Jarvik Heart has obtained regulatory approval for its Jarvik 2000 Heart, a left ventricular assist device (LVAD) implanted inside the heart, from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
On November 22, Shonin approval was granted based on Japanese and US clinical trial data of the device, approving it as a bridge to transplant. Century Medical will be the exclusive distributor of Jarvik 2000 in Japan.
At only 30cc volume and 90g (about the size of a C-cell battery), the Jarvik 2000 can support the hearts of patients only 4ft 6in tall and weighing less than 85lb.
However, the same blood pump can also support large patients taller than 6ft 2in and weighing more than 225lb.
While the pump is operated at slower speeds for smaller patients, it is operated at higher speeds in larger patients.
The Jarvik 2000 is reportedly the smallest LVAD approved for long-term use in Japan, where there is an extended waiting time for donors.
Japanese patients testing the LVAD have successfully worn it for up to four years before receiving a successful heart transplant from a donor.
Unlike Thoratec's HeartMate II, the Jarvik 2000 uses a unique behind-the-ear power cable and has no pump pocket, which helps reduce infection rates and also boost patients' quality of life.
Jarvik Heart recently completed enrolment and follow up to outcome of its 150-patient Bridge to Transplant study, while a randomised 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 the implant and for absence of infection at three years.
According to the company, 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 high quality of life.
Previously, the Jarvik 2000 Heart also obtained CE mark approval in Europe.
The company is currently working with the support of the National Heart, Lung, and Blood Institute (NHLBI) under the PumpKIN programme (Pumps for Kids, Infants, and Neonates) in developing a paediatric version of Jarvik 2000 for use in infants, with a multicentre clinical trial planned for 2014.
Image: The Jarvik 2000 heart includes the blood pump inside the natural heart (white arrow), the internal cable (blue arrow), the behind-the-ear connector (green arrow) the belt worn controller (yellow arrow), the belt worn battery (grey arrow), and the external cables (black). Photo: courtesy of Jarvik Heart, Inc /PR Newswire.