FDA Gives HeartWare IDE for LVAS Trial

 

May 6, 2008

May 5, 2008 - HeartWare Ltd. received conditional approval from the FDA of an Investigational Device Exemption (IDE) for its lead product, the HeartWare Left Ventricular Assist System (LVAS), enabling the company to commence its U.S. clinical trial for the HeartWare LVAS for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure.

Some of the key elements the HeartWare's Bridge-to-Transplant (BTT) pivotal trial include:

- The primary endpoint is survival at 180 days. This survival endpoint is specifically defined to include patients who have received a heart transplant, patients who remain alive and supported by the device at 180 days and recovery patients who have survived for a minimum of 60 days following the explant of their device.

- Patient outcomes will be compared to those of a matched cohort of patients recorded in the InterAgency Registry for Mechanical Assisted Circulatory Support (INTERMACS).

- The trial requires the enrollment of up to 150 patients across a maximum of 28 centers.

- HeartWare is permitted to open up to 10 centers immediately. Once 10 patients have been enrolled and supported with the HeartWare LVAS for a mean period of 90 days, the company will submit a clinical safety report to the FDA for review. Enrollment will continue unabated at the initial 10 centers during this review period. Subject to FDA approval of the clinical safety report, enrollment can then be expanded to all 28 centers.

- Patients enrolled in the HeartWare pivotal trial will be eligible for discharge from hospital immediately following their implant.

For more information: www.heartware.com