It has been a long road to the point where SynCardia Systems is today. It's the convergence of technology and demand, along with the approval of government regulatory agencies and a set of keen business minds that has SynCardia poised to take off into the stratosphere with its CardioWest Temporary Total Artificial Heart.

But it didn't look that way five years ago. Across the country, money for medical technology development at hospitals was tight, and University Medical Center was on the brink of shutting down its artificial heart program.

To save the artificial heart and continue their innovative development work, Dr. Marvin J. Slepian, Dr. Jack Copeland, and Richard Smith started SynCardia in 2001.

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Dr. Slepian, now SynCardia's chairman of the board, said that historically, a permanent artificial heart was one of the goals put forward by President Kennedy's administration. "Two of their goals were to put a man on the moon and to develop an artificial heart," said Slepian.

"The vision in the 1960s was that the artificial heart would be a permanent implant," he said. "But the technology was actually too far ahead of the reality. There was no support structure in place, insufficient experience to deal with such a large ‘foreign material' implant, and no pharmacological support to deal with clotting and potential infection, so the technology didn't get far."

Heart transplant technology took off again in the 1980s as the necessary support structures were developed to match the technology, with the advent of anti-rejection medication and with a changing perspective on the role of the artificial heart. "There was a paradigm shift that started looking on the artificial heart as a parachute, as a bail-out device if no heart was available, and we started looking at the artificial heart as a bridge to a heart transplant instead of a permanent device.

In 1985, Dr. Copeland and a team of doctors made history at University Medical Center by successfully implanting the first artificial heart into a patient to extend his life while he waited for a transplant. That heart was the forerunner of the CardioWest heart manufactured today at SynCardia.

The need for SynCardia's artificial heart is clear. At any given time in the U.S., 100,000 patients with end-stage heart disease could benefit from a transplant. However, about only 2,500 transplants are performed each year, leaving a large number of people without treatment options.

Further, of those patients listed and waiting for transplantation, on average 15 percent die while waiting for a donor heart. For this group, the CardioWest heart is a lifesaver.

Today, SynCardia stands at the ready, with its FDA-approved artificial heart being implanted at two U.S. and five European medical centers.

But reaching this point is just the beginning for SynCardia's enthusiastic team.

Rodger Ford, chief executive officer, says that the team's next goal is to improve the portability of the artificial heart. Patients with a CardioWest heart in the U.S. must stay in the hospital because they are tethered to a driver that runs the heart. The driver consists of a large dishwasher-size console weighing about 400 pounds.

Plans to qualify lighter and smaller drivers, a tabletop model and a portable model the size of a bicycle bag, are in the works.

SynCardia is working on the two new drivers with companies in Germany that would allow for greater mobility in the hospital and the possibility that patients might be able to live at home while waiting for a transplant.

"In early 2006, we will apply to the FDA for approval of the smaller driver. We are hopeful that we'll receive approval in mid-2006," said Ford.

In preparation for anticipated manufacturing demands, SynCardia has also been shoring up its physical plant and processes. Ford said the company just finished installing a chiller to keep a consistent temperature and humidity to keep a controlled manufacturing environment, as well as an electrical generator to protect against any interruption of power.

Taking its responsibilities as an FDA-regulated company seriously, SynCardia recently completed a deal with MasterControl, a document control and complaint management system that will assist with quality control issues. The system should be up and running by September 15, said Ford.

Eventually, SynCardia hopes that its artificial heart will be a permanent option for people who are not heart transplant candidates.

Vice President of Marketing and Sales David Mackstaller said he expects that the company's growth will be beyond arithmetic and geometric. "We are launching from a higher platform," he said. "It's not a question of creating a product and then creating demand; the demand already exists. The people in the field are aware of what we're doing and the long haul is behind us."

Patients with the artificial heart will have the opportunity to lead a life without suffering, said Mackstaller. "Everyone knows someone on a downhill slide, someone who is alert and can contribute, but now they don't have to die."

Contact Martha Lundin at mlundin@azbiz.com or call (520) 295-4259.