WorldHeart gets US OK to accelerate heart pump destination therapy trial:
This article was originally published in Clinica
WorldHeart may have moved closer to taking its pulsatile heart pump to the US destination therapy market, after the FDA said it could make timesaving modifications to a clinical trial of the device. Trial design changes expected to accelerate the study's completion include a sample size reduction from 390 to 208 patients and broader patient inclusion criteria that should speed up the patient enrolment rate. The trial, called RELIANT Destination Therapy, is assessing the firm's Novacor left ventricular assist system and has already enrolled nearly 20% of the newly required number. The FDA has already approved the device as a bridge to transplantation.