Surmodics Announces Successful Early Clinical Use of Pounce™ LP (Low Profile) Thrombectomy System, Designed to Address a Critical, Unmet Need by Facilitating Removal of Thrombi and Emboli Below the Knee
January 22 2024 - 7:30AM
Business Wire
Addition of a low-profile device to the Surmodics Pounce™
thrombectomy platform allows for efficient clot removal in
peripheral arteries ranging from 2 mm to 4 mm, such as those found
below the knee
Surmodics, Inc. (Nasdaq: SRDX), a leading provider of
medical device and in vitro diagnostic technologies, today
announced successful early clinical use of the company’s Pounce™ LP
(Low Profile) Thrombectomy System. The Pounce LP Thrombectomy
System, which received U.S. Food and Drug Administration (FDA)
clearance in June 2023, is currently in limited market evaluation
(LME), with full commercial launch planned following completion of
the LME.
Surmodics’ Pounce Thrombectomy devices are intended for the
non-surgical removal of thrombi and emboli from the peripheral
arterial vasculature. The new Pounce LP Thrombectomy System is
indicated for use in vessels ranging from 2 mm to 4 mm in diameter,
sizes typical of vessels found below the knee. The Pounce LP System
complements the original Pounce Thrombectomy System, introduced in
2021, which is indicated for use in vessels 3.5 mm to 6 mm in
diameter.
Dr. Lucas Ferrer Cardona,* a vascular surgeon with the Dell
Seton Medical Center at the University of Texas Hospital in Austin,
was the first physician to use the Pounce LP System.
“In our first use of the device, the Pounce LP Thrombectomy
System performed exceptionally well in helping our team restore
blood flow to the foot for a limb-threatened patient,” he said.
“Using the device, we promptly removed acute and subacute thrombus
from the mid-peroneal artery below the knee with no adjunctive use
of thrombolytics and no embolization. Thrombi or emboli in
below-the-knee vessels have traditionally been very challenging to
remove. I believe this device holds great promise in filling a
major gap in our treatment algorithm.”
Dr. Elizabeth Genovese, a vascular surgeon at the Hospital of
the University of Pennsylvania who has experience using the
original Pounce System, is among several other satisfied early
users of the Pounce LP System. She recently deployed the Pounce LP
device to revascularize a patient with arterial occlusions in both
the anterior tibial and peroneal arteries.
“The Pounce LP System allowed me to treat chronic thrombus in
these vessels with the effectiveness I’d expect from open surgical
Fogarty embolectomy while maintaining the advantages of an
endovascular approach for treating underlying and distal disease,”
she said. “We were able to achieve an optimal outcome in a very
complex lesion, and this type of result would not have been
possible without this device.”
“We’re very pleased with the successful early clinical use of
the Pounce LP Thrombectomy System, which will extend the range of
treatment for our Pounce platform to include removal of organized
thrombotic or embolic clots from the iliac arteries in the pelvis
down to tibial vessels below the knee,” said Gary Maharaj,
President and Chief Executive Officer of Surmodics. “Downstream
embolization of chronic material into below-the-knee arteries
during an endovascular procedure can be an interventionist’s
nightmare, sometimes requiring surgical rescue. The Pounce LP
System’s ability to capture and remove these unexpected emboli adds
yet more value to this device for BTK revascularization.”
About the Pounce Thrombectomy Platform
The Pounce System is the first mechanical thrombectomy device
designed to remove acute-to-chronic thrombi and emboli in occluded
peripheral arteries without the need for capital equipment or
aspiration and minimizing the use of thrombolytics. Described as a
“grab-and-go” solution, the Pounce System is both readily
deployable and simple to use. The System is composed of three
components: a delivery catheter, a basket wire, and a funnel
catheter. The basket wire is delivered distal to the location of
the thrombus, deploying two nitinol self-expanding baskets. The
baskets capture the clot and are retracted into the nitinol
collection funnel. With the clot entrained, the System is withdrawn
into a minimum 7 Fr guide sheath through which the clot is removed
from the body. The Pounce Thrombectomy platform includes two
different-sized devices: the original Pounce™ Thrombectomy System,
indicated for use in peripheral arterial vessels 3.5 mm to 6 mm in
diameter, and the Pounce LP (Low Profile) Thrombectomy System,
indicated for use in peripheral arterial vessels 2 mm to 4 mm in
diameter.
In a retrospective study 3 of 44 consecutive patients treated
for lower extremity limb ischemia with suspected thrombus using the
original Pounce System (acute, subacute, and chronic clot),
investigators achieved 83% success in effectively removing thrombus
from the arterial segments in which the device was used. Adjunctive
thrombolysis was used to resolve thrombus at a Pounce System
treatment site in just 5.6% (2 of 44) cases.
About Surmodics, Inc.
Surmodics is a leading provider of performance coating
technologies for intravascular medical devices and chemical and
biological components for in vitro diagnostic immunoassay tests and
microarrays. Surmodics also develops and commercializes highly
differentiated vascular intervention medical devices that are
designed to address unmet clinical needs and engineered to the most
demanding requirements. This key growth strategy leverages the
combination of the Company’s expertise in proprietary surface
modification and drug-delivery coating technologies, along with its
device design, development, and manufacturing capabilities. The
Company’s mission is to improve the detection and treatment of
disease. Surmodics is headquartered in Eden Prairie, Minnesota. For
more information, visit www.surmodics.com. The content of
Surmodics’ website is not part of this press release or part of any
filings that the company makes with the Securities and Exchange
Commission.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements.
Statements that are not historical or current facts, including
statements regarding what the Pounce LP Thrombectomy System is
designed to address, the planned full commercial launch of the
product, the promise of the product, and Surmodics’ strategy, are
forward-looking statements. Forward-looking statements involve
inherent risks and uncertainties, and important factors could cause
actual results to differ materially from those anticipated,
including the results of the limited market evaluation of the
Pounce LP Thrombectomy System, adoption of the product, and the
factors identified under “Risk Factors” in Part I, Item 1A of our
Annual Report on Form 10-K for the fiscal year ended September 30,
2023, and updated in our subsequent reports filed with the SEC.
These reports are available in the Investors section of our website
at https://surmodics.gcs-web.com and at the SEC website at
www.sec.gov. Forward-looking statements speak only as of the date
they are made, and we undertake no obligation to update them in
light of new information or future events.
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* Consultant for Surmodics
- Gray BH, Wheibe E, Dicks AB, Low ML, Tingen JS. Pounce
Thrombectomy System to Treat Acute and Chronic Peripheral Arterial
Occlusions. Ann Vasc Surg. 2023;96:104-114.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240122060188/en/
Surmodics Investor Inquiries: Jack Powell, Investor Relations
ir@surmodics.com Surmodics Public Relations Inquiries:
pr@surmodics.com
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