New Data Show Penumbra’s Computer Assisted Vacuum Thrombectomy (CAVT) Used in a Single-Session Without Overnight Thrombolytics Is Safe and Effective for Patients with LE-ALI

During this week’s SIR Annual Meeting, newly presented data from a sub-group analysis of the STRIDE study showed that Penumbra’s Indigo^® Aspiration System used in a single-session without the need for overnight tissue plasminogen activator (tPA) is safe and effective for patients with lower extremity acute limb ischemia (LE-ALI).

“Although the use of tPA following aspiration thrombectomy with Indigo System was not limited during the STRIDE study, the majority of patients did not receive it and still experienced excellent outcomes,” said STRIDE investigator Jayer Chung, M.D., Baylor College of Medicine, TX.
“These findings demonstrate that the use of aspiration mechanical thrombectomy, without overnight tPA, yields high procedural success, low complication rates, and high target limb salvage rates in LE-ALI.”

Although widely used, there are many complications associated with tPA and other clot-busting drugs. In the case of the overnight lytic group, tPA was also associated with an increased need for intensive care unit (ICU) monitoring as shown by the higher median length of ICU stay among those patients.

“The high risk of associated major bleeding is a notable limitation of thrombolytics as an intervention across many disease states, and LE-ALI is no exception,” said Thomas Maldonado, M.D., national principal investigator of the STRIDE study, and professor of surgery at the New York University of Langone Health. “The data show that aspiration mechanical thrombectomy is a safe and effective minimally invasive procedure, which may offer an option to eliminate thrombolytic use for some patients.”

STRIDE is an international, prospective, single-arm, multicenter, observational study of patients with LE-ALI and using Indigo Aspiration System as a frontline intervention. The latest findings include:

• No significant differences were detected between patients who received overnight tPA and those who did not for target limb salvage rate at 30 days, patency at 30 days and 30-day mortality.
• ICU resource utilization was significantly lower in single-session Indigo patients.

ALI, a sudden lack of blood flow to a limb, is associated with a high risk of amputation and death. Studies have shown that ALI patients treated with catheter-directed thrombolysis often risk further vascular complications, such as major bleeding.¹

Important Safety Information

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

1. Maldonado T, Powell A, et al. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024. 79(3):584-592.
DOI:https://doi.org/10.1016/j.jvs.2023.10.062