Two companies focused on the end-stage heart assist sector had good news for investors and patients over the past week.
SynCardia Systems (Tucson, Arizona) laid out optimistic prospects for the near- and longer-term at an in-vestor meeting on Friday. And early this week Packard Children's Hospital (Palo Alto, California) reported that a 6-year-old boy received a heart transplant after being supported by a ventricular assist device from Berlin Heart (Berlin, Germany) longer than any child in North America.
Rodger Ford, CEO of SynCardia, maker of the only FDA-approved total artificial heart, at the investor meeting promised that the company will move from “life-saving science venture“ to profitability this year.
SynCardia in late 2004 reached a major milestone in the artificial heart/heart assist sector with FDA approval of its CardioWest temporary Total Artificial Heart (TAH-t) for bridge-to-transplant, thus becoming the first company to win U.S. commercialization for a total artificial heart (Medical Device Daily, Oct. 19, 2004).
Ford told investors that the five-year-old company would see sales of $14.9 million and profit of about $6 million this year.
A very advanced-stage version of the original 1980s-era Jarvik heart, the TAH-t is used to keep the patient alive until a donor heart is available. About 550 patients have received CardioWest hearts or earlier versions since 1985.
Crucial to the growth promised by Ford is development of a more portable pneumatic “driver“ to power the CardioWest TAH-t devices.
Unlike the AbioCor heart from Abiomed (Danvers, Massachusetts), which is totally implanted in the patient's chest, the TAH-t is a pulsating biventricular device that replaces the patient's left and right ventricles and is sewn to the patient's remaining atria; via tubes back through the chest wall, the device is connected to a driver that provides pulsed pressurized air and enables device monitoring.
But SynCardia has been hampered by the availability of just 37 drivers inherited from Symbion, a predecessor company. These drivers, supplying power and air to the TAH-ts, are called “Big Blues“ for their filing-cabinet size and blue exterior finish.
“We can sell more hearts that we can drive,“ Ford told Medical Device Daily. But the lack of additional Big Blues has turned out to have a clear beneficial effect, forcing the company to focus on “the foundation we've laid over the last year to systematize the business,“ he said.
He said that the company is in the process of adding two smaller drivers, one from Berlin Heart – a “recovery driver, not a primary driver that the patient transfers to after two, three or four weeks on the larger driver“ – and another driver that it licensed from Medos Medizintechnik (Stolberg, Germany) that will replace a Big Blue (MDD, Sept. 9, 2004).
These alternate drivers have been submitted for CE-marking and the company plans to apply for FDA approval of the small primary driver – citing “equivalency“ to its large driver – “in April or early May,“ Ford said.
Meanwhile, while the company gears up its regulatory efforts, Ford said it is developing “clusters“ of transplant centers in the U.S. which the company will train in the use of the CardioWest TAH-t “moving from East to West Coast.“
SynCardia currently services two transplant centers in the U.S. – Tucson's University Medical Center and the Cleveland Clinic (Cleveland) – plus seven centers outside the U.S. Plans are to add two hospitals a month to the list of heart centers implanting the CardioWest hearts.
As a kind of standard, Ford noted that in 2003 a German transplant center – when fully trained on the device – implanted the CardioWest 25 times, but the number will vary based on the specific activity of the center. More generally, he said that the company is targeting up to 40% to 45% of the cases now addressed with biventricular assist devices.
“We go where bivads don't; we serve the end-stage congestive heart failure [sector] where bivads can't,“ Ford said.
As it points for the remainder of 2006 and beyond, SynCardia is “concentrating on making sure all the business systems are in place so that we'll enjoy a lot of organized success going forward, not chaos,“ Ford said. “We're concentrating on the underpinnings of the business.“
Those underpinnings are backed by $14 million “in the bank,“ he said, and the strong support of investors. “Cash flow,“ he noted, “has not been a problem for us.“
Marking an informal clinical milestone was the experience of Jason Zhao, the 6-year-old who received a donor heart at Packard Children's Hospital after being supported by the Berlin Heart for 234 days, or nearly eight months – estimated by the hospital to be the longest a child has been supported by the heart in North America.
About a month before the transplant, the boy had suffered a stroke and brain hemorrhages. Though surviving, he was paralyzed and could not talk. But after receiving a donor heart he was reported “eating, waving and saying 'hi'“ to his doctors.
Jason was placed on the Berlin Heart in June 2004 when his abnormally swollen heart suddenly stopped beating.
Rather than a temporary heart, the device is a type of ventricular assist system attached to the patient's heart percutaneously. The heart is not approved in the U.S., so the boy's doctors had to seek permission for its use from the FDA.
Only three other children in the world have survived on the pump longer than Jason, hospital officials reported.
Five other young patients at the hospital have used the device since July 2004, when a 5-month-old infant became the youngest in the country to use it.
Prior to Jason, the longest amount of time a child had lived on the pump in North America was 174 days, the hospital reported.
Last September, the Texas Children's Hospital (Houston) reported implantation of the Berlin Heart into a 3-month-old boy, considered the smallest person in the U.S. to receive the device (MDD, Sept. 30, 2005).
As in the case of Jason Zhao, emergency compassionate use of the heart was sought and approved by the FDA.