Intact Vascular Announces Positive One-Year Data from TOBA III Clinical Trial

Posted on September 30, 2019 by Medtech[y] Staff


Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the positive one-year results of its Tack Optimized Balloon Angioplasty (TOBA) III clinical trial, successfully achieving both primary and secondary endpoints. Marianne Brodmann, M.D., Head of the Clinical Division of Angiology, Medical University of Graz, Austria and Principal Investigator of the TOBA III trial, presented the data today during the High Impact Clinical Research session of the 31st Transcatheter Cardiovascular Therapeutics (TCT) meeting, the annual scientific symposium of the Cardiovascular Research Foundation.

This multi-center, single-arm, prospective study was conducted in Europe and investigated the combination of the Tack Endovascular System with Medtronic’s IN.PACT™ Admiral™ drug-coated balloon as a treatment in the superficial femoral (SFA) and/or proximal popliteal (PPA) arteries. The study enrolled 201 patients, including 169 patients with arterial lesions ≤150 mm in length and a subset of 32 patients with long arterial lesions (>150 and ≤250mm). All patients suffered from peripheral arterial disease (PAD) and underwent balloon angioplasty, consequently experiencing at least one dissection requiring repair.

Results from the 169 patient standard lesion cohort (≤150mm) impressively demonstrated 97.7% complete dissection resolution, 95% K-M vessel patency and 97.5% K-M freedom from clinically driven reintervention at 12-months. This was accomplished with a 0.6% bailout stent rate. These outstanding results add to the large body of clinical evidence supporting the use of the Tack® System for post-PTA dissection repair and further demonstrate the long-term effectiveness of the technology.

“I am extremely pleased with the clinically compelling results of the TOBA III study,” commented Dr. Marianne Brodmann. “The Tack System provides a safe and effective solution for treating post-angioplasty dissections. I believe this new therapeutic paradigm will change the standard of care for above-the-knee interventions.”

The observational data from the long lesion subset (>150 and ≤250mm) was analyzed separately. Results from these 32 patients notably demonstrated 98.8% complete dissection resolution and 89.3% K-M vessel patency, with 96.8% K-M freedom from clinically driven reintervention at 12-months and a 0% bailout stent rate.

“The data presented today at TCT further validates the use of Tack implants to improve balloon angioplasty results,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “The data suggest that we have been implanting too much metal for far too long with traditional stents. We are thrilled to offer a minimal metal therapeutic solution that enhances patient outcomes and preserves future treatment options.”

“We would like to thank the excellent team of physicians and coordinators who contributed to the success of the TOBA III study,” stated Bruce Shook, Intact Vascular’s President and CEO. “The results presented today are the most impressive reported to date for balloon angioplasty in above-the-knee arterial disease. We look forward to offering this technology to more patients as we continue the rapid expansion of our commercial efforts.”

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. To learn more about Intact Vascular’s clinical program, please visit https://www.intactvascular.com....

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."