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New STRIDE Data on Aspiration Thrombectomy Show No Sex Differences in Target Limb Salvage Rates in Lower Extremity ALI Patients

January 29, 2024
Logo for Stride Study that has veins in a leg with text "STRIDE STUDY"

Penumbra’s Indigo® Aspiration System provides a safe and effective intervention for lower extremity-acute limb ischemia (LE-ALI) for both females and males, according to new data from a sub-analysis of the STRIDE study. Data were presented last week at the International Symposium on Endovascular Therapy’s (ISET) annual meeting in Miami Beach, Florida.

Associated with a high-risk of limb loss and death, ALI occurs when there is a sudden interruption of blood flow through blood vessels of the arms or legs. In most cases, flow is blocked by blood clot. The analysis showed that aspiration thrombectomy for LE-ALI in both sexes resulted in high target limb salvage rates (98.0% female, 98.4% male) and low complication rates. Limb salvage rates are higher than those reported in literature1-4 for open surgery.

“The findings, indicating comparable revascularization outcomes between females and males, even in the presence of more complicated clinical presentation among females, underscore the considerable advantages of employing Indigo Aspiration System as a first line arterial intervention,” said Alex Powell, M.D., who presented the data and is medical director of Interventional Radiology, Miami Cardiac & Vascular Institute. “The STRIDE study offers valuable opportunity to scrutinize sex-based differences in the data, given that almost half of the study participants were female – a demographic frequently underrepresented in arterial clinical studies.”

STRIDE is an international, prospective, single-arm, multicenter, observational study that enrolled 119 patients with LE-ALI and used Indigo Aspiration System as a frontline intervention. The primary endpoint of the study, target limb salvage, was achieved in 98.2% of patients. The Indigo System was able to achieve this high rate of limb salvage and low rate of mortality (3.4%) in just 22 (median) minutes of device time. Penumbra’s Indigo Aspiration System is a minimally invasive continuous aspiration device that is designed to quickly remove emboli and thrombi from vessels of the peripheral arterial and venous systems.

“This latest STRIDE data confirmed that Penumbra’s Indigo Aspiration System when used as a first line intervention for acute limb ischemia has equally excellent results for both male and female genders,” said Dr. James Benenati, M.D., FSIR, chief medical officer at Penumbra. “Penumbra’s thrombectomy devices, including our CAVT (computer assisted vacuum thrombectomy), are designed to facilitate speed, safety and simplicity while efficiently removing thrombus. This technology has the potential to decrease amputation rates by improving limb salvage in patients with acute limb threatening ischemia. This is extremely important in women because other methods of therapy demonstrate poorer outcomes and more complications in this group as opposed to the excellent outcomes seen in our trial with CAVT and Indigo devices.”

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.

References
1. Veenstra EB, van der Laan MJ, Zeebregts CJ, de Heide EJ, Kater M, Bokkers RPH, 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.
2. Grip O, Wanhainen A, Michaëlsson K, Lindhagen L, Björck 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.
3. 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):147–54. doi:10.1016/j.jvs.2014.06.109.
4. Kolte D, Kennedy KF, Shishehbor MH, Mamdani ST, Stangenberg L, Hyder ON, et al. Endovascular versus surgical revascularization for acute limb ischemia: a propensity-score matched analysis. Circ Cardiovasc Interv. 2020;13(1):e008150.

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