Penumbra Launches STRIDE II Clinical Study to Further Evaluate Penumbra’s CAVT Technology for Lower Extremity Acute Limb Ischemia

Penumbra will begin recruitment for STRIDE II, a prospective, multicenter, global clinical study that will further evaluate the safety and effectiveness of Penumbra’s Lightning Bolt^™ Computer Assisted Vacuum Thrombectomy (CAVT^™) technology in patients with lower extremity acute limb ischemia (ALI).

ALI occurs when there is a sudden lack of blood flow to a limb, which is often caused by a blood clot. Although treatable, ALI is associated with high amputation rates and mortality if not treated promptly. STRIDE II will evaluate Penumbra’s latest Lightning Bolt CAVT technology — the most advanced and powerful arterial thrombectomy system on the market.

The Lightning Bolt portfolio, which includes Lightning Bolt 6x with Trax, Lightning Bolt 7, and Lightning Bolt 12, introduced a new method for removing blood clots, modulated aspiration. Penumbra’s Lightning^™ Intelligent Aspiration technology includes an advanced microprocessor algorithm designed to enhance the ability to rapidly remove blood clots in the arteries with minimal blood loss by fatiguing arterial thrombus of all morphology and sizes while increasing procedural efficiency in conditions such as acute limb ischemia (ALI) and visceral occlusions.

The first STRIDE study, an international, multi-center, prospective, single-arm study, in which 43.7% of cases involved the use of Lightning devices showed that the use of the Indigo Aspiration System in lower extremity ALI is safe and effective with excellent 30-day limb salvage rates (98.2%) and low mortality (3.4% at 30 days). Data suggests that traditional open vascular surgery to perform an embolectomy, by comparison, has an 83% 30-day limb salvage rate.¹

“The first STRIDE study showed that the Indigo® Aspiration System, including CAVT technology, was safe and effective for managing arterial thrombus, with high limb salvage rates, very low adverse events, low risk of bleeding, low mortality, all while being extremely efficient with an average 22 minutes of device time,” said Daniel Clair, MD, professor and chair of the Department of Vascular Surgery at Vanderbilt University Medical Center. “STRIDE II will test the latest technology while expanding the sample size and geographic scope of the investigation on a wider set of cases.”

The STRIDE II study will recruit up to 300 adult participants at up to 50 global sites. Study participants will be followed through six months after their procedure. This study will more than double that of the first STRIDE study and will roughly triple the number of sites reporting data. STRIDE II will also be more inclusive in terms of vessel locations, including iliac arteries and below.

For more information about the STRIDE II study, please visit ClinicalTrials.gov.

Important Safety Information

Additional information about Penumbra’s products can be located on Penumbra’s website at https://www.penumbrainc.com/products/peripheral-thrombectomy-cavt/. 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.

The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.

Copyright ©2025 Penumbra, Inc. All rights reserved. CAVT, Lightning Bolt, Lightning, and Indigo are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. All other trademarks are the property of their respective owners.

^{1 Maldonado, TS. Powell, A. Wendorff, H. et al. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024; 79:584-592.e5}