Physicians struggling to save the lives of people suffering sudden cardiac arrest (SCA) will, many times, administer defibrillation, cardiopulmonary resuscitation, drug therapy or they will crack open their chests and massage the heart. But these efforts often are fruitless, with at least an 80% mortality rate.

Biophan Technologies (Pittsford, New York) has taken a cue from the latter technique with the development of Myotech CSS, a flexible plastic sheath that slips around the heart and literally pumps it back to life.

The Myotech CSS is based on direct mechanical ventricular actuation (DMVA) technology. It consists of a flexible polymer cup that can be installed around the heart in as little as three minutes via thoracotomy, an incision between ribs.

"It is a mechanical circulatory support device, but it's totally different in design," John Lanzafame, Biophan's CEO, told Medical Device Daily. "Ventricular-assist devices [VAD] are typically blood pumps. They actually pump blood, bypassing the heart chamber. Ours is a heart pump. It's a device alternative to doing cardiac massage, but it's much more controlled, it applies uniform pressure, and it can run for days."

Lanzafame explained that it can be used as a bridge to CABG, bypass surgery, heart transplant or even recovery because it can both resuscitate a stopped heart and provide cardiac support while waiting for additional therapy or transplant.

Incorporating a pneumatically activated liner, the Myotech CSS operates by compressing and expanding bi-directionally, providing the energy that allows the heart to restore blood flow to normal, life-sustaining levels. Because there is no contact with circulating blood, it is expected to significantly reduce the risk of patient complications, such as clotting and stroke, bleeding and infection.

"Given the unique features of Myotech CSS compared to what's on the market, we think it will position us to address an unmet market niche," Lanzafame said.

In the U.S., there are 263,000 in-hospital sudden cardiac arrests every year. There are 70,000 cases per year of heart stoppage due to myocardial infarction with cardiogenic shock with a 70% mortality rate. He said Myotech CSS will address that secondary market as well.

Biophan's board of directors has just approved the next phase of Myotech's (also Pittsford) engineering and regulatory development program for the Myotech CSS with the release of $2 million to be invested in its development. Myotech is a majority-owned subsidiary of Biophan.

Lanzafame said the company is searching for partners to commercialize and distribute Myotech CSS and will later seek approval overseas.

Clinical data is as yet unavailable, but a previous version of the technology, originally developed at Duke University (Durham, North Carolina) has been tested in more than 700 animals and the company has anecdotal evidence that it has helped to save human lives.

The company has yet to announce its development and regulatory plan, but, "With our current strategy, the Myotech CSS could be on the market in the U.S. in 24 to 30 months," Lanzafame said. "We are in early-stage discussions with a number of distribution and commercialization partners."

The company has enough funding to move through the next stages of development but will seek additional funding, "potentially through distribution/commercialization relationships," he said.

It's a little early, too, for targeting a cost of the device, but Lanzafame said it can easily be priced competitively with existing VADs. While the sheath part that fits over the heart will be considered disposable, the external console that runs the pump is reusable.