Intact Vascular Announces Presentation of TOBA II Pivotal Data
October 8, 2018
Data to be presented as a Late-Breaking Clinical Trial at the 2018
VIVA Conference
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally
invasive peripheral vascular procedures, today announced that data from
its Tack Optimized Balloon Angioplasty (TOBA) II pivotal clinical trial
will be presented at the 15th Annual VIVA Conference in Las
Vegas, NV on November 5-8.
The TOBA II trial is the first-of-its-kind designed to investigate the
safety and efficacy of the Tack Endovascular System® for the
repair of post-angioplasty dissections in femoropopliteal arteries. The
Tack Endovascular System, a dissection repair device that is pre-loaded
with 6 self-expanding nitinol devices for above-the-knee (ATK)
interventions, can be deployed to treat multiple dissections using a
single catheter and leave behind >70% less metal than stents.1
Patients with peripheral arterial disease (PAD) who are treated with
balloon angioplasty often suffer from dissections or tears in the artery
wall. Dissections can result in acute thrombosis and occlusions if left
untreated, and can lead to recurrent or worsening symptoms and repeat
procedures.
“The TOBA II data being presented at VIVA provide important clinical
evidence regarding the therapeutic effectiveness of treating dissections
with Tack® implants in a challenging patient population,”
said Peter Schneider, MD, Vascular Surgeon at Kaiser Permanente in
Honolulu, Hawaii, and Co-Founder and Chief Medical Officer of Intact
Vascular. “Patients with peripheral arterial disease who are treated
with balloon angioplasty and suffer dissections, or tears, in their
artery wall are subject to increased risk of occlusions. We look forward
to sharing the findings from the TOBA II trial, a first-of-its-kind
pivotal trial studying the Tack Endovascular System in patients with
100% dissected vessels.”
Additional presentations of interest related to the Tack Endovascular
System are listed below in Pacific Time and will take place at the Wynn
Las Vegas.
Monday, November 5
1:15PM: When and How to Bail Out After POBA of the Tibial and Pedal
Vessels: George Adams, MD
Tuesday, November 6
9:27AM: Late-Breaking Clinical Trial – TOBA II 12-month Pivotal Trial
Results: William Gray, MD
4:00PM: Stent Technology Has Dramatically Improved Results in the
Fem-Pop Segment: Review of Available and Upcoming Scaffolds: Saher
Sabri, MD
Wednesday, November 7
2:15PM: Tack-Optimized Angioplasty: Its Role in BTK and Early Results:
Marianne Brodmann, MD
Thursday, November 8
7:05AM: Post-Angioplasty Tibial Dissection Repair: Patrick Geraghty, MD
9:05AM: Comparative SFA Technologies, Self-Expanding Nitinol Scaffolds:
William Gray, MD
9:10AM: Limb Salvage Pearls: Strategies for Optimizing Acute Results of
BTK Intervention: Balloon Sizing, Best Minimal Lumen Diameter, Managing
Dissections, and More: Francesco Liistro, MD
2:15PM: Assessment of Post-DCB Dissections: Deciding Which to Treat and
How: Ehrin Armstrong, MD
For more information, visit the Intact Vascular booth #206 during VIVA.
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. 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,
which has completed enrollment in Europe, is investigating the
combination of the Tack implant with the Medtronic IN.PACT™ Admiral™
(DCB), inclusive of long lesions.
Visit http://www.intactvascular.com/clinical-trials/current-clinical-trials/
for more information on Intact Vascular’s robust clinical
development program in the endovascular treatment of peripheral arterial
disease and critical limb ischemia.
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 therapeutic potential 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. |
Bosiers M, Scheinert D, Hendriks JMH et al. Results from the Tack |
||
|
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use. |
|
The Tack Endovascular System is CE Mark Authorized under EC Directive 93/42/EEC. |
|
The Tack Endovascular System is not approved for sale or use in the United States. |
|
Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc. |
| Lutonix® is a trademark of C.R. BARD, Inc. |
|
IN.PACT(TM) Admiral(TM) are trademarks of Medtronic |
Contacts
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048