Medtronic touts stroke data for HeartWare LVAD

A retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump. The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said. The 465-patient Endurance Supplemental study compared 308 patients implanted with the HeartWare HVAD and 157 patients implanted with arch-rival Thoratec‘s HeartMate II device; the HVAD-treated cohort was also managed with a pre-specified blood pressure strategy to try to cut the stroke rates seen in earlier trials. Endurance Supplemental’s primary endpoint was the rate of transient ischemic attack or stroke with 24-week residual deficit at 12 months. Secondary endpoints included a composite of freedom from death, disabling stroke and device replacement or urgent transplantation and a comparison of stroke or transient ischemic attack between the HVAD-treated cohorts in Endurance Supplemental and the original Endurance trial. Although Endurance Supplemental missed the primary endpoint, with a 14.7% stroke rate for the HVAD cohort and 12.1% for the HeartMate II group, HVAD patients a 76.1% rate of freedom from the ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Clinical Trials Featured Abbott HeartWare International Inc. Medtronic stjudemedical Thoratec Corp. Source Type: news