Penumbra, Inc. Announces CHEETAH Clinical Study of Indigo? System CAT? RX Catheter
November 05, 2021 at 09:00 am EDT
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Penumbra, Inc. announced that the CHEETAH clinical study of its Indigo? System CAT? RX Catheter successfully met the primary endpoint and demonstrated high rates of blood clot removal, blood flow restoration and myocardial perfusion in conjunction with percutaneous coronary intervention (PCI) in patients with high thrombus burden. The CHEETAH clinical study enrolled 400 patients with high thrombus burden who were treated with continuous mechanical aspiration thrombectomy with CAT RX prior to PCI. Notable findings include: Significant reduction in Thrombolysis in Myocardial Infarction (TIMI) thrombus grade: 99.5% of patients achieved TIMI thrombus grade 0 after CAT RX and PCI. Improved TIMI flow grade: 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. Enhanced myocardial blush grade (MBG): 99.8% of patients achieved MBG 3 after CAT RX and PCI. No device-related serious adverse events occurred. 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.
Penumbra, Inc. is a healthcare company. The Company designs, develops, manufactures, and markets products and has a portfolio that addresses challenging medical conditions in markets with unmet need. It is focused on developing, manufacturing, and marketing products for use by specialist physicians and healthcare providers to drive improved clinical and health outcomes. It is focused on developing and building its portfolio of products, including its thrombectomy, embolization, access, and immersive healthcare technologies. Common conditions that the Company focuses on Pulmonary Embolism, Deep Vein Thrombosis, Peripheral Arterial Occlusion, Ischemic Stroke, Acute Coronary Syndrome, Clot associated with Arteriovenous Graft or Fistula, Aneurysm, and Hemorrhagic Stroke. The Company sells its products to healthcare providers primarily through its direct sales organization in the United States, Europe, Canada and Australia, as well as through distributors in select international markets.