Jarvik Heart's Japan regulatory win gives Thoratec a new heart pump challenge

The Jarvik Heart, which, unlike other devices designed to treat heart failure, has a behind-the-ear power cable, has just been approved in Japan.--Courtesy of Jarvik Heart

Jarvik Heart won Japanese regulatory approval for its left ventricular assist device (LVAD), bringing its heart pump rivalry with Thoratec ($THOR) to Asia.

Japan's Pharmaceuticals and Medicines Devices Agency signed off on the Jarvik 2000 Heart based on Japanese and U.S. clinical trial data, approving it as a bridge to transplant. Century Medical will be the exclusive distributor of the device.

This is a win for the privately held Jarvik on multiple levels. For one thing, Japan is one of the largest healthcare markets in the world outside of the United States. And as the New York company noted, Japan has an extended heart transplant waiting list. Patients testing the implant there have successfully worn it for up to four years before receiving a successful heart transplant, Jarvik said. And the company touts the device as being the smallest LVAD approved in Japan for long-term use. It is certainly novel--unlike Thoratec's HeartMate II, the Jarvik 2000 lacks an abdominal power cable and pump pocket. It relies on a behind-the-ear power cable that Jarvik said will help slash infection rates and also boost patients' quality of life.

In Europe, the Jarvik 2000 is CE marked. Clinical trials continue in the U.S., where Jarvik completed a 150-patient pivotal trial for bridge-to-transplant evaluating its device against the HeartMate II. Plans call for evaluating more than 300 patients' survival rates up to two years after their implant and infection rates for three years.

Thoratec's HeartMate II is one of the most widely used LVAD devices, and the California company won approval last year in Japan to market it as a bridge-to-transplant for heart failure patients. So Jarvik's entry into the Japanese market ups the competition considerably. Jarvik appears to be gearing up for the challenge: It will compete with Thoratec in the U.S. once it receives approval, and the company is even working on developing a pediatric version of Jarvik 2000 for use in infants, with a multicenter clinical trial planned for 2014.

Thoratec's HeartMate line generates the bulk of the company's revenue, which continues to soar in the absence of major competition. But there are some chinks that could hurt that growth down the line, most recently some new research published in The New England Journal of Medicine that linked HeartMate to blood clots. Jarvik's entry into Japan could start to put a dent in HeartMate's status as a growth engine, and its eventual U.S. approval could add additional fuel to the fire in the months ahead.

- read Jarvik's release