Intact Vascular’s Tack Endovascular System® is highlighted as a
treatment option for post-PTA dissections
WAYNE, Pa.–(BUSINESS WIRE)–Intact
Vascular, Inc., a developer of medical devices for minimally
invasive peripheral vascular procedures, today welcomed the
peer-reviewed publication, “Dissections After Infrainguinal Percutaneous
Transluminal Angioplasty (PTA): Systematic Review and Current State of
Clinical Evidence” currently available online, with the print article
scheduled to be published in the August issue of Journal of
Endovascular Therapy.
“Understanding the outcomes of PTA-induced dissections has become
increasingly important as we develop new therapies to optimize
endovascular treatment of peripheral artery disease,” commented Ehrin
Armstrong, MD, Director, Interventional Cardiology, Rocky Mountain
Regional VA Medical Center, Denver, CO and lead author of the article.
“Establishing a new classification system addressing factors specific to
peripheral dissections will have a significant impact on how I treat my
patients with lower extremity occlusive disease.”
PTA remains the cornerstone of endovascular treatment, with subsequent
dissections a common occurrence. Often overlooked, underdiagnosed and
left untreated, PTA-induced dissections may lead to acute procedural
complications or restenosis requiring use of adjunct therapies, such as
stent placement, which often limits future treatment options.1
The Journal of Endovascular Therapy’s publication focuses on the
prevalence, clinical impact, and treatment of dissections post-PTA, with
a goal of analyzing current data and identifying knowledge gaps to
direct future research.
“This robust, peer-reviewed analysis further supports the importance of
accurately identifying and treating post-PTA dissections. We are pleased
the Tack® implant is highlighted as a suggested treatment
approach,” said Peter Schneider, MD, Vascular Surgeon and Co-Founder and
Chief Medical Officer of Intact Vascular.
About Intact Vascular and the Tack Endovascular System®
Intact Vascular is a privately held medical device company that develops
minimally- invasive peripheral vascular products. The Tack Endovascular
System is designed to repair dissections following peripheral balloon
angioplasty. Pre-loaded with six self-expanding nitinol implants for
above-the-knee (ATK) interventions, the Tack Endovascular System can be
deployed to treat multiple dissections using a single catheter and
leaving behind >70% less metal than stents.2 Additionally,
the Tack Endovascular System is designed to minimize vessel
inflammation, promote healing, improve outcomes and preserve future
treatment options for peripheral arterial disease patients. Visit www.intactvascular.com/
for more information.
Intact Vascular Clinical Program
Intact Vascular is sponsoring three clinical trials to evaluate its Tack
Endovascular System: TOBA II, TOBA II BTK and TOBA III. TOBA II is
investigating the combination of the Tack implant with plain angioplasty
balloons and the BD Interventional Lutonix® drug-coated
balloon (DCB) in arteries above the knee and has completed its primary
endpoint analysis. TOBA II BTK has completed enrollment and is
investigating the combination of the Tack implant with plain balloon
angioplasty in the arteries below the knee. TOBA III has completed
enrollment in Europe and is investigating the combination of the Tack
implant with the Medtronic IN.PACT® Admiral®
(DCB), with a long lesion subset.
This press release contains “forward-looking statements” concerning the
development of Intact Vascular’s products, the benefits and attributes
of such products, and the company’s expectations regarding its
prospects. Forward-looking statements are subject to risks, assumptions
and uncertainties that could cause actual future events or results to
differ materially from such statements. These statements are made as of
the date of this press release. Actual results may vary. Intact Vascular
undertakes no obligation to update any forward-looking statements for
any reason.
1 Armstrong EA, Brodmann M, Deaton DA et al. Dissections
after infrainguinal percutaneous transluminal angioplasty: a systematic
review and current state of clinical evidence. J Endovasc Ther
2019; doi:10.1177/1526602819855396.
2Bosiers
M, Scheinert D, Hendricks JMH et al. Results from the Tack Optimized
Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal
metal implants for dissection repair after angioplasty. J Vasc Surg
2016;64:109-16.
Tack Endovascular System® and Tack® are registered
trademarks of Intact Vascular, Inc.
Lutonix® is a
registered trademark of BD Interventional.
IN.PACT® and
Admiral® are registered trademarks of Medtronic, Inc.
The
Tack Endovascular System® is CE Mark Authorized under EC
Directive 93/42/EEC.
Tack Endovascular System (6F) granted FDA PMA
approval April 2019.
Contacts
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
