InThrill™ Thrombectomy System

The InThrill™ Thrombectomy System is a minimally invasive catheter-based device designed to remove blood clots (emboli and thrombi) from peripheral blood vessels, including dialysis access grafts and synthetic grafts. It comprises an 8 Fr sheath and an 8 Fr catheter that work together to capture and extract clots, and can also be used for injection or aspiration of contrast media and other fluids.

The subject device differs from the predicate in: a longer sheath tip taper; changes to the coring element (longer length, smaller diameter, different geometry); decreased Pebax durometer at the sheath shaft tip and increased durometer at the catheter shaft tip; a change from two coaxial braided shafts to a single, thicker shaft; and the addition of an element support tool accessory. Shelf-life is 6 months versus 2 years for the predicate. Product codes expand from QEW, KRA to QEW, KRA, DYB.

ISO 10993-1 (biocompatibility), ISO 11135:2014/Amd 1:2018 (sterilization by ethylene oxide), and AAMI TIR 28:2016 (sterilization standards). Testing included biocompatibility assays (cytotoxicity, sensitization, thromboresistance), performance verification (dimensional, hemostasis, tensile, torque, corrosion), and system validation (clot removal efficacy, deployment, leak testing).

The device has identical intended use and principles of operation as the predicate (same indications, peripheral vasculature use, same guidewire compatibility). Although dimensional and material modifications were made, comprehensive non-clinical performance testing demonstrated all acceptance criteria were met and that these design changes do not raise new or different safety or effectiveness concerns. The biocompatibility and sterilization processes meet established standards, and the device maintains functional equivalence for clot removal despite the engineering refinements.