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The FLEX Vessel Prep™ System is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and poplited arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.

The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. The FLEX Vessel Prep™ System is advanced over a 0.014" or 0.018" quidewire until distal to the lesion to be treated. The Treatment Element is unsheathed and expanded. The Treatment Element consists of three independent flexible struts, each with a precision blade, mounted on the proximal end. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled-depth microincisions. The Flex Vessel Prep™ System is available in 2 lengths, 120cm and 40cm. The device has a 2mm crossing profile and is compatible with 6 French introducer sheaths. It is recommended to use a 150 cm+ guidewire with the 40cm product and a 300cm guidewire with the 120cm product. The device consists of three integrated components. The Control Handle, which contains a Guidewire Port for quidewire insertion, a Flush Port to flush with saline to remove air from the device, the Sheath Actuator and Treatment Element Actuator. The Sheath Actuator is located on the flat surface of the handle below the word FLEX. When the Sheath Actuator is pulled back and held in place, the sheath covering the Treatment Element is retracted and the Treatment Element is exposed. A click verifies the sheath is fully retracted. The Treatment Element Actuator is located on the curved aspect of the handle, above the word FLEX. When the Treatment Element Actuator is pulled back and held in place, the Treatment Element expands the 3 flexible struts of the Treatment Element. The Reinforced Braided Shaft, which is enclosed within a clear polymer sheath, provides strength to enhance deliverability and torque performance of the device. The distal end of the device contains a radiopaque marker to aid in positioning the catheter and the Treatment Element. The Treatment Element consists of three precision blades. 10 thousandths of an inch (0.010") in height and mounted on the proximal end of each of the three independent flexible struts. The expansion of the Treatment Element allows the three precision blades to independently engage the lesion. During the retrograde pull-back of the device, each strut of the protective Treatment "flexes" independently to provide continuous engagement along and through complex lesions to create controlled-depth micro-incisions along the lesion. These micro-incisions modify the plaque in the lesion and enable dilatation of the target lesion using percutaneous angioplasty balloons at lower inflation pressures, minimizing barotrauma to the vessel.