Penumbra’s Indigo Aspiration System Studied for Acute Limb Ischemia in STRIDE

May 3, 2023—Penumbra, Inc. announced that new data from the STRIDE study shows that the use of the company’s Indigo aspiration system in lower-extremity acute limb ischemia (ALI) is safe and effective with excellent 30-day limb salvage rates and low mortality. Indigo is a minimally invasive continuous aspiration device that can be used to quickly remove emboli and thrombi from vessels of the peripheral arterial and venous systems.

According to the company, STRIDE is an international, multicenter, prospective, single-arm study using mechanical thrombectomy with the Indigo aspiration system as frontline treatment. The study enrolled 119 patients from 16 centers across the United States and Europe.

The study’s primary endpoint of target limb salvage was achieved in 98.2% of patients. The Indigo system was able to achieve these high rates of limb salvage and low rate of mortality in just 22 minutes of device time, noted the company.

The fully enrolled, 30-day STRIDE data were presented at CX 2023, the Charing Cross International Symposium held April 25-27 in London, United Kingdom.

The national Principal Investigator of the STRIDE study is Thomas Maldonado, MD, Professor of Surgery at the New York University of Langone Health in New York, New York.

“ALI is a serious condition that requires urgent treatment, and amputation is often considered without hesitation,” commented Dr. Maldonado. “The 30-day STRIDE data is encouraging as the trial showed that we can save a patient’s limb more than 98% of time.”

Dr. Maldonado continued, “When you look at traditional open vascular surgery to perform an embolectomy, data suggests an 83% 30-day limb salvage rate. As we continue to evaluate mechanical thrombectomy as frontline treatment, this clinical evidence, and the addition of new technology such as Penumbra’s Lightning Bolt 7, could represent a new frontier in helping patients with ALI.”

STRIDE investigator Sean Lyden, MD, stated, “The STRIDE study showed that this technology was safe and effective for treating arterial thrombus, but also confirms that swift removal of these blood clots can also improve limb salvage and mortality rates at 30-days. In addition to the endpoint success, the STRIDE study enrolled a diverse patient population with more than 46% of the patients enrolled being female, an often-underrepresented population in arterial clinical studies.” Dr. Lyden is Chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute in Cleveland, Ohio.