It was a milestone for Tucson’s SynCardia Systems when it received word the federal Centers for Medicare and Medicaid Services (CMS) will reimburse heart failure patients who have the CardioWest temporary total artificial heart device (TAH-t) implanted while they wait for a heart transplant.
The TAH-t serves as a bridge to heart transplants.
 Rodger Ford, SynCardia president and CEO, with artificial “bridge” heart. |
The reimbursement approval is a major achievement because once CMS approves a device, most other private insurers also usually agree to cover costs. Previously, about 50 percent of private insurers were covering the cost of implanting the TAH-t.
SynCardia, 1992 E. Silverlake Road, has another major landmark it hopes to reach soon — Food and Drug Aministration (FDA) approval for a portable "companion driver system" that would enable implanted heart patients to leave the hospital, go home, and live fairly normal lives while waiting for a transplant.
Up until now, the TAH-t has needed a big, 400-pound driver the company affectionately calls "Big Blue." There are just 36 of these drivers and they are used only in the handful of hospitals where the TAH-t devices have been implanted. There are 10 of those hospitals in the United States, including Tucson’s University Medical Center, plus two hospitals in France, two in Germany and one in Canada.
SynCardia, which was founded in 2001 to commercially develop the TAH-t, plans to seek FDA approval to launch a clinical study within a few months that will test its Companion I Drive System with patients in 22 U.S. hospitals. The goal is to get FDA approval of this 40-pound portable device, which will open the gates of opportunity for SynCardia. But the company is also working on a "Companion II Driver" which weighs just four pounds and can be tucked into a back pack or fanny pack. It will be released in the United States and Europe as soon as it gets regulatory approval.
Without FDA approval of its portable driver, said SynCardia President and CEO Rodger Ford, "we have been stagnated for the past three years at annual sales of $6 million." Since July 17, 2006, the 40-pound portable driver has been CE Approved - CE for the French "Conformite Europeene" certifying a product has met the health, safety and environmental requirements of the European Union. As a result, there are three times more SynCardia patients in Europe. On the other hand, patients in Europe often wait up to two years for a transplant, where in the United States a transplant could occur in as little as a few months.
FDA approval of the portable driver would:
• Enable patients to leave the hospitals where their TAH-t devices were implanted and live fairly normal lives while waiting for a heart transplant.
• Enable participating hospitals to save money because they can discharge stabilized patients and not have to retain them at their facilities until a heart transplant becomes available — months or even years later — and then be reimbursed again when the patient returns for the heart transplant.
• Enable SynCardia to choose which additional hospitals it wants as transplant partners.
• With FDA approval of its portable driver, SynCardia projects that it can double the number of patients who can have a second chance at life over the subsequent 12 months and re-double that number the following year.
The ultimate challenge is that there are only about 2,000 eligible human hearts available for transplant each year. So for eligible patients (those dying from end-stage irreversible biventricular failure), the TAH-t buys time while waiting for a transplant. Just how much time is not totally known at this point, but the TAH-t diaphragm that substitutes for natural beating heart valves has survived up to five years in SynCardia’s laboratory. And Ford said the company is continuing research to make the TAH-t progressively more resilient.
"It’s all about the denominator," Ford said, pointing out that the longer patients can survive with a TAH-t, the better chance they have of receiving a successful transplant.
And SynCardia boasts that its TAH-t has the "highest bridge-to-transplant rate" — 77 percent to 79 percent in research reported in 2004 in the New England Journal of Medicine, followed later in 2004 by FDA approval of the device. There are other devices — the left ventricular assist device (LVAD), which SynCardia says has a success rate of 57 percent to 70 percent, and the Biventricular assist device (BIVAD), which SynCardia says has a 46 percent success rate.
SynCardia said its FDA-approved 70cc TAH-t, once implanted, gives patients immediate blood flow of up to 9.5 liters per minute — about two times the normal output of a healthy human heart. This blood flow, SynCardia says, "helps rejuvenate dying organs," resulting in heart patients being "in much better condition to receive their heart transplant." The company also has 10cc, 30cc and 50cc TAH-t devices in various stages of development to cover everyone from newborns to children to juveniles and small adults.
Will SynCardia ever develop a permanent artificial heart? That’s not the company’s intent, but, Ford concedes, by default, that’s what the TAH-t sometimes essentially becomes for dying patients hoping to buy a few years while waiting for a successful heart transplant.
When Ford came on board as president and CEO four years ago, it was his goal to establish world-class business systems so the company would be ready for growth when regulatory and reimbursement hurdles allowed it. Those systems are now in place, Ford said, and the company is well prepared for future growth.
Contact reporter Ed Egger at eegger@azbiz.com or at (520) 295-4238.
Comments
Don B. Olsen wrote on May 20, 2008 2:30 PM:
The TAH was used under those restrictions in four additional patients before Dr. Copeland received FDA permission for the first bridge to cardiac transplantation in 1985. The U of Utah TAH technology was licensed to Symbion who lost FDA permission to implant the Jarvik heart in additional patients in 1990. CardioWest was started by the U of Arizona Heart Institute and the Medforte Research Foundation, in Salt lake City, Utah to preserve this technology and make it available to physicians and their very ill patients, obtaining FDA approval in 1993. It is great to see the rapid progress and successes in the clinical application of the TAH after my 36 years working in the field. "