June 18, 2019 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today welcomed the peer-reviewed publication, “Dissections After Infrainguinal Percutaneous Transluminal Angioplasty (PTA): Systematic Review and Current State of Clinical Evidence” currently available online, with the print article scheduled to be published in the August issue of Journal of Endovascular Therapy.
“Understanding the outcomes of PTA-induced dissections has become increasingly important as we develop new therapies to optimize endovascular treatment of peripheral artery disease,” commented Ehrin Armstrong, MD, Director, Interventional Cardiology, Rocky Mountain Regional VA Medical Center, Denver, CO and lead author of the article. “Establishing a new classification system addressing factors specific to peripheral dissections will have a significant impact on how I treat my patients with lower extremity occlusive disease.”
PTA remains the cornerstone of endovascular treatment, with subsequent dissections a common occurrence. Often overlooked, underdiagnosed and left untreated, PTA-induced dissections may lead to acute procedural complications or restenosis requiring use of adjunct therapies, such as stent placement, which often limits future treatment options.1 The Journal of Endovascular Therapy’s publication focuses on the prevalence, clinical impact, and treatment of dissections post-PTA, with a goal of analyzing current data and identifying knowledge gaps to direct future research.
“This robust, peer-reviewed analysis further supports the importance of accurately identifying and treating post-PTA dissections. We are pleased the Tack® implant is highlighted as a suggested treatment approach,” said Peter Schneider, MD, Vascular Surgeon and Co-Founder and Chief Medical Officer of Intact Vascular.
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.2 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 enrollment and is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee. TOBA III has completed enrollment in Europe 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.
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
1 Armstrong EA, Brodmann M, Deaton DA et al. Dissections after infrainguinal percutaneous transluminal angioplasty: a systematic review and current state of clinical evidence. J Endovasc Ther 2019; doi:10.1177/1526602819855396.
2Bosiers 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 registered trademarks of Medtronic, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Tack Endovascular System (6F) granted FDA PMA approval April 2019.