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Penumbra's Thrombectomy System Shows Safety, Clinical Benefit

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  • Penumbra Inc (NYSE: 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.

  • Price Action: PEN shares are down 1.70% at $283.11 during the market session on the last check Friday.

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