First Pivotal Study to Investigate Permanent Vascular Implant as a Treatment for Post-Angioplasty Dissections in Arteries Below the Knee (BTK)
October 22, 2019 – WAYNE, Pa.–(BUSINESS WIRE)– Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that the six-month data from its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial will be presented during the Late-Breaking Clinical Trial session at the 16th Annual VIVA Conference, November 4-7th in Las Vegas, Nevada.
The TOBA II BTK study is notably the first U.S. IDE clinical study approved to investigate the safety and effectiveness of a permanent implant to repair dissections in BTK arteries. The single-arm prospective study enrolled 233 patients at 41 sites in the U.S., Europe and New Zealand. The majority of patients enrolled suffered from critical limb ischemia (CLI), underwent standard balloon angioplasty and consequently experienced at least one dissection that required repair with the Tack Endovascular System®.
George Adams, M.D., M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital, Raleigh, North Carolina and Co-Principal Investigator of the TOBA II BTK trial, will present the six-month data on Tuesday, November 6th at 9:15 am PST in the Global Theater/Lafite Ballroom of the Wynn Las Vegas hotel.
“We are very pleased to have the TOBA II BTK data presented as a Late-Breaking session at this year’s VIVA meeting, underscoring the clinical importance of this first-of-its-kind trial,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “We look forward to sharing the positive findings of the Tack System and ultimately providing the first permanent implant solution for patients suffering from below-the-knee arterial disease.”
Additional presentations of interest related to the Tack Endovascular System are listed below in Pacific Time.
Monday, November 4th
10:40am- CLI PreCourse: When and How to Manage Dissections: Prolonged PTA, Tacks, and Stents, George Adams, MD
Wednesday, November 6th
8:35am- LINC @ VIVA: Strategies for Optimizing Acute Results of BTK Intervention: Balloon Sizing, Best Minimal Lumen Diameter, Managing Dissections, and More, Marianne Brodmann, MD
3:04pm- LINC @ VIVA: Tack-Optimized Angioplasty in the Tibial Arteries: Technique and Results, Ehrin Armstrong, MD
Thursday, November 7th
7:05am- Tibial Scaffolds, Dierk Scheinert, MD
7:19am- Dissection Repair, John Rundback, MD
1:37pm- How to Manage Recoil and Dissections After BTK DCB, John Rundback, 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.
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® 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.