Seven New Data Sets Demonstrate Penumbra’s Computer Assisted Vacuum Thrombectomy (CAVT) Technology Is Safe, Fast and Effective, Improves Patient Outcomes, and Delivers Healthcare Resource Benefits

ALAMEDA, Calif., April 2, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's leading thrombectomy company, announced seven significant computer assisted vacuum thrombectomy (CAVT™) data presentations during the 2025 Society of Interventional Radiology (SIR) Annual Scientific Meeting. The data showed that CAVT as a frontline therapy for blood clots not only improved clinical and functional outcomes but can also help reduce overall healthcare costs. 

"With this growing body of evidence across several disease states, we are continuously demonstrating the wide-ranging impact CAVT can have as a frontline option on patient outcomes, quality of life and resource utilization in the healthcare system," said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. "This extensive research and innovation in clot management underscores our commitment to save lives, improve patient outcomes and positively impact healthcare economics."

STRIKE-PE Continued to Showcase CAVT's Speed, Safety and Simplicity in the Treatment of PE

All four presentations featuring interim results of STRIKE-PE demonstrated CAVT is a safe, fast and effective procedure for the treatment of pulmonary embolism (PE). Most notably, the subgroup analysis that evaluated the use of Lightning Flash™ only to treat PE showed:

• Significant reduction of right ventricle/left ventricle ratio by 27.8% and a decrease in mean pulmonary artery pressures by 24.5%
• Low overall major adverse event rate of under 1%
• Fast device time of 22.5 minutes (median)

Enrolling up to 1,500 patients, STRIKE-PE is one of the largest and most comprehensive PE trials with long-term functional and quality of life data. It was recognized at SIR for winning the JVIR Outstanding Clinical Study Award for the 2024 publication.

STRIDE Subset Analysis Showed High Limb Salvage Rate in LE-ALI with CAVT Use

A subset analysis of the STRIDE study demonstrated that when CAVT was used to address lower-extremity acute limb ischemia (LE-ALI) in both in-stent thrombosis and native-vessel thrombosis patients, the procedure was safe and effective with high target limb salvage rates at 30 days.

CAVT Decreased Healthcare Resource Utilization for LE-ALI and Lower Extremity Venous Thrombus

The results of the THRIVE study, a retrospective analysis of resource use and clinical outcomes with LE-ALI that compared CAVT use vs. embolectomy alone and vs. embolectomy with bypass, showed that CAVT was associated with:

• 99.1% limb salvage rate
• 26-46% shorter total hospital length of stay
• 46-75% higher rate of patients discharged home

Additionally, in a retrospective analysis evaluating CAVT use compared to anticoagulation alone to manage lower extremity venous thrombus, the results showed that CAVT was associated with:

• 17% shorter total hospital length of stay
• 40% higher rate of patients discharged home

These retrospective studies utilized the Vizient Clinical Data Base to identify patients with LE-ALI and lower extremity venous thrombus, respectively.

Separate from the SIR Annual Scientific Meeting, health economic data will be presented at other upcoming conferences showing hospital executives and leaders the significant positive economic benefits to the healthcare system of using CAVT in arterial and venous cases. 

For more information about the CAVT SIR presentations, please visit: www.penumbrainc.com/sir-2025.

About Penumbra

Penumbra, Inc., the world's leading thrombectomy company, is focused on developing the most innovative technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety and simplicity. By pioneering these innovations, we support healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life. For more information, visit www.penumbrainc.com and connect on Instagram, LinkedIn and X.

Important Safety Information

Additional information about Penumbra's products can be located on Penumbra's website at https://www.penumbrainc.com/providers. Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Please visit www.peninc.info/risk for the complete IFU Summary Statements.

The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.

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: 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 or other assets; 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, 2024 filed with the SEC on February 18, 2025. 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.

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SOURCE Penumbra, Inc.