Jarvik moves toward FDA nod for cardiac assist device

Unlike other devices designed to treat heart failure, the Jarvik Heart has a behind-the-ear power cable--courtesy of Jarvik Heart

Jarvik Heart is inching toward approval for its Jarvik 2000 device, getting full FDA approval for a pivotal trial that will use the device in heart failure patients not eligible for transplant.

With the FDA's approval in hand, Jarvik will begin a pivotal trial of up to 350 patients at 50 medical centers that will begin enrollment immediately, the company said. The trial will compare Jarvik's device against Thoratec's ($THOR) HeartMate II, the most widely used tech for destination therapy.

Jarvik hopes the two-year trial finds its device better than, or equivalent to, HeartMate II at the primary endpoint of survival, without disabling complications. And the company is banking on the Jarvik 2000's novel construction to prove superior in limiting the risk of infection. Unlike the HeartMate II, Jarvik's tech has no abdominal power cable and pump pocket, using instead a behind-the-ear power cable the company says will cut down on any serious infection risk.

The Jarvik Heart has already been used to treat more than 200 patients in Europe, the company said, and patients there experienced low rates of infection and no cases of mechanical or cable failure. Furthermore, the device's behind-the-ear power feature brought them significant quality-of-life boosts over other devices, requiring little to no care of the cable exit site and, unlike devices with abdominal cables, no sterile bandage redressing.

- read Jarvik's release

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