Study Demonstrates Safety and Efficacy of Intact Vascular’s Tack® Implants for Focal Dissection Repair in Complex Lesions
October 29, 2019 – WAYNE, Pa.–(BUSINESS WIRE)– Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the peer-reviewed publication, “Practical Applications of Tack Implants for Infrainguinal Dissection Repair: A Single-Center Experience” currently available online, with the article scheduled to be published in the February 2020 issue of Journal of Endovascular Therapy.
The publication highlights practical experience with the Tack Endovascular Systemâ following its European launch in January 2019. The first-of-its kind dissection repair device was implanted in patients who underwent balloon angioplasty as part of endovascular revascularization for peripheral arterial disease or critical limb ischemia and subsequently experienced post-angioplasty dissection. A total of 63 dissections were evenly distributed above and below the knee and exhibited characteristics representative of real-world clinical applications. Tack implants were deployed to treat 95.2% of these dissections, using the above-the-knee (ATK) system for femoropopliteal dissections and the below-the-knee (BTK) system for infrapopliteal dissections.
“With a 98.3% technical success rate, this study demonstrates the practical application of the Tack implants in real-world lesions, completely resolving 59 of 60 dissections with no major adverse events and no device-related complications during the procedure,” commented Dr. Michael K.W. Lichtenberg, Chief of Angiology Clinic and Venous Center, Klinikum Arnsberg in Germany, and lead author of the article. “I am pleased with our experience using the Tack System, including cases with complex lesions. This technology is extremely impressive, and I look forward to continued use in my above- and below-the-knee treatment algorithms.”
Established endovascular revascularization methods, including plain and drug-coated balloon angioplasty, atherectomy and lithotripsy, frequently result in arterial dissections. Often overlooked, underdiagnosed and left untreated, these dissections can lead to acute procedural complications or restenosis, requiring reintervention and potentially limiting future treatment options.1
“We are very pleased to have the results of this clinical investigation published in the Journal of Endovascular Therapy,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “Under challenging real-world conditions, the Tack implants performed as designed. These data further validate use of this novel technology, across all lower extremity vascular beds, to resolve dissections without complications and to improve outcomes of standard endovascular procedures.”
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 devices for above-the-knee (ATK) interventions, or four for below-the-knee (BTK) 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 also 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.
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
1Armstrong 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 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.