Dual Mechanism of Action
The FLEX Vessel Prep™ System predictably modifies plaque with control to prepare lesions prior to treatment. The FLEX dual mechanism of action combines longitudinal micro-incisions with radial force expansion that is optimized for retrograde pull-back to balance safety and efficacy while minimizing the risk of embolization.
With its radially opposed tri-element atherotomes mounted on protective skids, the FLEX Vessel Prep™ System delivers long, parallel, micro-incisions, modifying plaque in any lesion length and morphology with a simultaneous outward radial force pressure providing proprietary control on the depth of the micro-incision. FLEX is unlike traditional static or focal force scoring devices that requires balloon apposition to force the scoring element into the lesion. The FLEX device “flexes” and glides along the contour of the lesion in all plaque morphologies. One SKU for any lesion.
Non-Balloon Based Technology
The FLEX Vessel Prep™ System exerts a consistent force of approximately one atmosphere (ATM) on the vessel wall as it glides along the vessel and plaque. Low forces help prevent soft tissue damage that can lead to sub optimal acute results, including dissection and the need for bail out stent placement. The FLEX Vessel Prep™ System also demonstrates exceptionally low rates of embolization for safer procedures.
Pull Back Technique
The integrated tip and low crossing profile of the FLEX Vessel Prep™ System allows the device to smoothly navigate the vessel. Once distal to the area being treated, the FLEX Vessel Prep™ System atherotomes are unsheathed, actuated via the finger lever, and the device is pulled back through the diseased vessel where the treatment element “flexes” and guides along the contour of the plaque and vessel being prepped.