Intact Vascular to Announce One-Year Data from TOBA III Clinical Trial

Study Investigates Use of the Tack Endovascular System® for Focal Dissection Repair Following Drug-Coated Balloon Angioplasty in PAD Patients

WAYNE, Pa.--()--Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that the one-year data from its Tack Optimized Balloon Angioplasty (TOBA) III clinical trial will be presented during the High Impact Clinical Research session of the 31st Transcatheter Cardiovascular Therapeutics (TCT) meeting, the annual scientific symposium of the Cardiovascular Research Foundation.

Conducted in Europe, this multi-center, single-arm, prospective study investigates the combination of the Tack Endovascular System with the market leading drug-coated balloon, Medtronic’s IN.PACTAdmiralDCB, as a treatment in the superficial femoral (SFA) and/or proximal popliteal (PPA) arteries. The study enrolled 201 patients, all suffering from peripheral arterial disease (PAD) and includes a subset with long arterial lesions.

“The TOBA III data being presented at this year’s TCT meeting augments the already robust clinical evidence supporting the use of Tack implants to treat post-angioplasty dissections,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “We look forward to sharing the findings of the TOBA III trial and further demonstrating the impact this new, minimal metal therapeutic paradigm offers for patients suffering from peripheral arterial disease.”

Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, Medical University of Graz, Austria and Principal Investigator of the TOBA III trial, will present the one-year data on Friday, September 27th at 2:30 pm PST in the Innovation & Keynote Theater at the Moscone Center in San Francisco, California.

Additionally, Dr. Ehrin Armstrong, Director of Interventional Cardiology at the Rocky Mountain Regional VA Medical Center in Denver, Colorado, will present Clinical Trial Updates: BTK Tacks Scaffolds and Drugs during the Revascularization Strategies in CLI - State of the Art session during the TCT Endovascular: An Alliance Partner with the VEITHsymposium, on Wednesday, September 25th at 11:01 am PST in Room 156/158.

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 its primary endpoint analysis and is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee. TOBA III has completed its primary endpoint analysis 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 trademarks of Medtronic, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
“Tack Endovascular System (6F) FDA approved for use in the superficial femoral and proximal popliteal arteries, ranging from 3.5mm to 6.0mm RVD, for treatment of post-PTA dissections.”
"Tack Endovascular System (4F) CAUTION: Investigational device. Limited by Federal (United States) law to investigational use."

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048