Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced at the 15th annual VIVA conference in Las Vegas that its Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial successfully achieved both primary and secondary endpoints. One year results from the TOBA II study were presented in the late-breaking scientific session by William Gray, M.D., System Chief, Division of Cardiovascular Disease at Main Line Health, President, Lankenau Heart Institute and Principal Investigator for the TOBA II trial.
Notably the first peripheral vascular study to enroll patients with 100% dissected vessels, the TOBA II study, was conducted at 33 U.S. and European sites to investigate the Tack Endovascular System for the repair of post-angioplasty dissections in femoropopliteal arteries. All patients enrolled (n=213) suffered from peripheral arterial disease (PAD), underwent balloon angioplasty with either plain or drug-coated balloons, and consequently experienced at least one dissection, with 69.4% being classified as severe.
Impressive results presented from this first-of-its-kind study demonstrated 92.1% complete dissection resolution within a clinically challenging patient population, along with 79.3% K-M vessel patency and 86.5% K-M freedom from clinically driven reintervention at 12-months. Additionally, the TOBA II study validated the Tack implants as stable and durable, with zero implant fractures, 99.9% freedom from migration, and a 0.5% bailout stent rate.
The TOBA II study is unique in that it is the first large scale pivotal evaluation in peripheral arterial vessels that are 100% dissected following initial angioplasty and treated with a precisely targeted implant, commented Dr. William Gray. This study introduces a new therapeutic paradigm, demonstrating that we can repair dissected arteries, leaving minimal metal behind to preserve future treatment options for our patients, and producing excellent 12-month outcomes.
As presented today, the TOBA II data further augment the growing body of evidence supporting the idea that a purpose-built implant for dissection repair can enhance the clinical results of balloon angioplasty, said Bruce Shook, Intact Vasculars President and CEO. The Tack Endovascular System is also well aligned with a primary goal of endovascular operators: to leave as little metal behind as possible.
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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 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.
This press release contains forward-looking statements concerning the development of Intact Vascular’s products, the benefits and attributes of such products, and the companys 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.
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048