Flexible Stenting Solutions has reported that Andrew Holden of Auckland City Hospital has presented results of Final first-in-man (FIM) clinical study, conducted in New Zealand, on the use of the FlexStent Femoropopliteal SE Stent System.
The clinical results from Flexible Stenting Solutions’ supplementary study conducted in Germany were presented by principle investigator Dierk Scheinert of University of Leipzig – Heart Center.
The primary objective at both sites was to evaluate the safety and efficacy of the FlexStent as measured by the Freedom from Major Adverse Cardiac Events (MACE) at 30 days and the absence of in-stent binary restenosis (patency) using duplex ultrasound (DUS) at 1, 6, 12 and 18 (NZ only) month intervals.
The Freedom from MACE was 100% at all visits and the patency at 12 months was 85.2% for an average lesion length of 84 mm.
The results at 18 months from New Zealand show for continued efficacy and the absence of stent fracture was shown through all visits using standard x-ray evaluation methods.
Holden said that the mid-term clinical results of the Flexstent are encouraging and the resistance to fracture is a strong feature of this stent.
Flexible Stenting Solutions CEO Janet Burpee said that the fully connected stent offers the atraumatic solution needed in the femoropopliteal arteries, and are enthusiastic to start US clinical trial.