Penumbra Launches Latest Advancements in Stroke Thrombectomy Aspiration Technology
ALAMEDA, Calif.--(BUSINESS WIRE)--Sep 4, 2018--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: Penumbra JET 7 and Penumbra JET D Reperfusion Catheters powered by the Penumbra ENGINE aspiration source. All are part of the fully integrated Penumbra System ® that utilizes aspiration-based mechanical thrombectomy for stroke revascularization. The Penumbra JET 7 and JET D Reperfusion Catheters deliver deep vacuum aspiration power of the Penumbra ENGINE to enable physicians to extract thrombus effectively and safely in acute ischemic stroke patients.
The Penumbra JET 7 is the Penumbra System’s seventh generation reperfusion catheter for proximal large vessel occlusions, and JET D Reperfusion Catheter is designed specifically for distal occlusions. JET 7 Reperfusion Catheter has a large 0.072” lumen for deep vacuum aspiration and is designed for trackability and navigation, featuring 20 transitions from the proximal shaft to distal tip, a progressive distal coil wind for superior flexibility and Quad-Wire technology in the proximal shaft for enhanced pushability. JET D brings deep vacuum aspiration power to distal occlusions with a smaller profile.
“The JET 7 Reperfusion Catheter with its advanced tracking technology and large 0.072” aspiration lumen is the most advanced device for stroke. In my clinical experience, I was able to easily and quickly navigate the JET 7 through tortuous anatomy to the face of the clot and achieve full revascularization after a single pass,” said Alejandro M. Spiotta, MD, Medical University of South Carolina, Charleston, S.C. “We know from our own published experience that increases in aspiration lumen size have led to faster recanalization times and higher likelihood of success at first pass without compromising safety. I eagerly await collecting and publishing our clinical experience with JET 7.”
Both JET 7 and JET D are supported by Penumbra’s third generation aspiration source, Penumbra ENGINE, which offers the deepest vacuum available with the Penumbra System. Penumbra ENGINE offers near perfect vacuum (-29.2 in Hg) and features a new sleek simple design with one-touch aspiration control, a new canister with integrated clot catcher and LED canister lighting. Together, the Penumbra System with the new Penumbra JET 7 Reperfusion Catheter powered by the Penumbra ENGINE offers the highest thrombus removal force for revascularization of acute ischemic stroke patients with large vessel occlusions.
“The JET 7 and JET D along with the new ENGINE provide a suite of tools to effectively address both proximal and distal occlusions,” said Ian Kaminsky, MD, MS, Radiology Imaging Associates/Swedish Medical Center, Englewood, Colorado. “In our initial case experience, we saw the easy tracking of the JET 7 and JET D in a range of tortuous conditions and vessel locations that, combined with the deep vacuum of the ENGINE, offer the potential to increase our rate of complete first pass revascularization while decreasing procedure times.”
“Penumbra is delighted to usher in our next phase of innovation with the introduction of the Penumbra JET 7, JET D and ENGINE,” said Adam Elsesser, chairman and chief executive officer of Penumbra. “Each phase of innovation – original Penumbra System, MAX™ and ACE™ systems, and now JET and ENGINE – represents a significant improvement in performance and the opportunity to further help patients experiencing acute ischemic stroke.”
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 and JET D Reperfusion Catheters, Hi-Flow Aspiration Tubing, the 3D Revascularization Device™ and Penumbra ENGINE and accessories. The Penumbra System with the new Penumbra JET 7 Reperfusion Catheter powered by the Penumbra ENGINE offers 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.
Penumbra, Inc., headquartered in Alameda, Calif., is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra, the Penumbra P logo, Penumbra System, Penumbra JET, ACE, 3D Revascularization Device, MAX and Penumbra ENGINE are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com.
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, 2017. 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.
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SOURCE: Penumbra, Inc.
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PUB: 09/04/2018 07:00 AM/DISC: 09/04/2018 07:01 AM