Penumbra Indigo® Aspiration System IDE Trial for Acute Pulmonary Embolism Meets Primary Safety and Efficacy Endpoints
November 06 2019 - 4:53PM
Business Wire
Results of EXTRACT-PE Trial presented at
Vascular InterVentional Advances (VIVA) Annual Meeting
Penumbra, Inc. (NYSE: PEN), a global healthcare company focused
on innovative therapies, today announced that the EXTRACT-PE trial
successfully met the primary endpoints, demonstrating the safety
and efficacy of the Indigo® Aspiration System for aspiration
mechanical thrombectomy in patients with acute pulmonary embolism
(PE). The data were presented in the Late-Breaking Clinical Trials
session today at the Vascular InterVentional Advances (VIVA) Annual
Meeting in Las Vegas.
“The positive results of the EXTRACT-PE trial, the first
prospective safety and efficacy study of the Indigo Aspiration
System, are a step forward in building needed clinical evidence
around catheter-based embolectomy in patients with acute pulmonary
embolism,” said Akhilesh Sista, MD, FSIR, FAHA, EXTRACT-PE national
principal investigator, chief of Vascular and Interventional
Radiology at NYU-Langone School of Medicine, and vice chair of the
recently published Interventional Therapies for Acute Pulmonary
Embolism guidelines from the American Heart Association. “New AHA
guidelines state that catheter-based embolectomy may have an
important role in severe PE, but that more study is needed.
EXTRACT-PE is an important first step in determining how and when
we should employ promising and innovative catheter-based
technologies such as the Indigo aspiration device.”
EXTRACT-PE was a prospective, single-arm, multicenter trial
conducted under an Investigational Device Exemption (IDE) from the
U.S. Food and Drug Administration (FDA) that evaluated the safety
and efficacy of the Indigo Aspiration System in the treatment of
acute pulmonary embolism (ClinicalTrials.gov Identifier
NCT03218566). The study enrolled 119 participants across 22 U.S.
study centers. The primary efficacy endpoint was met with a
significant mean reduction in right ventricular (RV)/left
ventricular (LV) ratio of 0.43, corresponding to a 27.3% reduction,
at 48 hours after intervention. The primary safety endpoint was
reached with a low major adverse event composite rate of 1.7%
within 48 hours. The major adverse event composite included
device-related death, major bleeding, and device-related serious
adverse events as measured by the clinical events committee.
Additional data reported included median time of Indigo System
usage (37 minutes) and median ICU stay (one day). No thrombolytic
drugs were used in 98.3% of patients.
“From a pulmonologist’s perspective, the results of the
EXTRACT-PE trial are another important dataset that help broaden
the mechanical treatment options for patients with pulmonary
embolism,” said Victor F. Tapson, MD, pulmonary critical care
specialist at Cedars-Sinai Medical Center in Los Angeles and
EXTRACT-PE steering committee member. “The safety profile of the
Indigo System and the low rate of bleeding events, combined with
the significant reduction in RV/LV ratio seen in the EXTRACT-PE
trial, can positively impact the emerging field of acute pulmonary
embolism intervention.”
“The Indigo Aspiration System has demonstrated tremendous
potential to address patients with clot in other parts of the body,
and today’s data show its specific potential in the pulmonary
arteries,” said Adam Elsesser, chairman and chief executive officer
of Penumbra. “Pulmonary embolism is a deadly disease where we see
an unmet clinical need and patient opportunity, and we commend the
dedication of physicians who are focused on addressing this area.
We are excited about the excellent results of this trial and look
forward to working together with physicians in the field to bring
better treatment options to patients.”
About Acute Pulmonary Embolism
Pulmonary embolism (PE) is a condition that occurs when blood
clots, typically traveling from the veins in the legs, get caught
in the arteries of the lungs. Blood clots in the lungs can block
the lungs from absorbing oxygen, causing strain on the heart and
other organs. According to the American Heart Association, PE
affects roughly 300,000 Americans per year.1
About the Indigo System
In 2014, Penumbra introduced the Indigo System, a continuous
aspiration mechanical thrombectomy system designed to remove clot
from arteries and veins in the peripheral vasculature. The Indigo
System utilizes the Penumbra ENGINE™ aspiration source to deliver
nearly pure, continuous vacuum suction to the Indigo System
Aspiration Catheters to address thrombus in vessels of various
sizes.
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, Indigo, 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.
1 Benjamin, E.J. et al. on behalf of the American Heart
Association Council on Epidemiology and Prevention Statistics
Committee and Stroke Statistics Subcommittee. Heart disease and
stroke statistics—2019 update: a report from the American Heart
Association. Circulation. 2019;139:e56–e528.
Source: Penumbra, Inc.
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Betsy Merryman Merryman Communications
betsy@merrymancommunications.com 310-560-8176
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