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The Santreva™-ATK Endovascular Revascularization Catheter is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including Chronic Total Occlusions (CTOs), in the femoropopliteal (arterial) peripheral vasculature.

Santreva™-ATK Endovascular Revascularization Catheter ("Santreva-ATK") consists of:

1. a distal end mechanism of simultaneous plaque-puncturing, lateral plaque displacement, and plaque compression by a distal tip to form a channel,
2. an intraluminal control mechanism for intraplaque traversal of the distal tip,
3. an outer catheter shaft,
4. an inner torque cable tube with guidewire lumen, and
5. a proximal end handle with integrated torque wheel for manual rotation of the torque cable.

The handle has a luer for introduction of a guidewire through the handle and the torque cable for placement into distal true lumen after Santreva-ATK traverses and recanalizes the plaque without a wire.

The distal catheter has a rotating tip with an integrated cutting loop to puncture, displace, and compress the plaque as the mechanism of CTO crossing in combination with a centering system component to maintain the catheter in the intraluminal and intraplaque position. The centering system component has three collapsible wings and in combination with the distal tip advances into the open lumen of the vasculature and within the CTO which may facilitate formation of an intraplaque and angiographically visible channel. The collapsible centering system wings are sloped in each direction to present a tapered interface to both the CTO body plaque and to the support accessories such as guide catheters or guiding sheaths during advancement and retraction of the catheter.

After delivery of the Santreva-ATK distal catheter tip to the CTO lesion, the operator pushes the outer catheter shaft in the distal direction with one hand, while rotating the handle wheel with the other hand, such that the tip and cutting loop combination punctures the CTO cap. Continued push and rotation of the tip and cutting loop combination recanalizes the CTO plaque with simultaneous radial displacement and compression. As the operator advances the device through the CTO body, the plaque is further compressed laterally by the centering system wings, thereby crossing and recanalizing the CTO intraluminally in a controlled manner. Once the distal tip reaches and punctures the distal cap, the guidewire positioned inside the inner torque cable lumen is advanced into the distal true lumen, and the device is pulled out through the channel it formed, and through the accessories outside the body. The immediate result is a lumen gain and blood flow restoration through a channel formed by Santreva-ATK, revascularizing the previously ischemic distal zone, and allowing for a guidewire to be placed through this channel into the distal true lumen for further imaging and treatment.

Santreva-ATK has a working length of 135 cm and maximum crossing profile of 7.2 Fr (2.4 mm) with the centering system expanded.

Santreva-ATK is compatible with 6 Fr (of 0.070 inch Minimum ID) or larger guide catheters.

Santreva-ATK is also compatible with 5 Fr (of 0.070 inch Minimum ID) or larger guiding sheaths when not using a guide catheter.

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