The federal watchdog referenced specific issues with both approved implantable LVADs: Thoratec’s HeartMate II and HeartWare’s HVAD system.
Adverse events referenced included increased rate of pump thrombosis with the HeartMate II and a high rate of stroke with HeartWare’s HVAD, as well as bleeding complications associated with both devices.
The FDA said they have received reports and information from a “variety of sources indicating an increase in the rate of pump thrombosis events in patients implanted with the HeartMate II,” according to the release.
Patients are experiencing pump thrombosis events earlier than observed during clinical trials, the FDA said, citing 2 analytical scientific reports that pegged the rate to be as high as 8.4% of implanted devices at 3 months and 6% of devices at 6 months. This is much higher, the federal watchdog said, than the 1.6% rate at 1 year and 3.8% at 2 years that was reported during the clinical trials of the device.
Pump thrombosis is “a serious complication that can require repeat surgery to replace the pump or can lead to death,” the FDA said.
The FDA went on to reference recent results from a clinical trial of HeartWare’s HVAD in which 28.7% of patients reported 1 or more strokes over 2 years, significantly higher than the 12.1% rate for patients with the control device.
The federal watchdog offered the caveat that the HeartWare study was investigating the device as a destination therapy, which it is currently not indicated for, but offered that the device itself was the same as is used for its currently cleared bridge-to-transplant indication.
Bleeding complications were mentioned for both devices. The FDA said they had received reports of bleeding issues through adverse event reports and information from “a variety of sources,” for the devices.
The cause of these complications is not fully understood, the agency said, but could have something to do with modification of anticoagulation therapy to lower risks of pump thrombosis.
The terms of the deal call for St. Jude to pay $63.50 in cash for each share of Pleasanton, Calif.-based Thoratec, funded using term loans and senior unsecured debt, Little Canada, Minn.-based St. Jude said. Rumors about a possible deal surfaced earlier in July.