BOSTON--(BUSINESS WIRE)--Penumbra, Inc. (NYSE:PEN), a global interventional therapies company, today announced U.S. commercial availability of its most advanced thrombectomy device, the ACE™68 Reperfusion Catheter, part of the fully integrated Penumbra System®, at the Society of NeuroInterventional Surgery (SNIS) 13th Annual Meeting in Boston, Massachusetts.
The ACE68 Reperfusion Catheter leverages the latest advancements in tracking technology to deliver maximum aspiration power easily and safely for extracting thrombus in acute ischemic stroke patients.
Clinical experience with the ACE68 will be shared today from 1:30-1:45 p.m. ET in the Industry Technology Luncheon Symposium by Blaise Baxter, M.D., chief of radiology at Erlanger Hospital in Tennessee and chairman of radiology for the University of Tennessee College of Medicine Chattanooga.
“The tracking technology of the ACE68 Reperfusion Catheter is the most advanced,” said Baxter. “In my clinical experience with the ACE68, I saw the device easily navigate difficult tortuosity that would have challenged other devices. ACE68’s tracking performance, combined with a large aspiration lumen to enable efficient clot removal, make ACE68 the most compelling frontline device in stroke intervention.”
The ACE68 Reperfusion Catheter was engineered on a new, innovative tracking platform from hub to tip. Featuring a unique coil winding geometry along 16 transitions to create the optimal tracking profile, ACE68 is designed to ensure easy tracking through tortuosity that is typical in acute ischemic stroke patients. ACE68 is powered to extract clot en masse quickly and effectively as part of the fully integrated Penumbra System.
“With the ACE68 Reperfusion Catheter, I can easily deliver full aspiration power to the occlusion,” said Johanna Fifi, M.D., assistant professor of neurology, neurosurgery and radiology at The Mount Sinai Hospital and director of the Endovascular Stroke Program at the Mount Sinai Health System in New York. “The ACE68’s large lumen increases the likelihood of capturing the clot fully within the catheter or the canister, potentially reducing the number of passes to achieve complete revascularization and minimize ENT (embolization to new territory).”
“The ACE68 provides an opportunity to reverse strokes faster and with less expense,” said Adam Arthur, M.D., MPH, FACS, professor, Department of Neurosurgery, UTHSC, Semmes-Murphey Neurologic & Spine Institute. “The larger lumen seems to allow better clot capture, which may reduce the need for adjunctive devices, simplify the procedure and reduce procedure cost -- important considerations as hospitals look to expand stroke services.”
The ACE68 represents the latest advances in tracking technology to deliver a large bore reperfusion catheter easily and reliably through tortuosity that is typical in acute ischemic stroke patients.
“We designed the ACE68 with the intent to make real improvement on stroke procedure time, outcome and cost. The early reports from physicians on the performance of ACE68 confirm that this is the most impactful stroke product we have ever developed,” said Adam Elsesser, chairman and chief executive officer of Penumbra.
About the ACE68 Reperfusion Catheter and the Penumbra System
The Penumbra System with the ACE68 Reperfusion Catheter is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within eight hours of symptom onset. The Penumbra System consists of large, highly pliable and trackable Reperfusion Catheters that utilize the full aspiration power of the Penumbra Pump MAX™ within an integrated, proprietary system to remove the stroke-causing occlusion safely and effectively. The Penumbra System offers a complete suite of reperfusion catheters sized optimally for large vessel occlusions.
The Penumbra System with the ACE68 Reperfusion Catheter is now available in the U.S.
About Penumbra
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 and the Penumbra logo are trademarks of Penumbra, Inc.
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; 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.
