Acute Outcomes With a Novel Plaque Modification System in Real-World Femoropopliteal Lesions

Area of Science:

• Vascular surgery
• Interventional cardiology
• Medical device technology

Background:

• Femoropopliteal artery disease often involves long, complex lesions requiring advanced treatment strategies.
• Current angioplasty techniques may face challenges with significant stenosis and chronic total occlusions.
• Novel vessel preparation technologies are needed to improve procedural outcomes.

Purpose of the Study:

• To evaluate the feasibility and acute outcomes of the FLEX Vessel Prep (VP) System for plaque incision and lumen gain.
• To assess the safety and efficacy of the FLEX VP System in preparing stenosed or occluded femoropopliteal arteries prior to angioplasty.
• To determine the rate of provisional stenting and identify predictors of its use after FLEX VP System preparation.

Main Methods:

• A multicenter feasibility study involving 255 patients treated with the FLEX VP System.
• Lesions included stenoses (average 92%) and chronic total occlusions (44.3%).
• Angiographic outcomes were analyzed post-FLEX VP System passage and post-angioplasty/stenting.

Main Results:

• The FLEX VP System achieved an average 27% reduction in stenosis.
• No flow-limiting dissections, perforations, or embolizations occurred; minor dissections in 5.9% of patients.
• Provisional stenting was required in 19.2% of patients, with 3.6% having significant residual stenosis.

Conclusions:

• The FLEX VP System is a feasible technology for preparing complex femoropopliteal lesions.
• It improved acute outcomes compared to historical controls with a low provisional stenting rate.
• The system demonstrated a favorable safety profile, with no major vessel complications observed.