Initial Study of New Device for Vessel Prep: BELONG Study 12-month Results

Vessel preparation creates an optimal environment for primary therapy, such as angioplasty, drug-coated balloons (DCB), and stenting, according to Eric Secemsky, MD, Director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts. Some of the advantages of vessel prep include improved vessel compliance, lower balloon pressure required for lesion effacement, increased luminal gain, facilitated drug transfer, minimal adverse events (dissection, embolization, perforation), and decreased need for stenting.

The FLEX Vessel Prep™ System (VentureMed) is an over-the-wire sheath catheter with an atraumatic tip, flexible struts, and 3 surgical micro-blades. BELONG was a single-center, single-arm, prospective study that enrolled 41 patients with superficial femoral artery and popliteal artery stenosis who were eligible for FLEX/angioplasty treatment.

In BELONG, lesions in the superficial femoral artery accounted for 86% of cases and popliteal lesions accounted for 14%. The average stenosis was 81.8% at baseline. The average residual stenosis post-FLEX and post–drug-coated balloon was 62.8% and 33.6%, respectively. Most stented lesions had a PACSS Score ≥3.

The 12-month results showed 100% procedural success. The average number of FLEX passes was 4. There was no perforation and 100% outflow was confirmed, with 1 distal embolization observed after DCB that was successfully aspirated. There was successful lumen gain—reduction of residual stenosis from 81.8% to 62.5% post-FLEX alone and from 62.5% to 34.2% post-DCB.

The 12-month efficacy results showed 97.5% (39/40) freedom from clinically-driven target lesion revascularization, 84.2% (32/38) freedom from target lesion restenosis via duplex (PSV >2.5), and 100% freedom from major amputation. Compared to debunking studies with similar lesion populations (REALITY), FLEX and DCB demonstrated improvement in patient Rutherford class at 12 months. A 15% Rutherford class 4-5 at baseline improved to 90% Rutherford class 0-1 in BELONG vs 76% in REALITY.

Further studies with DCB therapies should be considered to further evaluate the success of this option and the impact of FLEX enhancing drug delivery.