First-of-its-Kind Pivotal Study of the Tack Endovascular System® Demonstrates 100% Dissection Resolution in Challenging Below-the-Knee Disease
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the positive six-month results of its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial, successfully achieving all primary (P < 0.0001) and secondary endpoints with very low rates of major amputation and all-cause death.
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, presented the 6-month data today during the Late-Breaking Clinical Trial session at the 2019 VIVA Conference. The study focused on patients suffering from critical limb ischema (CLI), a diagnosis associated with high rates of amputation and mortality, that currently effects approximately 3 million patients in the U.S.1,2
“This trial is the first study to enroll patients with advanced below-the-knee disease and 100% dissected vessels,” commented Dr. Adams. “It is very exciting to now have an effective therapeutic option that promotes healing and limb preservation in a complex patient population. With these impressive clinical results, I am confident the Tack implants will significantly improve treatment for below-the-knee arterial disease.”
This prospective, single-arm study was conducted at multiple sites across Europe, New Zealand and the U.S. to investigate the safety and effectiveness of a permanent vascular implant for arteries below the knee. All patients were implanted with the Tack Endovascular System to treat dissections resulting from percutaneous transluminal angioplasty (PTA) in the mid/distal popliteal, tibial and/or peroneal arteries. A total of 341 dissections were treated across the 233 patients enrolled, a particularly challenging population with 65.7% suffering from diabetes, 83.7% baseline Rutherford classification of 4 or 5 and 47.6% with chronic total occlusions (CTO).
The Tack® implants demonstrated 100% acute dissection resolution, with 73.8% of wounds healed or improved at six months. Results at six months demonstrated 95.7% K-M amputation-free survival, 87.3% K-M target lesion patency with significant improvement in toe-brachial index (TBI) and 92.0% K-M freedom from clinically driven reintervention.
“Currently, patients suffering from the painful and debilitating effects of CLI have limited treatment options and are at an increased risk of amputation,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “The data presented today demonstrates that this purpose-built, below-the-knee implant safely and effectively maintains vessel integrity and improves blood flow to enhance outcomes for patients with advanced disease.”
Additional Co-Principal Investigators for the trial included Patrick Geraghty, M.D., Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri, and Andrej Schmidt, M.D., Division of Interventional Angiology, University Hospital Leipzing, Germany.
“We would like to thank the excellent team of physicians and coordinators who contributed to the success of the TOBA II BTK trial,” stated Bruce Shook, Intact Vascular’s President and CEO. “We are very pleased with the results presented today, which will support our PMA application for a below-the-knee indication. Pending FDA approval, we anticipate U.S. commercial launch in the first half of 2020.”
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.3 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.
1The Sage Group. THE SAGE GROUP Releases New Estimates for the United States Prevalence and Incidence of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI). Press release October 25, 2016.
2 Mustapha JA, Katzen BT, Neville RF, et al. Disease burden and clinical outcomes following initial diagnosis of critical limb ischemia in the Medicare population. J Am Coll Cardiol: Cardiovasc Interv 2018;11:1011-1012.
3Bosiers 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.
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048