Japanese Authorities Approve Jarvik 2000 Heart

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval to the Jarvik 200 heart, manufactured by New York, N.Y.-based Jarvik Heart Inc. The device is a small left ventricular assist device (LVAD) implanted inside the natural heart. The application was submitted by Century Medical Inc., the exclusive distributor of the Jarvik 2000 in Japan.

The approval followed PMDA’s review of data on Japanese and U.S. clinical trials with the device. In Japan, where there is an extended waiting time for donors, patients have been supported long term by the Jarvik 2000, for up to four years, and then have been successfully transplanted once a donor heart has become available, according to the company.

The company claims that the Jarvik 2000 is the smallest LVAD approved for long-term use in Japan. At only 30 cc volume and 90 grams (about the size of a C-cell battery), the Jarvik 2000 can support the hearts of patients only 4 feet, 6 inches tall and weighing less than 85 pounds. Yet the same blood pump can also support large patients more than 6 feet, 2 inches tall and weighing more than 225 pounds. For smaller patients, the pump is operated at slower speeds; for larger patients, it is operated at higher speeds.

In Europe, the Jarvik 2000 Heart has CE mark approval. In the United States, Jarvik Heart has completed a 150-patient pivotal trial for bridge to transplant. A randomized trial (with comparison to Thoratec Corp.’s HeartMate II) for long-term use is currently in progress. More than 300 patients will be evaluated for survival two years after implant and for absence of infection at three years. 

More than 600 patients at dozens of hospitals in 12 countries have been treated for severe heart failure with the Jarvik 2000. Many patients have been transplanted or supported long-term with an excellent quality of life, according to the company. A patient in France recently celebrated his eighth year of active life supported by the Jarvik 2000. The very first patient to receive the Jarvik 2000 as a bridge to a transplant is doing well 13 years after implantation of her donor heart, officials report.

Jarvik Heart also is developing a miniature Jarvik 2000 for use in infants. This work is supported by the National Heart, Lung and Blood Institute under the PumpKIN program (Pumps for Kids, Infants and Neonates). Initiation of a multicenter clinical trial is planned for 2014.