Intact Vascular Announces US Launch of the Tack Endovascular System® and First Commercial Use
Intact Vascular, Inc. , a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the first commercial use of its Tack Endovascular System in multiple sites across the United States.
Intact
Vascular, Inc., a developer of medical devices for minimally
invasive peripheral vascular procedures, today announced the first
commercial use of its Tack Endovascular System in multiple sites across
the United States. Recently FDA-approved for above-the-knee
interventions, the first-of-its-kind dissection repair device is
implanted post-angioplasty to resolve dissections in patients with
peripheral arterial disease (PAD).
“Dissections are an unavoidable consequence of balloon angioplasty. Now,
with the Tack Endovascular System, we have an effective minimal metal
solution to treat dissections above-the-knee, further improving our
angioplasty outcomes,” stated Dr. Nicolas W. Shammas, Founder and
Research Director, Midwest Cardiovascular Research Foundation in
Davenport, Iowa. “I am extremely pleased with my experience using Tack®
implants and believe this device will facilitate better care for
my PAD patients.”
Balloon angioplasty, whether performed with plain or drug-coated
balloons, inherently injures the vessel wall, creating dissections that
may inhibit blood flow and promote thrombosis formation. Despite the
prevalence of dissections, they are frequently underdiagnosed and left
untreated, often leading to further complications and compromised
patient outcomes.
“The Tack Endovascular System brings us unique clinical and economic
advantages in the office-based-lab setting. With six implants pre-loaded
into a single delivery system, physicians can quickly and easily provide
precision dissection repair along the vessel length,” stated Dr. John
Rundback, Vascular and Interventional Radiologist and Partner at the New
Jersey Endovascular & Amputation Prevention Services, LLC in Teaneck,
New Jersey. “This minimal metal therapy complements balloon angioplasty
and avoids the complications a larger metal stent may cause, thereby
preserving future treatment options.”
“In striving to provide the best care for patients, we actively seek new
ways to improve the results of balloon angioplasty,” said Dr. Ehrin
Armstrong, Interventional Cardiologist and Director of Interventional
Cardiology at the Rocky Mountain Regional VA Medical Center in Denver,
Colorado. “Based on my clinical experience using the Tack Endovascular
System, I anticipate this targeted therapy will become standard of care
for post-angioplasty dissection repair.”
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.1 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.
1Bosiers 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.
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