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.