Penumbra Receives FDA Clearance for RED 62 Reperfusion Catheter, Enabling Physicians to Address Broad Range of Stroke Patients
- Now available in the U.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
- First catheter of new RED series expands the company’s extensive portfolio of innovative stroke products
ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc., (NYSE: PEN), a global healthcare company focused on innovative therapies, today 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.
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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. (Photo: Business Wire)
“In my initial experience with RED 62, I am impressed by how responsive the catheter is as I navigate through the intricate vessels of the brain,” said Kurt Reuland, M.D., interventional neuroradiologist at CHRISTUS Trinity Mother Frances Health System in Tyler, TX. “The performance and length of RED 62 enable me to address a broader group of patients using aspiration thrombectomy to remove blood clots and improve my patients’ health outcomes.”
The RED 62 is engineered with the latest innovations in tracking and aspiration technology to address large vessel occlusions located in more challenging distal vessel anatomy while maximizing powerful aspiration to remove blood clots. It has a low diameter profile and extended length to reach the target vessel.
“With the continued success of aspiration thrombectomy, physicians asked us to address navigation in more challenging distal vessels. RED 62 builds on our previous design generations, continuing our efforts to maximize both trackability and aspiration power,” said Adam Elsesser, president and chief executive officer of Penumbra. “This is the first catheter in the RED series, which will provide physicians with the broadest portfolio of aspiration thrombectomy solutions for stroke management while also focusing on reducing overall healthcare costs.”
About the Penumbra System
The fully integrated Penumbra System is designed specifically for mechanical thrombectomy. The Penumbra System enables physicians to use aspiration, which acts like a minimally invasive “vacuum” inside the artery, to remove stroke-causing blood clots from the brain safely and effectively. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The Penumbra System includes Reperfusion Catheters, 3D Revascularization Device™, the Penumbra ENGINE aspiration source and other accessories.
Important Safety Information
Additional information about Penumbra’s products can be located on Penumbra’s website at http://www.penumbrainc.com/healthcare-professionals. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. Risk information can be found here.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra, the Penumbra P logo, Penumbra ENGINE, RED, and 3D Revascularization Device are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn.
Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on February 23, 2021. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.
Source: Penumbra, Inc.