Penumbra Receives FDA Clearance for RED 62 Reperfusion Catheter, Enabling Physicians to Address Broad Range of Stroke Patients
June 23, 2021 at 09:00 am EDT
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Penumbra, Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial availability of the RED™ 62 Reperfusion Catheter, the latest addition to the company’s comprehensive Penumbra System®. RED 62 is designed to navigate complex distal vessel anatomy and deliver powerful aspiration, together with Penumbra ENGINE®, for the removal of blood clots in acute ischemic stroke patients with large vessel occlusions. Now available in the U.S., Penumbra’s RED™ 62 is engineered with optimized trackability to help navigate the complex distal vessel anatomy in the brain and deliver powerful aspiration for the removal of blood clots.
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.