Jarvik Heart said it won pre-market approval from the Japanese Pharmaceuticals & Medical Devices Agency for its Jarvik 2000 heart, a left ventricular-assist device.
New York-based Jarvik Heart said the device is the smallest LVAD approved for long-term use in Japan.
The Jarvik 2000 is capable of supporting patients as small as 4′ 6″ tall & weighing less than 85 lbs. and as big as 6′ 2″ tall & weighing more than 225 lbs., by utilizing different speeds for the different sizes.
The device already has CE Mark approval in the European Union. Jarvik Heart ran a 150-patient pivotal trial for bridge-to-transplant therapy in the U.S., according to a press release.