January 27, 2020 WAYNE, Pa.–(BUSINESS WIRE)– Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the schedule of presentations to be featured at the annual Leipzig Interventional Course (LINC) in Leipzig, Germany on Tuesday, January 28th and Wednesday, January 29th.
The series of podium presentations will highlight clinical and commercial use of the Tack Endovascular System®, a first-of-its-kind treatment for repairing post-angioplasty dissections. The minimal-metal implant portfolio will be on display at Intact Vascular’s booth, #41.
Currently, the 6F Tack® implants are commercially available in the U.S. and Europe for use in superficial femoral and proximal popliteal arteries. The 4F system is CE Marked and launched in Europe in early 2019. Designed for dissections in below-the-knee interventions, the 4F system is pending FDA approval in the U.S. following the Tack Optimized Balloon Angioplasty II BTK (TOBA II BTK) pivotal trial, notably the first study to enroll patients with advanced below-the-knee disease and 100% dissected vessels. Data from the trial was recently presented in a late-breaking scientific session at the 2019 VIVA conference.
“We are both honored and pleased to be presenting again this year at LINC. The conference leadership team has selected a robust podium program that highlights the recent clinical data and real-world experience using Tack implants,” remarked Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “We look forward to presenting data that supports the important treatment paradigm of dissection repair, in arteries above and below-the-knee, to improve outcomes for patients undergoing endovascular interventions.”
The following sessions will be presented in Room 1, Main Arena 1 on Tuesday, January 28th:
10:47 – 10:52: Post-DCB Dissection Repair: 12-Month Results from TOBA III, presented by Christian Wissgott, MD
17:32 – 17:37: A Single-Center Experience with the Tack Endovascular System: Real-world Tacking Above and Below-the-Knee, presented by Michael K.W. Lichtenberg, MD
17:37 – 17:42: Dissecting the TOBA Data Above and Below-the-Knee: What it Means in Practice, presented by William Gray, MD
The following sessions will be presented in Room 1, Main Arena 1 on Wednesday, January 29th:
8:55 – 9:00: Optimizing Below-the-Knee Angioplasty: Dissections Matter, presented by Andrew Holden, MD
9:00 – 9:05: Repairing BTK Dissections: Results from the TOBA II BTK Pivotal Study, presented by George Adams, MD
Additionally, the following session will be presented in the Global Expert Exchange Forum (Room 5):
9:05 – 9:10: Dissections: Do They Matter and How Can They be Managed? presented by Thomas Zeller, MD
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) is intended for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 3.5mm to 6.0mm 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.