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).

Keywords

• 3D-printing
• Bioresorbable stent
• Drug eluting stent
• Superficial femoral artery arteriosclerosis obliterans