Penumbra Announces European Launch of RED® Reperfusion Catheters for Stroke Care

Rhea-AI Summary

Penumbra, Inc. (NYSE: PEN) announced the European launch of its RED® Reperfusion Catheters following CE Mark approval. These catheters, part of the Penumbra System®, are designed for mechanical thrombectomy in acute ischemic stroke patients. Initial data from the INSIGHT Registry revealed a 68.9% first-pass revascularization success rate across all clot types. The RED catheters feature advanced trackability and aspiration technologies, enhancing their effectiveness. This expansion aims to improve treatment options for stroke patients in Europe, enabling faster and more efficient clot removal.

Positive

• Secured CE Mark for RED® Reperfusion Catheters, enabling commercial availability in Europe.
• Initial data showed a 68.9% first-pass revascularization success rate for all clot types.
• Enhanced trackability and aspiration efficiency of RED catheters could significantly improve patient outcomes.

Negative

• None.

• Physicians in Europe now have access to Penumbra’s latest stroke technology for mechanical thrombectomy
• RED^® reperfusion catheters are designed with optimized trackability and aspiration efficiency to help navigate the complex anatomy of the brain and deliver powerful aspiration for the removal of blood clots
• Initial INSIGHT Registry data presented at WFITN demonstrated RED catheters were highly effective in removing all clot types with an impressive 68.9% mTICI > 2b-3 overall first pass effect rate

ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced that its RED^® Reperfusion Catheters have secured CE Mark (Conformité Européenne) and are now commercially available in Europe. The catheters are part of the company’s Penumbra System^®, which is a fully integrated mechanical aspiration thrombectomy system designed to restore blood flow in acute ischemic stroke (AIS) patients.

Penumbra’s RED® Reperfusion Catheters are now commercially available in Europe. The catheters are part of the company’s Penumbra System®, which is a fully integrated mechanical aspiration thrombectomy system designed to restore blood flow in acute ischemic stroke (AIS) patients. (Graphic: Penumbra)

“When addressing stroke, our goal is to remove the blood clot as quickly as possible for patients to have the best outcome,” said Saleh Lamin, M.D., neurointerventionalist, Queen Elizabeth Hospital, Birmingham, UK. “With RED catheters, we will be able to get up to the clot quickly and efficiently remove it, most of the time within a single pass. Restoring blood flow promptly is key as it is associated with less damage to the brain and better outcomes.”

The RED family of catheters is engineered with the latest technology in trackability and aspiration to address a wide range of large vessel occlusions via mechanical aspiration thrombectomy. The RED catheters feature REDglide™ technology, which enhances the trackability of the catheters as they navigate the challenging vessel anatomy of the brain while also maximizing aspiration efficiency to remove blood clots. Additionally, the RED catheters have a full-length PTFE liner designed to maintain their true lumen size under powerful vacuum.

“Penumbra’s commitment to advancing technology allows us to have one of the most expansive aspiration stroke portfolios on the market, enabling physicians to have the latest innovations with the most options to provide the best care to their patients,” said Joan Kristensen, vice president and head of the Europe, Middle East and Africa region for Penumbra, Inc. “With enhanced trackability and powerful aspiration, initial data has shown that Penumbra’s RED catheters can restore blood flow quickly across all clot types, which would potentially have a significant impact on patient outcomes here in Europe.”

Initial INSIGHT Registry data presented in August at the World Federation of Interventional and Therapeutic Neuroradiology (WFITN) showed Penumbra’s RED^® reperfusion catheters were successful in removing all clot types with a significant first pass rate. The data from 161 AIS patients showed 68.9% successful first-pass revascularization (mTICI≥2b-3), and 97% successful revascularization after final angiogram through site reported findings. Final mTICI≥2b-3 scores were reported in 98.1% of patients with firm-red clots and in 100% of patients with other clot types.

“Expanding access to our leading RED catheters in Europe enhances Penumbra’s ability to support more physicians and patients around the world,” said Sandra Lesenfants, president of interventional at Penumbra, Inc. “As we continue to pioneer interventional technology, our commitment is to improve care so patients, especially those with serious conditions such as stroke, can return home quickly and live full lives.”

About Penumbra

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 supports healthcare providers, hospitals and clinics in more than 100 countries. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn.

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.

Forward-Looking Statements

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; potential adverse regulatory actions; and the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 22, 2022. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220907005565/en/

Jennifer Heth

Penumbra, Inc

jheth@penumbrainc.com

510-995-9791

Joni Ramirez

Merryman Communications

joni@merrymancommunications.com

323.532.0746

Source: Penumbra, Inc.

FAQ

What is the significance of Penumbra's RED® Reperfusion Catheters in stroke treatment?

Penumbra's RED® Reperfusion Catheters are designed to enhance mechanical thrombectomy for stroke patients, promising quicker and more effective removal of blood clots.

How effective are the RED® Reperfusion Catheters according to initial data?

Initial data from the INSIGHT Registry indicated a 68.9% first-pass revascularization success rate for all types of clots.

When did Penumbra launch its RED® Catheters in Europe?

Penumbra announced the launch of its RED® Reperfusion Catheters in Europe following the receipt of CE Mark approval.

What are the performance features of RED® Reperfusion Catheters?

The RED® Catheters are engineered for optimized trackability and aspiration efficiency, crucial for navigating brain anatomy and removing clots.

What is Penumbra's stock symbol?

Penumbra's stock is traded under the symbol 'PEN' on the New York Stock Exchange.