WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a private medical device company committed to developing solutions for minimally invasive peripheral vascular procedures, today announced the schedule of key presentations to be featured at the annual Leipzig Interventional Course (LINC) in Leipzig, Germany on Tuesday, January 22nd and Wednesday, January 23rd.
Intact Vascular’s Tack Endovascular System® is a first-of-its-kind dissection repair device implanted following post-angioplasty dissections in patients with peripheral arterial disease (PAD) and critical limb ischemia (CLI). Patients often suffer from dissections that are frequently overlooked, undiagnosed and untreated. If untreated, these dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures.
“We are pleased that the topic of post-angioplasty dissections is prominently highlighted this year at the LINC meeting,” stated Bruce Shook, President and CEO of Intact Vascular. “We are excited to share the robust clinical program for Intact’s Tack Endovascular System and demonstrate how our technology improves outcomes for patients.”
The following sessions will be presented on Tuesday, January 22nd:
1:00 – 1:05 (Main Arena – Room 1): TOBA II Trial: 1-Year Results, presented by William Gray, MD
1:35 – 1:40 (Technical Forum – Room 3): Dissecting the TOBA Data: What Does it Mean in Practice, presented by Peter Schneider, MD
Additionally, the following sessions will be presented on Wednesday, January 23rd in the Global Expert Exchange Forum (Room 5):
11:20 – 11:25: Dissections Matter: Evidence for Post-PTA Dissections, presented by Ehrin Armstrong, MD
11:25 – 11:30: Dissection Identification and Classification Using IVUS, presented by Nicolas Shammas, MD
11:30 – 11:35: How I Will Use the Tack Endovascular System®in the Real World, presented by Michael Lichtenberg, MD
Visit the Intact Vascular booth, #41, to learn more about the Tack Endovascular System.
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 improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Pre-loaded with six self-expanding nitinol devices 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 stents1. Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) 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 BARD Lutonix® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and has recently completed enrollment. TOBA III has completed enrollment in Europe and is investigating the combination of the Tack implant with the Medtronic IN.PACT™ Admiral™ (DCB), inclusive of long lesions.
This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential 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.
“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of C.R.BARD, Inc.
IN.PACT(TM) Admiral(TM) are trademarks of Medtronic, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States.