Study supports use of aspiration as frontline thrombectomy therapy for acute ischemic stroke
HOUSTON – Feb. 22, 2017 – Penumbra, Inc. (NYSE: PEN), a global interventional therapies company, today announced the presentation of the results of the ASTER Trial, the first independent, prospective, randomized trial comparing the use of Penumbra's aspiration system to stent retriever, in the opening plenary session at the International Stroke Conference in Houston, Texas. The ASTER Trial provides additional evidence of Penumbra's aspiration system as an effective frontline thrombectomy approach for acute ischemic stroke as part of the ADAPT (A Direct Aspiration, First Pass Technique) technique.
"The ASTER study provides evidence that starting with Penumbra aspiration first as part of the ADAPT technique is similar to the stent retriever technique," said Michel Piotin, MD, principal investigator and interventional neuroradiologist at Rothschild Fondation Hospital in Paris. "The ADAPT technique offers the possibility to easily add a stent retriever following Penumbra aspiration if needed, leading to time savings."
The data showed that the ADAPT technique compared favorably: 85.4 percent of patients treated with Penumbra's aspiration system achieved the primary endpoint of TICI 2b/3 at the end of the procedure compared with 83.1 percent of patients treated with stent retrievers (p=0.53). Moreover, 63.0 percent of patients treated with Penumbra's aspiration system achieved the secondary endpoint of TICI 2b/3 after frontline treatment compared to 67.7 percent with stent retrievers (p=0.33).
"The ASTER Trial shows no significant difference in revascularization rate and safety using either thrombectomy technique – Penumbra aspiration and stent retrievers – for acute ischemic stroke patients with large vessel occlusions," said Bertrand Lapergue, MD, PhD, Division of Neurology, Stroke Center, Foch Hospital, University Versailles Saint-Quentin en Yvelines (France) and scientific coordinator for the study. "The broad eligibility criteria achieved in the ASTER Trial make the results generalizable to the majority of stroke patients with large vessel occlusions."
Secondary safety endpoints presented, including embolization in new territory (ENT) and symptomatic intracranial hemorrhage (sICH), were not statistically different between the two arms.
"The ASTER Trial builds on the results of the 3D Trial, providing additional evidence supporting the use of Penumbra System direct aspiration devices as a first-line treatment for acute ischemic stroke patients," said Adam Elsesser, chairman, chief executive officer and president of Penumbra. "The ADAPT technique with the Penumbra System as a frontline approach together with complementary adjunctive devices when needed offers a cost-effective solution for treating stroke patients, which is critical as patient access to mechanical thrombectomy is further expanded."
About ASTER Trial
The ASTER (Adapt versus StEnt Retriever) Trial is a prospective, randomized controlled study that compared the safety and efficacy of the Penumbra aspiration system used frontline as part of the ADAPT technique versus stent retrievers. The primary endpoint was end of procedure revascularization (TICI 2b/3). The study enrolled 381 patients at eight centers in France over 12 months beginning in October 2015. Penumbra provided an institutional grant to support the ASTER Trial.
About Penumbra System
The Penumbra System consists of large diameter, highly flexible, and reliably trackable reperfusion catheters that utilize the full aspiration power of the Penumbra Pump MAX™ through its Hi-Flow Aspiration Tubing. 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. The Penumbra System is the only FDA cleared integrated aspiration system for the revascularization of ischemic stroke patients.
Penumbra, Inc., headquartered in Alameda, California, is a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices. The company has a broad portfolio of products that address challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals 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 logo, ACE, and Pump MAX are trademarks of Penumbra, Inc. Other trademarks are the property of their respective owners.
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 statement s. 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; 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2015. 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.