Market Overview

Intact Vascular Announces Enrollment Completion of TOBA II BTK Clinical Trial


First-of-its-kind study designed to demonstrate safety and efficacy
of the Tack Endovascular System
® in treating
post-PTA dissections below the knee

Vascular, Inc.
, a developer of medical devices for minimally
invasive peripheral vascular procedures, today announced its Tack
Optimized Balloon
Angioplasty II BTK (TOBA II BTK)
clinical trial successfully completed enrollment, ahead of schedule.
This study further augments Intact Vascular's robust clinical program
and is notably the first pivotal trial investigating a permanent
vascular implant in arteries below the knee.

"Patients with critical limb ischemia (CLI) experience painful symptoms
and are at increased risk of amputation. Unfortunately, therapeutic
options are very limited, and no scaffolding solutions are currently
FDA-approved for BTK interventions," commented George Adams, M.D.,
M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC
Rex Hospital, Raleigh, North Carolina, Co-Principal Investigator for the
TOBA II BTK study. "The potential to have a treatment option that
maintains vessel integrity and improves blood flow will have a
significant clinical impact for treating patients with below-the-knee

With enrollment completed at 41 U.S. and European sites, the TOBA II BTK
trial is a single arm, prospective study to investigate the safety and
efficacy of the Tack Endovascular System for the repair of
post-angioplasty dissections in the mid/distal popliteal, tibial and
peroneal arteries. All patients enrolled (n=233) suffered from CLI,
underwent standard balloon angioplasty, and consequently experienced at
least one dissection requiring repair.

"Dissections are an expected consequence from balloon angioplasty, yet
can have significant implications for patients," stated Patrick
Geraghty, M.D., Professor of Surgery and Radiology at the Washington
University School of Medicine in St. Louis, Missouri and Co-Principal
Investigator for the TOBA II BTK trial. "Early results with the Tack
implant are promising, and I look forward to integrating this technology
into my below-the-knee treatment algorithm."

"Reaching full enrollment for our TOBA II BTK study is an important
milestone for below-the-knee interventions," commented Peter Schneider,
M.D., Vascular Surgeon, Co-Founder and Chief Medical Officer of Intact
Vascular. "As the first dissection repair device purpose-built for use
in these small vessels, we are excited to provide a solution for
patients suffering the painful and debilitating effects of critical limb
ischemia and who currently do not have adequate treatment options
available. The Tack implant is a novel adjunct therapy that
should diminish the chance that these patients will require an

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 improve peripheral balloon angioplasty results in
the treatment of peripheral arterial disease. Pre-loaded with six
self-expanding nitinol devices for above-the-knee (ATK) interventions,
or four for below-the-knee (BTK) interventions, the Tack Endovascular
System can be deployed to treat multiple dissections using a single
catheter and leaving behind >70% less metal than stents1.
Additionally, the Tack Endovascular System offers low radial force,
designed to promote healing, improve outcomes and preserve future
treatment options for PAD and critical limb ischemia (CLI) patients.
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 BARD Lutonix® drug-coated
balloon (DCB) in arteries above the knee. TOBA II BTK is investigating
the combination of the Tack implant with plain balloon angioplasty in
the arteries below the knee and has just completed enrollment. 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.

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.

CAUTION: Investigational device. Limited by Federal (United
States) law to investigational use.

Tack Endovascular System® and Tack® are trademarks of Intact Vascular,

Lutonix® is a registered trademark of C.R.BARD, Inc.

IN.PACT(TM) Admiral(TM) are trademarks of Medtronic, Inc.

The Tack Endovascular System® is CE Mark Authorized under EC Directive

Not available for sale or use in the United States.

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