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The standard endovascular treatment for obstructed peripheral arterial disease (PAD) lesions and stenosed arteriovenous (AV) fistulae is percutaneous transluminal angioplasty (PTA). Despite consistent effectiveness in restoring blood flow, PTA does introduce risk of uncontrolled dissections that require stenting. The FLEX Vessel Prep™ System (FLEX VP) is a novel, dynamic, self-sizing, nonballoon device designed to modify obstructive stenoses and plaque, improve vessel compliance and facilitate delivery of drug therapies by creating longitudinal, controlled-depth, circumferential microincisions along the entire length of a lesion. In this profile, the mechanism of action of the FLEX VP system is described and differentiated. Acute procedural complications and long-term clinical outcomes following FLEX VP+PTA are presented. Specifically, the unmet clinical need for safe and effective vessel preparation in long, complex, mixed morphology PAD lesions is highlighted. The FLEX VP system is an innovative approach to create predictable and consistent longitudinal microincisions in long lesions that improve acute luminal gain and vessel compliance by releasing circumferential tension in the lesion. This nonballoon-based device for plaque modification is safe, effective, easy-to-use, and minimizes PTA-associated dissections, therefore reducing stenting, supporting the ‘leave nothing behind’ incentive of physicians, and improving long-term clinical outcomes with less vessel trauma.

Device profile of the FLEX Vessel Prep System for the treatment of peripheral arterial disease: overview of its safety and efficacy