Intact Vascular to Sponsor Post-Angioplasty Dissection Symposium and Present an Update on the TOBA II Pivotal Study Results at the 2018 VEITH Conference

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 during a lunch symposium co-sponsored with Philips at the 45th annual VEITH conference in New York City on Thursday, November 15th. Following the symposium, an update on the company’s TOBA II pivotal trial will be presented.

Intact Vascular’s Tack Endovascular System®, a first-of-its-kind dissection repair device, is designed to preserve vessel integrity and enhance blood flow following balloon angioplasty. Patients with peripheral arterial disease (PAD) who are treated with balloon angioplasty often suffer from dissections or tears that are frequently overlooked, undiagnosed and untreated. These dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures. Research has shown that intravascular ultrasound (IVUS) helps to visualize these dissections, confirming their presence and severity, often not visualized on traditional angiography1.

“The clinical impact of post-angioplasty dissections, although often under-diagnosed and under-estimated, is in fact substantial and can lead to high rates of restenosis and re-intervention,” said Bruce Shook, President and CEO of Intact Vascular. “Our symposium highlights the importance of IVUS to assist in the diagnosis of dissections and the clinical significance of the Tack Endovascular System to minimize further complications and improve the frequently painful, debilitating symptoms for these patients.”

The co-sponsored lunch symposium, “Leave no dissection behind; improve what you see, repair with precision”, will be held from 12:30-1:30PM in the Gramercy Suite West, New York Hilton Midtown and will include the following presentations:

  • Dissections matter and they matter even more in the DCB era: Evidence above and below the knee - presented by Ehrin Armstrong, MD
  • iDissection: using IVUS to see what we are missing: iDissection classification system using intravascular imaging - presented by Nicolas Shammas, MD
  • Tack optimized angioplasty: results from TOBA II: Twelve-month pivotal trial results - presented by William Gray, MD
  • Precision dissection repair: European experience with the Tack Endovascular System® - presented by Michael Lichtenberg, MD

Following the lunch symposium, Dr. Marianne Brodmann from the Medical University of Graz in Austria, will present Update on the Value of Tack Assisted Balloon Angioplasty: Results of the TOBA II Study: Do the Tacks Improve PTA Patency In The Femoropopliteal Segment? from 2:40-2:45PM in the Grand Ballroom West, 3rd Floor.

The Tack Endovascular System will be on display at Intact Vascular’s exhibitor booth, #215.

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 stents2. Additionally, the Tack Endovascular System offers low radial force, designed to 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. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients. 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.

Visit http://www.intactvascular.com/clinical-trials/current-clinical-trials/ for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease and critical limb ischemia.

This press release contains “forward-looking statements” concerning the development of Intact Vascular's products, the potential benefits and attributes of such products and technologies with which its products can be used, 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.

1Shammas, NW, Torey, JT, Shammas, WJ, et al. Intravascular Ultrasound Assessment and Correlation With Angiographic Findings Demonstrating Femoropopliteal Arterial Dissections Post Atherectomy: Results From the iDissection Study. J Invas Cardio 2018; 30:240-244.

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.

“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.

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