PARIS — An artificial extracorporeal heart awaiting approval from the FDA was “imported” to the U.S. recently by a 13-year-old girl returning to Colorado.

The trans-Atlantic flight was a “first” for a pediatric heart patient, according to the French cardiac surgery team that transferred the patient to colleagues in Denver. The patient, identified only as Katrina of Colorado Springs was admitted to The Children’s Hospital, part of the University of Colorado Health Sciences Center in Denver.

“We’ve done this before for adults, but never for a child. It requires organizing a veritable flying hospital,” said Dr. Bernard Kreitmann, head of pediatric cardiology at H pital de la Timone Enfants (Marseille, France), during a press conference.

He said four medical personnel from France accompanied Katrina on the private jet.

The manufacturer of the artificial heart and mobile pumping unit, Berlin Heart (Berlin), also sent a technician on the flight to the U.S.

The teenager was vacationing in southern France when she experienced heart failure on July 14 while swimming. She had no previous heart history, according to her mother, and appeared to be in perfect health.

Admitted to H pital Lenval in Nice, she was transferred a few hours later to H pital de l’Archet, also in Nice, where she was sedated and put on artificial respiration.

Katrina experienced a second heart failure just as a newly formed cardiac response team from Marseille arrived, equipped with an extracorporeal membrane oxygenation (ECMO) heart-lung bypass machine that is normally used for open-heart surgery.

Her condition stabilized, Katrina was transferred to the specialized pediatric unit at the Timone children’s hospital in Marseille, where she was intubated and revived, recovering sufficiently to speak with her parents.

The cardiac surgeons informed the parents that Katrina could not be taken off the ECMO unit, which is meant only for short-term use, typically 10 days. They said that at best her heart would take months to recover, but more likely a transplant would be required.

In consultation with the family and a cardiac team in Denver, the French surgeons at Timone decided to fit Katrina with a long-term paracorporel artificial heart, the Berlin Heart Excor Pediatric unit. The surgery was performed Aug. 4.

Berlin Heart told MDD the order for an Excor left ventricular assist device (LVAD) unit was received on Aug. 3 and shipped the same day. Industry sources say the average price of an LVAD is $65,000.

Katrina’s recovery was remarkable, Kreitmann said during a press conference Aug. 17.

The patient is reading Harry Potter again, he said, and “our colleagues in Denver will be there to take her in charge, and if necessary, oversee a heart transplant operation.”

A pulsatile, pneumatically driven ventricular assist device, the Excor Pediatric heart can be used to support one or both ventricles and offers a choice of blood pumps from 10 ml to 60 ml and a range of cannulas. Cannulas are fastened to inflow and outflow sockets on the pump and then, running beneath the costal arch and through the abdominal wall, are connected to the heart and vessels.

Pumps are exterior to the body, and consist of one air chamber and one blood chamber separated by a triple membrane. The blood chamber is coated with Heparin to modify coagulation. It is common that Excor Pediatric patients receive an anticoagulation and platelet inhibition therapy.

Two different driving units are available — the stationary Ikus used during the hospital stay, and a mobile driving unit approximately the size of a baby carriage for patients fitted with 60 ml or 80 ml pumps. The mobile unit enables patients to move about with some freedom and potentially return to a home setting.

Berlin Heart received the CE mark for the mobile unit in May 2006 (MDD, May 18, 2006).

In May, Berlin Heart said the Excor Pediatric ventricular assist device had received conditional approval for Investigational Device Exemption (IDE) purposes in the U.S. Ten medical centers are scheduled to participate in the IDE study with 10 patients each.

Excor Pediatric is intended for use as a support system up to several months to bridge patients awaiting a heart transplant until a donor heart becomes available. The company said cardiac teams also have found the Excor unit effective as a bridge to recovery, allowing a patient’s heart to work on its own again.

While not yet FDA-approved, the Excor Pediatric device has been used in a total of 285 pediatric patients ranging from newborns weighing just five pounds to teenagers weighing almost 200 pounds.

The system has been used 96 times in North America, with the FDA granting permission on a compassionate-use basis.

The FDA granted use of the Berlin Heart device in March to move a 5-year-old patient in South Carolina off an ECMO unit until a donor heart became available. In April, a 9-year-old patient at the University of Florida Hospital (Gainesville) became the 68th Excor Pediatric patient in the U.S.

The bridge-to-transplant application for ventricular assist devices serves as a strategic entry point for manufacturers. The end game is to win approval for the devices as a destination therapy, or permanent use, for patients with end-stage heart failure who are ineligible for a transplant due to age, additional health problems, or other complications.

In 2001, the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure study (REMATCH) found that end-stage heart failure patients who received an LVAD device had a 52.1% chance of surviving a year, compared with a 24.7% survival rate for patients who took drugs and were medically monitored. At two years, the likelihood of survival was 22.9% for the LVAD patients vs. 8.1% for those receiving medical therapies.

The worldwide market for LVADs is estimated to be 50,000 patients. Analysts estimate the worldwide annual market for cardiac assist systems will grow to $7.5 billion by 2009 according to Berlin Heart competitor Ventracor (Sydney, Australia).

Berlin Heart was acquired last fall by Syscore, a company belonging to the family office of German billionaire Sylvia Str her (MDD, October 12, 2006).

CEO Rolf K se, MD, said at that time that having Syscore as a long-term investor would enable the company to accelerate growth, specifically in the U.S., where in 2005 the company established a subsidiary office in the Boston suburb of Northborough, Massachusetts, to serve emergency centers.