Penumbra Commences Postmarket CHEETAH Study of Indigo System With CAT RX Aspiration Catheter

October 10, 2019—Penumbra, Inc. announced enrollment of the first patient in the prospective, postmarket CHEETAH study evaluating the safety and performance of the company’s Indigo system with CAT RX continuous aspiration thrombectomy catheter for mechanical thrombectomy in the coronary vessels.

Introduced in 2018 as part of the Indigo aspiration system, the Indigo CAT RX aspiration catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The device uses mechanical power aspiration to remove thrombus in the coronaries.

The multicenter CHEETAH study will enroll up to 400 patients presenting with coronary thrombus who are referred for percutaneous coronary intervention at up to 25 United States centers.

The primary study endpoint is a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure within 30 days. Secondary endpoints include final thrombolysis in myocardial infarction (TIMI) flow grade, final TIMI thrombus grade, and safety assessments at 6 months.

A team led by Larry J. Diaz-Sandoval, MD, enrolled the first patient in the CHEETAH study. Dr. Diaz-Sandoval is Director of Endovascular Research and Interventions at Metro Health-University of Michigan Health Hospital in Grand Rapids, Michigan. He commented in the company’s announcement, “This important study will help inform us of the potential impact of clot removal in patients with high thrombus burden.”

The study’s National Principal Investigator, S. Jay Mathews, MD, stated, “Penumbra has adapted over 10 years of neurothrombectomy experience to address the limitations of traditional manual aspiration for the coronaries by development of the Indigo system CAT RX device. This significant upgrade in innovation from syringe-based aspiration to mechanical power aspiration coupled with highly trackable catheter technology has enabled us to improve our door to reperfusion times and thereby to improve patient care.” Dr. Mathews is Director of the Cardiac Catheterization Laboratory at Manatee Memorial Hospital in Bradenton, Florida.

Jasvindar Singh, MD, added, “Just like the IMS-III trial for ischemic stroke, the TOTAL trial highlighted that new therapies are needed to improve the outcomes of these patients with high thrombus burden. The CHEETAH study is the first step toward making coronary mechanical thrombectomy standard of care for high thrombus burden patients. We expect this study to refine our technique of thrombus aspiration and better understand the utilization of CAT RX for patients with high thrombus burden.” Dr. Singh is Associate Professor of Medicine and Director of the Cardiac Catheterization Laboratory at Barnes Jewish Hospital/Washington University School of Medicine in St. Louis, Missouri.