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news.Australia-based HeartWare has received conditional approval from the FDA of an investigational device exemption for the company's lead product, the HeartWare Left Ventricular Assist System.
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The granting of conditional investigational device exemption (IDE) approval by the FDA enables the company to immediately commence its US clinical trial for the HeartWare Left Ventricular Assist System (LVAS) for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure.
HeartWare’s Bridge-to-Transplant (BTT) pivotal clinical trial will enroll up to 150 patients across a maximum of 28 centers. 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.
The study includes a contemporaneous control group. Patient outcomes will be compared to those of a matched cohort of patients recorded in the InterAgency Registry for Mechanical Assisted Circulatory Support (INTERMACS). 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. Patients enrolled in the HeartWare trial will be eligible for discharge from hospital immediately following their implant.