The FLEX Vessel Prep™ System

The FLEX Vessel Prep™ System

The FLEX Vessel Prep™ System is an over-the-wire, retractable sheathed device designed to prepare an ideal vessel environment to facilitate angioplasty.

View Instructions For Use   |   View FLEX Label

Arteriovenous Device Animation

FLEX Features & Specifications

Ergonomic Handle Design

Ergonomic Handle Design

  • Provides a comfortable, easy-to-use grip with sturdy finger and thumb triggers

6 French Sheath Compatibility

6 French Sheath Compatibility

  • Offers the flexibility to use with either a 0.014" or 0.018" guidewire

Low Crossing Profile

Low Crossing Profile

  • Delivers treatment element safely and efficiently to the lesion area with a low crossing profile of 2.0 mm

The FLEX VP™ System Difference

Optical Coherence Tomography (OCT) image showing the defined scores created by the FLEX VP™ System along the plaque wall.

Optical Coherence Tomography (OCT) image showing the defined scores created by the FLEX VP™ System along the plaque wall.

Histology study showing the effect of the FLEX VP™ System and the controlled scoring depth.

Histology study showing the effect of the FLEX VP™ System and the controlled scoring depth.

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.

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