Lightning Bolt® 6X with TraXTM Case Study: Revascularization of Tibioperoneal Artery with Computer Assisted Vacuum Thrombectomy (CAVTTM)

January 27, 2025
Image of Lightning Bolt 6x with Trax

With its ability to address distal thrombus while maintaining 6 F access, Lightning Bolt 6X with TraX significantly expands the impact of Penumbra’s Computer Assisted Vacuum Thrombectomy (CAVT) technology to a broader range of patients.

Lightning Bolt 6X with TraX delivers the same powerful aspiration technology as Lightning Bolt 7, but Lightning Bolt 6X with TraX is designed to maintain 6 F access and deliver vacuum to smaller vessels. The CATTM6X Catheter features advanced coil-winding designed for superior trackability and an enhanced hydrophilic coating designed for smoother navigation. It also introduces Penumbra’s first arterial-designed dilator, TraX, to help provide precise vessel selection with 99 percent ledge reduction for continuous navigation to the target lesion.

Lightning Bolt 6X with TraX also features Bolt Mode, which rapidly modulates aspiration between continuous vacuum and no vacuum for faster thrombus removal and flow restoration.*

An illustrative case of Lightning Bolt 6X with TraX comes from Indiana University Health in Indianapolis.

Case Study
A 72-year-old male presented to the hospital with symptoms of an arterial occlusion after bilateral cutdowns post-FEVAR. Distal pulses were confirmed prior to abdominal aortic aneurysm (AAA) intervention and post-procedure pulses were undetectable in the left dorsalis pedis artery (DPA).

Intervention
Initial angiograms were taken, and clot was visible in the left anterior tibial and tibioperoneal arteries. Access was obtained with a short 6-F sheath introduced into the left common femoral artery.

With one pass of Lightning Bolt 6X with TraX, acute thrombus was successfully removed with insignificant blood loss. Recorded device time was under a minute. Final angiograms showed successful removal of the thrombus and the left DPA pulse indicated distal flow. The patient was kept overnight due to standard FEVAR AAA graft protocol and discharged the next day.

Initial angiogram of occlusion in the anterior tibial and tibioperoneal arteries Initial angiogram of occlusion in the anterior tibial and tibioperoneal arteries

PRE: Initial angiogram of occlusion in the anterior tibial and tibioperoneal arteries

Post-thrombectomy angiogram of left anterior tibial and tibioperoneal Post-thrombectomy angiogram of left anterior tibial and tibioperoneal

POST: Post-thrombectomy angiogram of left anterior tibial and tibioperoneal

Conclusion
The procedure was the physicians’ first experience with Lightning Bolt 6X with TraX. They reported that they were pleased with the device’s ease of use and the positive results of CAVT. Furthermore, they shared that Lightning Bolt 6X with TraX features made for easy navigation through tough anatomy and facilitated their ability to detect and remove thrombus quickly. The use of CAVT in this difficult situation likely saved hours of intervention and maintained flow to the distal arterial vasculature.

*Bench top testing comparing aspiration times of Lightning Bolt 12 vs. Lightning® 12 and Lightning Bolt 6X with TraX vs. CAT 6 and SeparatorTM 6. Tests performed and data on file at Penumbra, Inc. Bench test results may not be indicative of clinical performance.

Important Safety Information
Additional information about Penumbra’s CAVT products can be located on Penumbra’s website at https://www.penumbrainc.com/products/peripheral-thrombectomy-indigo-system/. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Risk information can be found at peninc.info/risk.

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