JARVIK HEART, Inc., a privately-held company that develops and manufactures cardiac assist devices, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval to the Shonin (or pre-market approval) application submitted by Century Medical, Inc., (CMI) for the Jarvik 2000 Heart, a small Left Ventricular Assist Device (LVAD) implanted inside the natural heart. CMI is the exclusive distributor of the Jarvik 2000 in Japan. Shonin approval was granted on November 22, 2013, following the 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.
The Jarvik 2000, manufactured in New York by Jarvik Heart, Inc., is the smallest LVAD approved for long-term use in Japan. At only 30cc volume and 90 grams (about the size of a C-cell battery), the Jarvik 2000 can support the hearts of patients only 4' 6" tall and weighing less than 85 lbs. Yet the same blood pump can also support large patients more than 6' 2" tall and weighing more than 225 lbs. 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 U.S., Jarvik Heart has completed a 150-patient Pivotal Trial for Bridge to Transplant. A randomized trial (with comparison to the 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 twelve 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. Today (Dec. 5th), a patient in France celebrates 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 thirteen years after implantation of her donor heart.
Jarvik Heart, Inc. is also developing a miniature Jarvik 2000 for use in infants. This work is supported by the National Heart, Lung, and Blood Institute (NHLBI) under the PumpKIN program (Pumps for Kids, Infants, and Neonates). Initiation of a multicenter clinical trial is planned for 2014.