Pleasanton, Calif.-based Thoratec said the safety phase of the U.S. study, comparing its already-approved HeartMate II left ventricular assist device with the HeartMate III, is slated to enroll up to 30 patients at 5 sites under a conditional approval from the FDA. If the 30-day follow-up data from the safety phase earns the FDA’s approval, enrollment of another 366 patients at 60 sites is planned, according to a press release. The 1st 294 patients will be followed for 6 months to evaluate the HeartMate III for bridge-to-transplant therapy; the 1st 366 enrolled will be followed out to 2 years to evaluate the device for a destination therapy indication, according to the release. And another 600 patients could be enrolled after the pivotal cohort to assess secondary endpoints, Thoratec said.
The U.S. trial’s primary endpoint is survival free of device replacement and debilitating stroke, Thoratec said. In comparison, the 50-patient European trial includes a primary endpoint of 6-month survival compared with estimated mortality based on the Seattle Heart Failure Model.
"We are excited to continue our recent pipeline progress with the start of the U.S. clinical trial for HeartMate III," president & CEO Gary Burbach said in prepared remarks. "Our innovative U.S. trial design allows for the evaluation of patients for both short-term and long-term support, and we are particularly enthusiastic about the potential for HeartMate III to drive future growth of both the LVAD market and Thoratec."
The latest iteration in the HeartMate line harnesses the magnetic levitation technology acquired from Levitronix back in 2011. It’s designed to lower adverse event rates via "improved hemocompatibility," the company said in June. Thoratec paid $110 million up front for the Levitronix magnetically levitated bearing-free motors technology in August 2011, putting another $40 million in potential earnouts on the table.
The 1st patient in the U.S. trial was implanted by Dr. James Long of the Integris Baptist Medical Center in Oklahoma City, who participated in prior trials of Thoratec’s HeartMate devices, according to the release.
"We look forward to further enrollment in this important study for the field, and the opportunity to demonstrate the potential benefits of the unique fully magnetically levitated technology of HeartMate III," Long said in a statement.
THOR shares were up 1.5% to $25.73 apiece on the news as of about 10 a.m. Eastern today.