generation mechanical support device for the treatment of heart failure."
Dr. Michael DeBakey commented on this progress, "We are very encouraged with Dr. Park's initial step in providing relief in a new generation of mechanical support for patients with chronic heart failure."
The miniaturized DeBakey VAD represents today's newest generation of implantable mechanical ventricular support for advanced heart failure. Its design addresses significant limitations of first generation systems such as weight, size, noise, reliability and high rates of infection. It is intended to be highly durable and is the size of a "C" cell battery, measuring only 1"x 3" at 4 ounces.
"We are proud to have achieved this critical milestone. The DELTA? trial (Destination Evaluation of Long Term Assist), is a landmark study for advanced heart failure patients in collaboration with leading physicians and transplant institutions across the country," said Dallas Anderson, president and CEO of MicroMed. "Our experience with 280 Bridge to Transplant patients worldwide gives us a strong foundation to initiate this application. The number of patients waiting for a reliable mechanical support device to take the place of a heart transplant is in the thousands."
The DELTA trial format consists of 360 adult patients in a 2:1 ratio of DeBakey VADs in a randomized trial using the HeartMate XVEョ of Thoratec Inc. as control. Once recovered from the surgery, patients are allowed to return to their usual lifestyle with their family and friends while they are followed for up to two years. The device is eligible for hospital reimbursement, CMS DRG 103 coverage is in the $136,000 per procedure range
About California Pacific Medical Center
California Pacific Medical Center, a Sutter Health affiliate, is one of the largest private, not-for-profit teaching medical centers in Northern California. We are a tertiary referral center providing access to leading-edge medicine while delivering the best possible personalized care. California Pacific provides a wide variety of services, including acute, post-acute and outpatient hospital care; home care and hospice services; preventive and complementary care, and health education. Through our Medical Education Program and our Research Institute, physicians at California Pacific Medical Center are able to bring health care innovation to the bedside.
About MicroMed
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 is approved for implantation in non-heart transplant candidates in up to 40 hospitals across the country.
The DeBakey VAD is approved for use in its pivotal clinical trials under an FDA Investigational Device Exemption for both Destination Therapy and Bridge to Transplantation. The DeBakey VAD system has been awarded the CE mark for commercial distribution in Europe, with over 280 VADs implanted worldwide. The DeBakey VAD Child, already commercially released through an HDE, utilizes the same technology for support of pediatric patients.
MicroMed Technology Inc. is a privately held company that develops products for patients with end-stage, congestive heart failure (CHF). MicroMed's headquarters and ISO 9001 certified Class 10,000 clean room manufacturing facility is located in Houston, Texas. For more information, visit www.micromedtech.com.
The MicroMed DeBakey VADR is an investigational device and is limited by federal law for investigational use in the United States.
Contacts
Pierpont Communications, Houston
Sally Ramsay
sramsay@piercom.com
713-627-2223, ext. 102
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