January 28, 2020
WAYNE, Pa.–(BUSINESS WIRE)– Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced Food and Drug Administration PMA approval for the expansion of its Tack Endovascular System® (6F) portfolio. The new approved device size is indicated for repair of post-angioplasty dissections in superficial femoral and proximal popliteal arteries ranging from 4.0mm to 8.0mm reference vessel diameter (RVD), allowing treatment of a broader range of vessels compared to the current 6F Tack implant offering.
“The Tack System performs exceptionally well when repairing dissections, which are a common occurrence following balloon angioplasty in patients with peripheral arterial disease,” commented Dr. Michael K.W. Lichtenberg, Chief of Angiology Clinic and Venous Center, Klinikum Arnsberg in Germany. “The clinical benefit of Tack implants is clear and proven as demonstrated in multiple clinical trials, peer reviewed publications and real-world experience. I am pleased to have a larger size implant available, giving me even greater flexibility when treating larger SFA vessels.”
Arterial dissections are a frequent consequence of balloon angioplasty and can compromise clinical outcomes, leading to acute thrombosis and occlusions. These complications lower long-term patency rates and result in repeat procedures, limiting future treatment options1. A first-of-its-kind, minimal metal approach for focal dissection repair, the Tack Endovascular System, repairs post-angioplasty dissections to improve outcomes for patients with peripheral arterial disease (PAD) 1.
“Being able to provide the Tack® implant in sizes up to 8.0mm is an important product offering for our customers,” remarked Steve MacKinnon, Vice President of Sales for Intact Vascular. “We are excited to bring a full range of implant sizes to market and further improve outcomes for endovascular interventions.”
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.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 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. To learn more about Intact Vascular’s clinical program, please visit www.intactvascular.com/clinical-studies/.
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
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® (6F and 4F) is CE Mark Authorized under EC Directive 93/42/EEC.
The Tack Endovascular System® (6F, 3.5mm-6.0mm and 4.0mm-8.0mm) is intended for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 3.5mm to 6.0mm and 4.0mm to 8.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
CAUTION: Investigational device. Tack Endovascular System® (4F) is limited by federal (United States) law to investigational use. Tack Endovascular System® (4F) is not available for sale in the United States.