MIAMI–(BUSINESS WIRE)–Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. commercial availability of the Penumbra System’s most advanced technology – the Penumbra JET 7 Reperfusion Catheter with XTRA FLEX technology – at the Society of NeuroInterventional Surgery (SNIS) 16th Annual Meeting in Miami. Penumbra JET 7 with XTRA FLEX technology is used with the Penumbra ENGINE™ in the fully integrated Penumbra System® – an aspiration-based mechanical thrombectomy system that enables physicians to extract thrombus in acute ischemic stroke patients.
The Penumbra JET 7 Reperfusion Catheter with XTRA FLEX technology is the latest advancement in the Penumbra System JET – ENGINE family of products, which was launched last September. As the Penumbra System’s eighth generation reperfusion catheter for proximal large vessel occlusions, the catheter is designed for advanced trackability and navigation, and maintains the large 0.072” lumen. Penumbra JET 7 with XTRA FLEX technology, together with the power of the Penumbra ENGINE, are designed to maximize thrombus removal force.
Initial clinical experience with the Penumbra JET 7 with XTRA FLEX technology will be shared today from 12:45-1 p.m. Eastern Daylight Time in the Industry Technology Luncheon Symposium by Donald F. Frei, M.D., director of Neuro-Interventional Surgery, Swedish Medical Center, Englewood, Colorado.
Penumbra booth #614, in the exhibit hall, will feature the Penumbra JET 7 with XTRA FLEX technology and Penumbra ENGINE, together with the company’s broad range of access and embolization products. In addition, MVI Health Inc., a Penumbra subsidiary, will also be exhibiting at the meeting.
About the Penumbra System
The Penumbra System is a fully integrated system designed specifically for mechanical thrombectomy by aspiration that first received 510(k) clearance by the U.S. Food & Drug Administration in December 2007. 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. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusion. The latest generation of the Penumbra System features the Penumbra JET 7 with XTRA FLEX technology and Penumbra JET D Reperfusion Catheters, the 3D Revascularization Device™, and Penumbra ENGINE and accessories. The Penumbra System includes the new Penumbra JET 7 Reperfusion Catheter with XTRA FLEX technology powered by the Penumbra ENGINE, offering the highest thrombus removal force for revascularization of acute ischemic stroke patients with large vessel occlusions. Thrombus removal force is calculated based on catheter tip size and vacuum level of the aspiration source.
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.
About Penumbra
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets innovative products and has a broad portfolio that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and 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 P logo, Penumbra System, Penumbra JET, 3D Revascularization Device and Penumbra ENGINE are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com.
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, 2018. 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.
Contacts
Betsy Merryman
Merryman Communications
betsy@merrymancommunications.com
310-560-8176
