Jarvik Heart, a manufacturer of cardiac assist devices, has announced the Shonin approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the Jarvik 2000 heart, a small left ventricular assist device implanted inside the natural heart.
Century Medical, the exclusive distributor of the Jarvik 2000 heart in Japan, had previously submitted the Shonin (or pre-market approval) application with the PMDA.
The PMDA has granted the Shonin approval on 22 November 2013 following its review of data on Japanese and US clinical trials with the device.
Jarvik 2000 weighs 90g at 30cc volume. Jarvik Heart claims that Jarvik 2000 is the smallest left ventricular assist device approved for long-term use in Japan.
Jarvik 2000 can support the hearts of patients weighing less than 85lbs and 4′ 6" tall. The same blood pump can also support large patients weighing more than 225lbs and more than 6′ 2" tall.
The blood pump will be operated at slower speeds for smaller patients, while at higher speeds for larger patients.
Jarvik Heart has obtained CE Mark approval for Jarvik 2000 in Europe and the company has completed a 150-patient pivotal trial in the US for bridge to transplant.
A randomized trial (with comparison to the HeartMate II) for long-term use is currently in progress. In this trial, more than 300 patients will be evaluated for survival two years after implant and for absence of infection at three years.
Jarvik Heart is also developing a miniature Jarvik 2000 for use in infants.