Newly-Private MicroMed: Is it Destined for Greater Markets?
Article preview reprinted from Start-Up - February, 2009
MicroMed has the smallest LVAD on the market (outside of the US), which makes it suitable for the sought-after destination therapy market. The MicroMed LVAD has been implanted in more then 450 patients, which makes it second only to Thoratec in terms of the number of implants. But it hasn't been easy.
Newly-Private MicroMed: Is it Destined for Greater Markets?
Article preview reprinted from Start-Up - February, 2009
When we first became acquainted with Houston's MicroMed Cardiovascular Inc. (then known as MicroMed Technology) in 1998, the start-up sought to bring left ventricular assist devices (LVADs) into the Space Age, which was only natural since it licensed its core technology from NASA. Famed heart surgeons Michael DeBakey and George Noon provided the clinical expertise in the development of the device. (See "The Bridge Across Forever: Devices for CHF" START-UP, October 1998.)
Back in 1998, ventricular assist devices were in their first decade of use as circulatory support systems to bridge patients over to heart transplantations, an indication that arose because there aren't enough donor hearts for the patients who need them. Out of five million patients with heart failure in the US, 100,000 are in the end stages of the disease, and many would die while waiting for a heart without additional circulatory support. Some patients wait a long time for a new heart, since there are only approximately 2,000 donor hearts available in the US each year (approximately 4,000 worldwide).
The first-generation devices on the market, the biventricular, paracorporeal VAD of Thoratec Corp., the HeartMate from Thermo Cardiosystems (now owned by Thoratec) and Baxter International Inc.'s Novacor LVAS (since acquired by World Heart Corp. from Edwards Lifesciences Corp.), were large and heavy pulsatile pumps, too bulky for many patients, and with many moving parts that limited their durability. MicroMed wanted to proffer a next-generation device, small, completely implantable in patients of all sizes, and capable of long-term cardiac support for efficacy in both the short-term bridge-to-transplant market, a niche market, and the much larger, longer-term destination therapy market, which encompasses as many as 60,000 to 100,000 patients a year that require long-term or even permanent support.
Fast forwarding to 2009, MicroMed is now the most advanced player in the fourth generation of ventricular assist devices, that is, small implants that can be placed in the pericardial space, in contrast to previous generation, larger, heavier devices that are implanted in the abdominal area. (See Exhibit 5.) In fact, MicroMed has the smallest LVAD on the market (outside of the US); it weighs 92 grams, and its closest competition, which just gained CE mark in January 2009, the HVAD of HeartWare International Inc., weighs 145 grams. Out of more than a dozen LVAD developers, these two companies are the only ones with approved devices for implantation in the pericardial space. This is an advantage, says MicroMed director Rodger Ford, because it offers a short blood path. For the majority of devices implanted in the diaphragm, "all of that extra plumbing can cause complications—infections and thrombus," he says.
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Companies mentioned in this article:
Baxter International Inc.
Edwards Lifesciences Corp.
HeartWare International Inc.
MicroMed Cardiovascular Inc.
National Institutes of Health
St. Luke's Health System
Texas Heart Institute
Thoratec Corp.
Ventracor Ltd.
World Heart Corp.
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