HeartWare International, a developer of less invasive, miniaturized circulatory support technologies in the treatment of advanced heart failure, has received FDA approval for Ventricular Assist System as an investigational device exemption (IDE) supplement.
FDA approval allows HeartWare to enroll up to an additional 54 patients in its ‘Advance’ bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).
The HeartWare Ventricular Assist System features HVAD pump, a small full-output circulatory support device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. HeartWare has received CE Marking in the European Union. The device is currently the subject of a US clinical trial for a bridge-to-transplant indication.
The primary endpoint of the trial is survival at 180-days, defined as alive on the originally implanted device or transplanted or explanted for recovery. The secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.
HeartWare said that under the Advance study, 140 patients at 30 US clinical sites received HeartWare HVAD pumps, making it the largest bridge-to-transplant pivotal trial to date. The final implant in Advance was conducted on February 25, 2010, which will result in the final patient reaching the 180-day follow up point by the end of August 2010.
Patient enrollment under the CAP is expected to commence at the 30 centers participating in the Advance clinical trial, subject to institutional review board approvals at the centers. The CAP patients will be enrolled and followed under a modified protocol of the Advance trial. HeartWare anticipates submission to the FDA of the PMA seeking approval of the HeartWare System for the bridge-to-transplant indication in December of this year.
HeartWare develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IV patients suffering from advanced heart failure.