Today's hi-tech medical world has an array of support technologies sometimes referred to as "bridge" technologies. These solutions are not meant to be permanent; they're designed to address an urgent medical need and keep patients alive until, hopefully, a more definitive solution can be delivered.

One example is dialysis. Patients with kidney failure are able to use dialysis machines to stay alive until another, more permanent medical solution can be found. For some types of heart failure, a Ventricular Assist Device, or VAD, can be an appropriate bridging technology. Unfortunately, VAD's are a high-cost, high-risk solution. The Pittsford-based biotech company Myotech and its distribution partner Biophan are well down the road to offering a simpler, cheaper, less intrusive solution.

Current VAD technology requires that tubes physically pierce into the heart itself. The tubes need to do this because the VAD passively drains the blood that tends to fill up a weakened, damaged heart. The VAD's tubes connect to an electromechanical device that helps the heart drain. Because the tubes pierce the heart tissue and come into direct contact with blood, VAD patients often experience complications such as clotting and stroke, bleeding, and infection. An MD friend of mine has called VADs "medieval torture devices." Jeffery L. Helfer, president of Myotech and of Biophan Technologies' cardiovascular division, is more charitable. "Current VAD technology originally showed great promise 20 years ago," he says, "but has not been able to deliver on that promise."

The approach of Myotech's MYO-VAD is to provide support for the heart and help it do the full cycle of pumping that it's supposed to do. Where current VAD's work passively, on a single ventricle, the MYO-VAD actively works with the whole heart. The core of the MYO-VAD is a polymer cup similar in shape to a wine glass or an eggcup. Air pressure is raised and lowered to allow the inside of the cup to move. This in turn gently expands and contracts on the heart, allowing it to pump more efficiently. To visualize the effect, imagine holding a water balloon in your hand and gently squeezing it. Since the heart isn't punctured, most general or emergency-room surgeons can install and remove it in just a few minutes.

Myotech currently has five employees, focused mainly on bringing the MYO-VAD through the FDA processes and clinical trials to get approval for regular clinical use in humans. Both Helfer and John Lanzaflame, CEO of Biophan, anticipate that once that's achieved, Myotech will bring on a much larger medical and clinical workforce to continue to develop the MYO-VAD technology for a variety of clinical applications.

In Helfer's last six years working with the technology, he's seen new opportunities for the application of the medical technology "Current VAD technology performs best for adults around 5' 11" tall weighing about 180 pounds," Helfer says, "due to the size and requirements of the technology." That means most women are too small for them. Because the MYO-VAD's main component is a rubber-like cup, it can be molded into a variety of sizes. And since it can be installed quickly and easily by doctors with emergency medical training, the MYO-VAD is of interest to the military. It could be used in field medical units, for example, to stabilize wounded soldiers during transport to a hospital. Myotech is one of the recipients of a $1 million federal grant for high-tech medical research in Rochester. MYO-VAD technology is also a good candidate for use outside of the US, since its costs are dramatically lower than current VAD technology.

The company has seen the technology through a range of animal tests with great success. The FDA hasn't yet approved the technology for trials in humans. (Generally, years of animal trials are required before limited human trials are allowed.) But the MYO-VAD has been used five times in emergencies where lives were threatened and nothing else would allow the person to live long enough to benefit from more traditional treatment. In each of those cases, the MYO-VAD worked flawlessly in FDA emergency exceptions cases. Formal human trials are expected to begin in the next 18 months, and the product could be approved by the FDA for use in 2009.