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400 Patients

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25 Sites

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High Thrombus Burden in ACS


Demonstrate the safety and performance of the Indigo® Aspiration System using the CAT RX aspiration catheter in a population presenting with acute high thrombus burden coronary vessel occlusion who are referred for Percutaneous Coronary Intervention (PCI)

Read more in Circulation: Cardiovascular Interventions

Precaution: The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention.

Published in Circ CI1

Primary Composite Endpoint Met

Safe in High-Risk Patient Population


Freedom from MACE at 30 daysa


Device related SAEs (including strokeb)

Successful Thrombus Removal

High Rates of Flow Achieved


TIMI 2-3 flow post-CAT RX


TIMI 3 flow at final angiography

Low Distal Embolization Rate


Improved Myocardial Perfusion

Achieving high myocardial blush grade (MBG 3) during PCI has been associated with improved outcomes in acute MI3

of patients with MBG 3 at final angiography

Power aspiration with CAT RX is safe for removal of high thrombus burden with low rates of distal embolization and improved myocardial perfusion

a. Composite of 30 day cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure.
b. There were 3 (.75%) incidence of non-device related strokes as IMR adjudicated.
1. Mathews SJ, et al. Sustained mechanical aspiration thrombectomy for high thrombus burden coronary vessel occlusion: the multicenter CHEETAH Study. Circ Cardiovasc Interv. 2023 Feb;16(2):e012433. doi: 10.1161/CIRCINTERVENTIONS.122.012433.
2. Henriques JPS, Zijlstra F, Ottervanger JP, et al. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002 Jul;23(14):1112–1117. doi: 10.1053/euhj.2001.3035.
3. Rehman A, Malik J, Javed N, Iftikhar I, Sharif H. Myocardial blush grade: a determinant of left ventricular ejection fraction and adverse outcomes in STEMI. Scott Med J. 2021 Feb;66(1):34–39. doi: 10.1177/0036933020941260.
The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.

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