Intact Vascular Announces Positive One-Year Data from the TOBA II Clinical Trial
November 6, 2018
First-of-its-kind study designed to demonstrate safety and efficacy
of the Tack Endovascular System® in treating
post-PTA dissections
WAYNE, Pa.–(BUSINESS WIRE)–Intact
Vascular, Inc., a developer of medical devices for minimally
invasive peripheral vascular procedures, today announced at the 15th
annual VIVA conference in Las Vegas that its Tack Optimized Balloon Angioplasty
II (TOBA II) clinical trial successfully achieved both primary and
secondary endpoints. One year results from the TOBA II study were
presented in the late-breaking scientific session by William Gray, M.D.,
System Chief, Division of Cardiovascular Disease at Main Line Health,
President, Lankenau Heart Institute and Principal Investigator for the
TOBA II trial.
Notably the first peripheral vascular study to enroll patients with 100%
dissected vessels, the TOBA II study, was conducted at 33 U.S. and
European sites to investigate the Tack Endovascular System for the
repair of post-angioplasty dissections in femoropopliteal arteries. All
patients enrolled (n=213) suffered from peripheral arterial disease
(PAD), underwent balloon angioplasty with either plain or drug-coated
balloons, and consequently experienced at least one dissection, with
69.4% being classified as severe.
Impressive results presented from this first-of-its-kind study
demonstrated 92.1% complete dissection resolution within a clinically
challenging patient population, along with 79.3% K-M vessel patency and
86.5% K-M freedom from clinically driven reintervention at 12-months.
Additionally, the TOBA II study validated the Tack® implants
as stable and durable, with zero implant fractures, 99.9% freedom from
migration, and a 0.5% bailout stent rate.
“The TOBA II study is unique in that it is the first large scale pivotal
evaluation in peripheral arterial vessels that are 100%
dissected following initial angioplasty and treated with a precisely
targeted implant,” commented Dr. William Gray. “This study introduces a
new therapeutic paradigm, demonstrating that we can repair dissected
arteries, leaving minimal metal behind to preserve future treatment
options for our patients, and producing excellent 12-month outcomes.”
“As presented today, the TOBA II data further augment the growing body
of evidence supporting the idea that a purpose-built implant for
dissection repair can enhance the clinical results of balloon
angioplasty,” said Bruce Shook, Intact Vascular’s President and CEO.
“The Tack Endovascular System is also well aligned with a primary goal
of endovascular operators: to leave as little metal behind as possible.”
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,
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. 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 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 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.
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, Inc.
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 93/42/EEC.
Not available for
sale or use in the United States.
Contacts
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048