Penumbra, Inc. Announces Completion of THUNDER IDE Study Enrollment for Acute Ischemic Stroke
Penumbra, Inc. (NYSE: PEN), a leading thrombectomy company, has completed enrollment for its THUNDER clinical study evaluating the safety and efficacy of its latest computer assisted vacuum thrombectomy (CAVT™) technology for acute ischemic stroke patients.
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Penumbra, Inc. (NYSE: PEN), a leading thrombectomy company, has completed enrollment for its THUNDER clinical study evaluating the safety and efficacy of its latest computer assisted vacuum thrombectomy (CAVT™) technology for acute ischemic stroke patients. The study focuses on the Penumbra System™ with Thunderbolt™ Aspiration Tubing for removing blood clots in the brain.
The Thunderbolt technology uses an advanced CAVT software algorithm to generate modulated aspiration, aiming to reduce friction and facilitate faster, more complete clot removal. The THUNDER study (NCT05437055) is a multi-center, single-arm study involving patients with acute ischemic stroke due to intracranial large vessel occlusion (LVO) eligible for mechanical thrombectomy. The primary efficacy endpoint is the revascularization of the occluded target vessel immediately post-procedure.
Positive
- Completion of enrollment in the THUNDER clinical study for acute ischemic stroke
- Evaluation of advanced CAVT technology for potentially improved blood clot removal
- Multi-center study design to assess efficacy and safety of the Penumbra System with Thunderbolt Aspiration Tubing
Negative
- None.
Details
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"This critical milestone brings us another step closer to providing physicians with the latest technology for stroke management," said Adam Elsesser, president and chief executive officer of Penumbra. "The THUNDER study will provide the data set needed to evaluate Penumbra's Thunderbolt technology and I am optimistic that we are at the dawn of a new era in stroke treatment."
Penumbra System with Thunderbolt Aspiration Tubing uses an advanced CAVT software algorithm to generate proprietary modulated aspiration, reducing friction between the clot and reperfusion catheter and facilitating a more rapid and complete removal of blood clots in the brain. Thunderbolt Aspiration Tubing has been designed for use with Penumbra ENGINE™ and RED™ reperfusion catheters.
The THUNDER study (NCT05437055) is a multi-center, single-arm study evaluating patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy. The primary efficacy endpoint includes revascularization of the occluded target vessel at immediate post-procedure.
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. Its 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, Penumbra supports 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. 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 at http://www.peninc.info/risk.
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, 2023 filed with the SEC on February 22, 2024. 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.
Contact | |
Jennifer Heth | Parinaz Farzin |
Penumbra, Inc. | Merryman Communications |
510-995-9791 | 310.600.6746 |
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SOURCE Penumbra, Inc.
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