Dubbed the STRIDE Study, the trial examined the use of the company’s Penumbra’s Indigo System for patients with lower extremity acute limb ischaemia. Credit: Shutterstock / Casa nayafana

Californian device company Penumbra has announced one-year data from a trial that found using the Indigo Aspiration System to carry out a mechanical thrombectomy saw an 88.5% success rate at salvaging limbs.

Dubbed the STRIDE Study, the trial examined the use of the company’s Penumbra’s Indigo System for patients with lower extremity acute limb ischaemia (LE-ALI), finding the device safe and effective whilst at the same time improving quality of life.

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The multicenter, prospective, single-arm, observational study enrolled 119 patients across 16 sites in the United States and Europe and saw a relatively low 12% mortality rate after one year, achieving its primary endpoint of demonstrating safety and effectiveness when it comes to limb salvage.

Thomas Maldonado, principal investigator of the STRIDE study, said: “The latest STRIDE data continue to demonstrate the use of Penumbra’s Indigo® Aspiration System to address LE-ALI results in excellent outcomes, including high target limb salvage rates and quality of life.

“The data is promising in that it underscores the significant benefits of continuous aspiration to remove thrombus and should be considered a frontline treatment for LE-ALI.”

Acute limb ischaemia comes in the form of a sudden lack of blood flow to a particular limb, usually associated with a high rate of mortality and often requiring an immediate mechanical thrombectomy to save the limb. Penumbra claims that the Indigo System can complete the procedure in as little as 22 minutes.

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Now, results from Penumbra’s STRIDE trial have been published in the Journal of Vascular Surgery and were presented at the Vascular Annual Meeting (VAM) in Chicago. In April 2024 the company saw its Flash 2.0, a next-generation computer-assisted vacuum thrombectomy (CAVT) system receive the green light from the US Food and Drug Administration (FDA).

A report on GlobalData’s Medical Intelligence Center details how the number of neurovascular thrombectomy procedures in the US is forecast to reach 153,691 by 2030.

Elsewhere in the field of thrombectomy devices, competitor Ceretrieve  announced positive study results for its aspiration catheter demonstrating clot removal and completely restoring blood flow in a single pass.