Penumbra To Launch Lanterntm Microcatheter, Present Final Results Of Multicenter Prism Trial On Indigo System At SIR 2016

ALAMEDA, Calif.--(BUSINESS WIRE)--Penumbra, Inc., a global interventional therapies company, today announced the launch of its Lantern^™ microcatheter at the upcoming Society for Interventional Radiology 2016 meeting (SIR 2016) to be held at the Vancouver Convention Center, April 2-7^th. Lantern is a low profile, high flow microcatheter designed to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral vasculature. Lantern adds to Penumbra’s growing embolization portfolio, as it aids in the delivery of Penumbra’s embolization devices, including RUBY^® Coil, POD^® (Penumbra Occlusion Device) and POD Packing Coil. In addition, the final results of the multicenter PRISM study, designed to assess the safety and efficacy of the Indigo^® System for peripheral and visceral arterial thrombi and emboli, will be presented. The Indigo System is a novel mechanical aspiration system for the removal of emboli and thrombi in the peripheral vasculature.

“Penumbra/Indigo System provides a novel aspiration thrombectomy tool in treatment of peripheral and visceral arterial occlusions – final results of the PRISM trial”

Lantern received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in December 2015. It is offered in a variety of lengths and tip shapes relevant to peripheral vascular procedures. Lantern’s distal segment is visible under fluoroscopy to aid in the navigation and visualization of the microcatheter during procedures.

“Like many Penumbra products, the Lantern microcatheter is unique in its design and helps address physician needs for a low profile, high flow microcatheter,” said Adam Elsesser, chairman and chief executive officer of Penumbra. “It is designed to track distally through the peripheral vasculature, yet can be used for high flow contrast injections, combining these desired properties into one microcatheter.”

Also, the final results of the PRISM study will be presented at SIR 2016 by Corey Teigen, M.D., Sanford Health, Fargo, ND. PRISM, which began in 2014, sought to evaluate the use of the Indigo System for patients with peripheral occlusions secondary to acute ischemia, incomplete reperfusion, and procedure-related distal emboli, using primarily the smaller size catheters of the Indigo System. “Penumbra/Indigo System provides a novel aspiration thrombectomy tool in treatment of peripheral and visceral arterial occlusions – final results of the PRISM trial” will be presented Monday, April 4 at 3 p.m. in room 224 Abstract 207.

To learn more about Penumbra’s embolization and thrombectomy devices, please join Penumbra at the following events:

• A dinner symposium on Tuesday, April 5 at 6 p.m. at the Pan Pacific Hotel, Oceanview Suite in Vancouver. James Benenati, M.D., Miami Cardiac and Vascular Institute, FL, Jafar Golzarian, M.D., University of Minnesota, MN and Bulent Arslan, M.D., Rush University Medical Center, IL, will share their experience with Penumbra’s peripheral products.
• Four physician Q&A sessions at Booth #1318 from Sunday, April 3, through Tuesday, April 5, where the audience will get the opportunity to hear from physician experts regarding the application of Penumbra technologies in their practice.

About Penumbra’s Peripheral Vascular Products
Penumbra has a growing suite of thrombectomy and embolization products for use in a range of peripheral vascular conditions:

• The Indigo System is a next-generation continuous aspiration thrombectomy device designed for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and includes four catheter sizes (CAT 3, 5, 6 and 8). The aspiration lumen is paired with a proprietary continuous vacuum aspiration pump to evacuate clot effectively and efficiently. The Indigo System’s proprietary Separator^TM technology ensures unobstructed aspiration for the duration of the procedure.
• Penumbra’s embolization platform includes RUBY, a coil system for peripheral embolization; POD (Penumbra Occlusion Device), a vascular embolization device designed specifically to occlude peripheral vessels; and POD Packing Coil, which is uniquely designed to pack very densely behind RUBY and POD to occlude arteries and veins throughout the peripheral vasculature, including aneurysms.
• The new Lantern microcatheter, which adds to Penumbra’s embolization portfolio, is designed to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral vasculature. It is offered in a variety of lengths and tip shapes relevant to peripheral vascular procedures.

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.