Penumbra, Inc., tells us it has seen enrollment of the first patient into a prospective, multi-center U.S. study to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels.
Originally introduced in 2014, Penumbra’s Indigo System is a continuous aspiration mechanical thrombectomy system designed to remove clot from arteries and veins in the peripheral vasculature. In 2018, as part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters (pictured) and Indigo Separator™ 4 were introduced, indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
The Indigo System CAT RX device uses mechanical power aspiration to remove thrombus in the coronaries. The post-market, prospective CHEETAH study will enroll up to 400 patients presenting with coronary thrombus who are referred for percutaneous coronary intervention (PCI) at up to 25 U.S. centers. The primary study endpoint is a composition of cardiovascular (CV) death, recurrent myocardial infarction (MI), cardiogenic shock or new or worsening New York Heart Association (NYHA) Class IV heart failure within 30 days. Secondary endpoints include final TIMI flow grade, final TIMI thrombus grade, and safety assessments at six months.
“This important study will help inform us of the potential impact of clot removal in patients with high thrombus burden,” said Larry J. Diaz-Sandoval, M.D., director, endovascular research and interventions, Metro Health-University of Michigan Health Hospital, Grand Rapids, Michigan, whose team enrolled the first patient in the CHEETAH study.
Source: Penumbra, Inc.