Maestro Rechargeable: Pivotal trial data
Top-line data from 239 patients in the intent-to-treat (ITT) population of the double-blind, U.S. and Australian ReCharge pivotal trial showed that VBLOC vagal blocking therapy delivered with the company's Maestro RC System missed the co-primary endpoints of 55% of patients achieving >=20% EWL and 45% of patients achieving >=25% EWL (52.5% and 38.3%, respectively). EnteroMedics said the differences on both endpoints were significant compared to the sham control group which received a non-functional device (32.5% and 23.4%, respectively, p=0.004 and p=0.02). VBLOC therapy also significantly improved mean EWL vs. sham control (24.4% vs. 15.9%, p=0.002), but failed to meet the pre-specified hurdle of a 10% difference from control (p=0.705). ...