EuroPCR 2017 Roundup: Boston Scientific ’ s Lotus beats Medtronic ’ s CoreValve in head-to-head study

Boston Scientific (NYSE:BSX) said its Lotus replacement heart valve beat the competing CoreValve device made by Medtronic (NYSE:MDT) in a head-to-head trial. Data from the Reprise III study, billed as the 1st head-to-head pivotal trial comparing transcatheter aortic valve replacements, were released today at the annual EuroPCR meeting in Paris. The 912-patient study compared Lotus with the CoreValve and CoreValve Evolut devices in high- and extreme-risk patients. The primary efficacy endpoint was the composite rate of death, disabling stroke and moderate or greater paravalvular leakage at 1 year; the primary safety endpoint was a composite rate of all-cause mortality, stroke, life-threatening and major bleeding, stage 2 or 3 acute kidney injury or major vascular complications at 30 days. Boston Scientific said the Lotus valve showed superiority on the efficacy endpoint of 16.7%, compared with 29.0% for the CoreValve arm. On the safety endpoint, Lotus showed non-inferiority to CoreValve, the Marlborough, Mass.-based company said. A secondary endpoint, the rate of moderate to severe PVL, was 2.0% for Lotus and 11.1% for the CoreValve-treated cohort, Boston Scientific said. “We are very excited by the performance of the Lotus valve system in this trial as it represents a crucial piece of clinical evidence for the Lotus platform,” global CMO Dr. Ian Meredith said in prepared remarks. “We believe that these data, along with upcoming findings to be shar...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Boston Scientific Edwards Lifesciences europcr2017 Medtronic Source Type: news