First-in-human Implantation of a 3D-printing Fully Bioresorbable Drug Eluting Stent for Treatment of Superficial Femoral Artery Disease

Abstract

Background

Bioresorbable stent (BRS) is ideal treatment for superficial femoral artery (SFA) arteriosclerosis obliterans, allowing the target vessel to return to its normal state. A 3D-printing Fully Bioresorbable Drug Eluting Stent (PERISORB® BRS) was implanted for a successful first-in-human treatment of a SFA obstruction.

Methods

A 57-year-old female patient suffered from intermittent claudication Rutherford-Becker category 3, the ankle-brachial index (ABI) was 0.70. Pre-procedure CTA showed a calcified 50 mm long severe stenosis in the distal segment of the left SFA.

Results

The lesion was dilated with a diameter of 5 mm balloon, no relevant residual stenosis but a local dissection was seen during control-angiograms, the dissection was treated by implantation of a 5 mm × 76 mm 3D-printing biodegradable drug-eluting peripheral stent (PERISORB® BRS). The patient returned for follow-up visits, color duplex ultrasonography (CDUS) and digital subtraction angiography (DSA) was performed at 6-month and 16-month follow-up. No perioperative complications were found. At 16-month follow-up, ultrasonography showed stent patency and no stenosis. The Rutherford-Becker category was 1 and the ABI improved to 0.85.

Conclusion

A successful first-in-human implantation was performed with the 3D-printing biodegradable drug-eluting peripheral stent (PERISORB® BRS).