Medical Device Daily Washington Editor

The market for devices that address various diseases of the heart may seem saturated, especially where the various forms of cardiac assist devices are concerned, but the American economic engine seems inclined to take technological change for granted. And while the premarket approval database at the FDA is chock full of listings of industry stalwarts such as Medtronic (Minneapolis), St. Jude Medical (St. Paul, Minnesota) and Abbott Laboratories (Abbott Park, Illinois), smaller companies are generating new technologies and new approaches to the medical problems that have assailed our species since before recorded history.

However, the most effective fix for a problem does not always employ cutting-edge technology, and the companies involved in the manufacture and development of the MYO-VAD are hoping that this proves to be the case for cardiac assist devices.

The MYO-VAD is an invention of Myotech , which inked a deal with Biophan (both West Henrietta, New York) last September to take over the marketing, development and regulatory approval of the MYO-VAD (Medical Device Daily, Sept. 15, 2005). This device is designed to give the patient a more complete range of cardiac function while avoiding the direct contact with blood that is thought to underlie much of the difficulty encountered with other ventricular-assist devices (VADs).

According to Jeff Helfer, vice president of engineering at Biophan and president of Biophan Cardiovascular, the MYO-VAD is built on a polymer made of “a silicone material of proprietary origin.“ The device consists of a cup attached to a lead that allows pressurization of the cup by a pump outside the body, which all current iterations of the device have. The cup weighs about two ounces and is about a quarter of an inch thick, including “a semi-rigid outer liner.“

Unlike conventional VADs, this device assists in both diastolic and systolic functions. This is possible because the device uses pressure from a gas to both contract and expand the cup, thus providing the dual action needed to generate the optimal effect. Biophan CEO Michael Weiner stated that the design of the device will avoid the “significant bruising“ of the heart that can be induced by other means.

The company said that another advantage of the design of the MYO-VAD is that it makes use of a natural feature of the human heart. Helfer said that thanks to a difference in the inherent thickness of the ventricular walls, the cup “pumps the right ventricle first and then the left,“ which mimics more closely the natural function of the heart.

Future iterations designed for complete internal implantation could then operate on hydraulic pressure, but the current models will rely on pneumatic pressure for now. Weiner stated: “We could have a fully implantable device in time, that's our intention.“

The tube connecting the cup to the pump is less than half an inch in diameter and can carry more than pressure to the cup. At present, the firms are working on a drug delivery system that would bathe the heart in therapeutic drugs, possibly even regenerative biologics.

The device has undergone extensive testing, including 700 animal tests, and the results seem to encourage the companies. Weiner stated that “animal studies show that it increases perfusion, which may be a godsend to the post MI [myocardial infarction] patient.“ Nonetheless, the device is still in preclinical studies. One of the areas that Myotech and Biophan are working on is development of a “drive unit that is state-of-the-art.“ This is desirable not only from a therapeutic standpoint, but also assists in the marketing of the device inasmuch as the firms are looking for “a partner that could put their label on“ the MYO-VAD.

As noted before, the technology behind the device is not quite the latest thing, but is not the age of the wheel, either. Weiner commented that “the idea has existed since the late 1980s, and reasonably competent technology has existed since the 1990s.“ One of the impediments in getting this kind of technology to market is that “some of the ideas in medical technology are hard to finance.“

However, Weiner was not easily sold on Myotech's offering. “I did not invest in Myotech until I had pre-validated“ the ideas with others in industry, he remarked.

As anyone in the medical device industry knows, marketing a new product can be as burdensome as manufacturing and testing. Weiner said that Biophan will seek out a larger company to take on the marketing, including “the biggest three in the business.“ The inattention of the big players to date has allowed these small firms to avail themselves of “one of the biggest opportunities“ in the industry, which eliminates the need to set up a sales force, he said. Biophan intends to write a marketing agreement “within 12 to 24 months,“ Weiner said.

Weiner noted that he was open to a company with a “really good sales force and a global reach.“ However, he said that the partners also felt that it is important to do business with a firm that has garnered substantial “credibility with physicians“ to speed acceptance.

Much of the optimism is based on the therapeutic effect, but ease of installation may also play a role. In times to come, Biophan hopes that the device will be implanted via two relatively small incisions. Weiner observed that “eventually, a general surgeon might be able to install the MYO-VAD,“ but for now, it will probably be solely the province of cardiac surgeons. He made the case that surgeons sometimes are wary of VADs because of the history of problems associated with existing models, but was optimistic that “if they see a device that eliminates these problems,“ they will be inclined to make use of it.

The size of the market for VADs is enormous, and Biophan expects the MYO-VAD to avail itself of a sizeable chunk. According to ABN-AMRO Morgans (Brisbane, Australia), sales of VADs in 2003 rang in at $400 million and may balloon to $7.1 billion by 2009.

However, Weiner insisted that the VAD market may be underestimated because current technology is more therapeutically limited than the MYO-VAD. The device may also drive expansion of the market because of cost. He stated that at present, the typical VAD installation costs a healthcare system more than $200,000, but reimbursement may run only to $10,000. He estimated that the cost per installation of MYO-VAD will be only on the order of $60,000, which will encourage administrators to examine it more closely.

Among the proposed uses of the MYO-VAD are as a device for resuscitation in acute-care and emergency settings, but it might also find use as a bridge-to-bridge device while the patient seeks more permanent therapeutic options. It could also bridge the patient to a transplant, but may also find some use as a “destination“ device.

“We don't see a limitation on long-term use like those for other VADs because of lack of damage to blood tissues,“ Weiner said.

Helfer added that talks with Du Pont (Wilmington, Delaware) engineers whose materials are use in the system have lead the company to “expect the device to last the life of the patient.“ The expected life of the cup, he said, may be as long as 20 years, which will usually exceed the life of the patients.

As for applications to the Centers for Medicare and Medicaid Services(CMS), Biophan said it would like to apply for use as a bridge-to-bridge and bridge-to-recovery item because these are easier uses to clear, but the hope is that Biophan could persuade CMS to issue a national coverage decision for a much wider range of applications.