Penumbra to Launch LanternTM Microcatheter, Present Final Results of Multicenter Prism Trial on Indigo® System at SIR 2016
ALAMEDA, Calif. –
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 2-7th. 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.
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 SeparatorTM 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.
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Merryman Communications
Betsy Merryman, 310-560-8176
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