Vascular Dynamics, Inc (VDI), based in Mountain View, California, was one of the nine companies chosen in 2012 by the FDA to participate in the Early Feasibility Study Investigational Device Exemption (IDE) Pilot Program. VDI is conducting clinical trials in the US and Europe to evaluate the safety and performance of the MobiusHD™ device. The studies are open-label, controlled, multi-center, first-in-human clinical trials.
The studies are being conducted in up to ten centers in the US and currently eight centers in the EU. The CALM-FIM_US Study represents one of the first FDA approvals of an IDE following the FDA’s issuance of draft guidance on IDEs for early feasibility studies. The intent of FDA’s guidance is to foster early-stage development of medical devices within the US to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable.