FLEX Vessel Prep System Acute Results in Complex Vessel Anatomy

Purpose: Treatment of complex superficial femoral and popliteal artery lesions is limited by restenosis. Acute treatment results reduces the probability of restenosis. Plaque modification before angioplasty has the potential to improve acute results, decrease the need for reinterventions, and improve the patients quality of life. Vessel prep with the FLEX Vessel Prep (VP) system has demonstrated improved vessel compliance, reduced dissection rate, severity, and the need for stenting and improved overall acute results. A multi-center retrospective review was conducted on 185 real-world cases with long (8-cm) chronic total occlusions (CTOs).

Materials and Methods: The FLEX VP system is an intuitive device with a dual mechanism of action that modifies plaque while preparing the vessel for revascularization. The system uses an expandable treatment element with three atherotomes that engage the contour of vessel morphology, creating longitudinal, controlled-depth microincisions in the plaque while simultaneously predilating the lesion. A retrospective review of 185 long CTOs in real-world patients was analyzed. Only lesions prepped with the FLEX VP system before angioplasty were included.

Results: The retrospective review included 185 CTOs with a lesion length greater than 8 cm. The FLEX VP system created a mean luminal gain before angioplasty of 34%. The effacement pressure, the lowest pressure required to fully efface the lesion, was on average subnominal at 4 atm. The low inflation pressures suggest an improvement in vessel compliance, attributed to the vessel preparation. There were a small number of dissections noted in these complex lesions, 4% (grade A or B only). There were no flow-limiting dissections, perforations, or embolizations, and provisional stenting was used in only 28% of cases in these long complex lesions.

Conclusions: This multicenter retrospective review illustrates that the use of the FLEX VP system contributed to satisfactory acute outcomes in real-world complex lesions. Revascularization was successful in all 185 CTOs reviewed with no major complications. After treatment with the FLEX, vessel compliance was noted to have improved because of the subnominal inflation pressures. Further studies are warranted to confirm if these promising acute results decrease the need for reinterventions long term. The FLEX VP system effectively treats complex lesions in the superficial femoral and popliteal arteries, potentially decreasing the risk of major complications.