MDT Single-Arm US Pivotal Trial Goes Better Than Expected, Jefferies Reports

Jefferies is reporting that Medtronic's MDT single-arm (versus a historical control) US pivotal trial for its next-generation RESOLUTE DES “achieved its primary endpoint of TLF non-inferiority in both the clinical and angiographic cohorts.” “Importantly, the trial demonstrated very favorable safety outcomes including a stent thrombosis rate of just 0.1%, which clinicians highlight as a very favorable result and potentially an important attribute of the device from a competitive standpoint,” Jefferies writes. “The low stent thrombosis rate seen in RESOLUTE US could yield some upside for Medtronic relative to our current US market share assumptions. Medtronic noted the PMA for Resolute was filed with FDA last week on both the flagship Driver and the newer Integrity stent platforms; as such, US approval is expected by mid-CY12. In Japan, the company expects to file Resolute for Shonin approval in 1Q FY12.”