The device will be compared to treatment with non-vitamin K antagonist oral anticoagulants (NOACs), considered the leading contemporary drugs for stroke risk reduction in this population.

Selective Cytopheretic Device study’s primary objective was to assess the safety of the device in children. Safety was determined by adverse events related to treatment up to 60 days following treatment initiation.

The purpose of the meeting was to finalize the protocol (procedure) for its new clinical study in support of its Premarketing Application for the LuViva® Advanced Cervical Scan (i.e., FDA approval). The Company filed the minutes from this meeting with FDA yesterday, which the agency will review and provide any final comments on the meeting and study protocol.

IN.PACT BTK study is a prospective, multi-center, 1:1, randomized feasibility study assessing the safety and effectiveness of the IN.PACT 0.014 DCB, a 3.5 μg/mm2 dose paclitaxel-coated balloon, versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of CTOs in the infrapopliteal arteries. The study enrolled 50 subjects at nine sites in Europe.