Intact Vascular, Inc., a developer of medical devices for minimally
invasive peripheral vascular procedures, today welcomed the publication
of the iDissection Classification trial results in the current issue of Journal
of Invasive Cardiology.
Post-percutaneous transluminal angioplasty (“PTA”) dissections are often
overlooked, underdiagnosed and left untreated. These dissections can
compromise clinical outcomes in both the short and long term. The use of
intravascular ultrasound (IVUS) has been found to help visualize the
presence and severity of dissections not typically seen on angiography.
In the iDissection study, 15 patients with femoropopliteal disease were
treated with atherectomy and adjunctive PTA. Angiographic and IVUS
images utilizing ChromaFlo Imaging (Philips) were obtained at
baseline, post-atherectomy and post-angioplasty and evaluated for the
presence and severity of dissections. Dissections seen on angiography
were graded per the NHLBI scale, and IVUS images were graded using the
iDissection classification. All images were independently adjudicated by
multiple core laboratories. While angiography identified 8 dissections,
IVUS revealed 46 dissections—a ratio of 6:1. The iDissection study
reveals that significant dissections may not be thoroughly observed with
angiography yet are substantially more visible when using IVUS,
potentially altering the course of patient treatment in real-time.
“Angiography is a suboptimal test to visualize the peripheral arteries.
It underestimates vessel size, the presence and extent of calcium,
thrombus and stenosis, and does not give a clear picture of optimal
stent expansion and apposition. Moreover, the iDissection data confirms
that angiography seriously underestimates the presence and severity of
dissections following endovascular intervention,” commented Dr. Nicolas
W. Shammas, Founder and Research Director, Midwest Cardiovascular
Research Foundation, Davenport, Iowa. “The iDissection study validates
the need for more sophisticated imaging, such as IVUS, to evaluate acute
“We are very pleased with the results from the iDissection study and the
expanding evidence incorporating IVUS as a useful tool to identify
dissections often missed when using conventional angiography,” said
Bruce Shook, Intact Vascular’s President and CEO. “The Tack Endovascular
System® is specifically designed to repair dissections while
leaving minimal metal in the artery, thereby reducing mechanical stress
on the arterial wall and preserving future treatment options.”
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 both plain
angioplasty balloons and the BARD Lutonix® drug-coated
balloon (DCB) in the arteries above the knee, and completed enrollment
in March 2017. TOBA II BTK is investigating the combination of the Tack
implant with plain balloon angioplasty in the arteries below the knee
and is actively enrolling patients. TOBA III has completed enrollment in
Europe and is investigating the combination of the Tack implant with the
Medtronic IN.PACT™ Admiral™ (DCB), inclusive of long lesions.
About Intact Vascular
Intact Vascular is a privately held medical device company that develops
minimally-invasive peripheral vascular products. The Tack Endovascular
System is designed to improve peripheral balloon angioplasty results in
the treatment of peripheral arterial disease. Visit www.intactvascular.com
for more information.
This press release contains “forward-looking statements” concerning the
development of Intact Vascular’s products, the potential 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.
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