Transluminal Technologies completes the First-in-Man study of the velox LB vascular closure device
Asuncion, Paraguay, April 20, 2017 – Transluminal Technologies, LLC, a Syracuse, NY-based medical device company has announced today that they have successfully completed the First-in-Man clinical study of the velox LB large bore vascular closure device with 100% procedural success (10/10).
Methods: Patients with a baseline common femoral artery (CFA) diameter of ≥ 6.0 mm were anti-coagulated with IV heparin and treated with ≥14 FR arterial sheaths. Examination of the arterial closure site, distal pulses and vascular ultrasound were performed pre-procedure, immediately post procedure and at 24 hr post procedure. Procedural success was defined as cessation of access site bleeding within 10 min without vascular complication. Device success was defined as implant deployment and cessation of access site bleeding within 10 min. without vascular complication.
Results: Patient characteristics are found in table below. Procedure success rate was achieved in 10 patients (100%). Device success was achieved in 9 patients (90%). The device was not deployed in one patient due to operator failure to follow the IFU.
Time to cessation of bleeding overall was 3.1 ± 3.1 min. and was 2.4 ± 2.4 min. in patients with device success. There was no change in the quality of pedal pulses in any patient following device deployment. There was no change in the mean diameter of the common femoral artery either immediately, post procedure or at 24 hr. Nine of ten patients were allowed to get out of bed at 2.0 ± 0.3 hr post procedure. All patients were ambulating at 24 hr. There was no complaint of any significant groin discomfort at 24 hr.
Conclusion: In this FIM study the Velox LB VCD demonstrated rapid and effective large bore arteriotomy closure without compromise of the femoral arterial lumen for all patients in whom the device was successfully deployed. The magnesium alloy was well tolerated.
velox LB is for investigational use only