Firstline use of the Indigo® Aspiration System for Acute Limb Ischemia patients resulted in low 30-day amputation rates, low peri-procedural complications, and high rates of technical success.

Prospective, Single-Arm

119 Patients

16 International Sites

Lower Extremity Acute Limb Ischemia (LE-ALI)

  • To evaluate real-world safety, performance, and Quality of Life (QoL) outcomes in Computer Assisted Vacuum Thrombectomy (CAVT) in a patient population with acute Pulmonary Embolism (PE)

  • In the STRIDE study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for LE-ALI patients, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few peri-procedural complications.

Now published in the Journal of Vascular Surgery

Clinical Trials

30-day Results:

98.2% Target limb salvage rate at 30 days post procedure

3.4% Mortality at 30 days

22 min Median Indigo Aspiration Time

0.8% Device-related SAE

Historical Surgical Outcomes & STRIDE Study Data

Outcome Open Surgery STRIDE1,a
Target Limb Salvage at 30 days 83.1%2,b 98.2% (109/111)
Patency at 30 days 78.6%3 89.4% (101/113)
Mortality at 30 days 13.2%4 3.4% (4/119)
Major bleedingc 21.0%5 4.2% (5/119)

a. STRIDE study was not a randomized or head-to head study; data cannot be directly compared. Please refer to specific publications to review source for detailed patient and data collection methods for open surgical revascularization.
b. Composite limb salvage rate at 30 days calculated and data on file at Penumbra, Inc.
c. Major bleeding definitions may vary across studies. Please refer to specific publications for details.

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(3):584–592.e5. doi:10.1016/j.jvs.2023.10.062.
2. Veenstra EB, van der Laan MJ. Zeebregts CJ, et al. A systematic review and meta-analysis of endovascular and surgical revascularization techniques in acute limb ischemia. J Vasc Surg. 2020 Feb;71(2):654-668.e3. doi:10.1016/j.jvs.2019.05.031.
3. Grip O. Wanhainen A, Michaëlsson K, Lindhagen L, Björc M. Open or endovascular revascularization in the treatment of acute lower limb ischaemia. Br J Surg. 2018 Nov;105(12):1598-1606. doi:10.1002/bjs.10954.
4. Taha AG, Byrne RM, Avgerinos ED, et al. Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia. J Vasc Surg. 2015 Jan;61(1):147-157. doi:10.1016/j.jvs.2014.06.109.
5. Kolte D, Kennedy KF, Shishehbor MH, et al. Endovascular versus surgical revascularization for acute limb ischemia: a propensity-score matched analysis. Circ Cardiovasc Interv. 2020;13(1):e008150.

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.


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