Penumbra's Thrombectomy System Shows Safety, Clinical Benefit

Penumbra Inc PEN announced that the CHEETAH clinical study of its Indigo System CAT RX Catheter met the primary endpoint.
As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated to remove fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
The trial demonstrated high rates of blood clot removal, blood flow restoration, and myocardial perfusion in conjunction with percutaneous coronary intervention (PCI) in patients with a high thrombus burden.
The results were presented at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference.
The CHEETAH clinical study enrolled 400 patients treated with continuous mechanical aspiration thrombectomy with CAT RX before PCI.
99.5% of patients achieved significantly reduced thrombolysis in Myocardial Infarction (TIMI) thrombus after CAT RX and PCI.
97.5% of patients’ TIMI flow grade 3 after CAT RX and PCI. TIMI 2-3 increased significantly from 16.6% at baseline to 85% after CAT RX alone.
99.8% of patients achieved Enhanced myocardial blush grade (MBG) 3 after CAT RX and PCI.
No device-related serious adverse events occurred.
In the study, the CAT RX procedure took about 69 seconds to complete.
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