HeartWare Begins Trial of New VAD Implantation Technique
HeartWare International said Tuesday that the first HeartWare Ventricular Assist System featuring the HVAD Pump was successfully implanted in its HVAD LATERAL IDE clinical trial. The study will assess the outcomes of heart transplant candidates who receive the device via a thoracotomy.
Currently, ventricular assist devices are only FDA-approved for implantation by median sternotomy, which requires opening up the patient’s chest. Thoracotomy allows the small HVAD Pump to be implanted through an incision between the patient’s left ribs, the Framingham, Mass., company said.
Implanting the device by means of a thoracotomy is easier for the surgeon and better tolerated by the patient, said Ed McGee, head of the heart transplant and assist device program at Loyola University in Chicago.
The trial will enroll up to 120 patients at 30 U.S. hospitals, HeartWare said. The primary survival endpoint will be measured at six months post-implant. — Kellen Owings