Penumbra Indigo Aspiration System Evaluated in 1-Year STRIDE Data

August 20, 2024—Penumbra, Inc. announced 1-year limb salvage and quality-of-life data from the STRIDE study of the company’s Indigo aspiration system for treatment of patients with lower extremity acute limb ischemia (LE-ALI). The company stated the study showed that frontline use of Indigo to treat LE-ALI is safe and effective.

According to Penumbra, STRIDE was designed to assess the safety and efficacy of mechanical thrombectomy using the Indigo system in patients with LE-ALI. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire was assessed at baseline and follow-up through 365 days.

The multicenter, prospective, single-arm, observational study enrolled 119 patients across 16 sites in the United States and Europe. The study completed follow-up in October 2023.

As summarized in Penumbra’s press release, the 1-year outcomes include an 88.5% target limb salvage rate and a 12% mortality rate at 365 days. From baseline to 1-year follow-up, there was an overall improvement in quality of life, as measured by the VascuQoL-6 questionnaire.

The 1-year findings were published by Thomas S. Maldonado, MD, et al online in Journal of Vascular Surgery and presented at VAM24, the Society for Vascular Surgery’s 2024 Vascular Annual Meeting held June 19-22 in Chicago, Illinois.

The company stated that the 1-year results build on evidence from the 30-day STRIDE data in which the primary endpoint (target limb salvage) was achieved in 98% of patients. The Indigo system was able to achieve these high rates of limb salvage and low rates of mortality with a median device time of 22 minutes, noted Penumbra.

In March 2024, the 30-day results were published by Thomas S. Maldonado, MD, et al in Journal of Vascular Surgery (2024;79:584-592).

Dr. Maldonado is Professor of Surgery at NYU Langone Health of New York University in New York, New York, and National Principal Investigator of the STRIDE study.

“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,” commented Dr. Maldonado in the company’s press release. “The data are promising in that they underscore the significant benefits of continuous aspiration to remove thrombus and should be considered a frontline treatment for LE-ALI.”

Penumbra advised that STRIDE was not a randomized or head-to-head study; however, the company outlined a comparison of the STRIDE data versus control data of historical surgical outcomes from various studies. The comparison showed 30-day target limb salvage of 98.2% in STRIDE versus 83.1% in historical surgical data and 365-day target limb salvage of 88.5% versus 77.3%. Additionally, patency at 30 days was 89.4% versus 78.6%; mortality at 30 days was 3.4% versus 13.2%; mortality at 365 days was 12% versus 33.8%; and major bleeding was 4.2% in STRIDE versus 21% in the surgical control, reported Penumbra.