Market Overview

Penumbra Launches Latest Advancements in Stroke Thrombectomy Aspiration Technology

Share:

Positive early clinical experience with new Penumbra JET™ Reperfusion
Catheters and Penumbra ENGINE™ Aspiration Source

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.

About Penumbra

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.

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, 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.

View Comments and Join the Discussion!