WAYNE, Pa.--(BUSINESS WIRE)--Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the peer-reviewed publication of its Tack Optimized Balloon Angioplasty (TOBA) III 12-month clinical trial results in the Journal of Vascular Surgery. The multi-center, single-arm, prospective study investigated the combination of the Tack Endovascular System with Medtronic’s IN.PACT ™ Admiral ™ drug-coated balloon as a treatment in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA). The trial results were previously presented as part of the High Impact Clinical Research session during the 2019 Transcatheter Cardiovascular Therapeutics (TCT) conference.
“We are thrilled to have the TOBA III data published in the Journal of Vascular Surgery,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “This peer-reviewed article adds to the strong body of evidence supporting use of the Tack Endovascular System for focal dissection repair when treating lesions both above- and below-the-knee.”
The study was conducted in multiple sites across Europe and enrolled 201 patients, including 169 patients with arterial lesions ≤150 mm in length and a subset of 32 patients with long arterial lesions (>150 and ≤250 mm). All patients suffered from peripheral arterial disease (PAD) and underwent drug-coated balloon angioplasty, consequently experiencing at least one dissection requiring repair. Results from the 169-patient standard lesion cohort (≤150mm) impressively demonstrated a 95% primary K-M patency with 97.5% K-M freedom from clinically-driven reintervention at 12-months and a 0.6% bailout stent rate.
The observational data from the long lesion subset (>150 and ≤250mm) was analyzed separately. Results from these 32 patients notably demonstrated 98.8% complete dissection resolution and 89.3% K-M vessel patency, with 96.8% K-M freedom from clinically-driven reintervention at 12-months and a 0% bailout stent rate.
“The TOBA III trial met all primary endpoints and impressively demonstrated the highest reported rates of safety, patency and freedom from clinically driven reintervention when treating above-the-knee lesions,” commented Marianne Brodmann, M.D., Head of the Clinical Division of Angiology, Medical University of Graz, Austria and Principal Investigator of the TOBA III trial. “This study is unique in that we enrolled patients with 100% dissected vessels and included a long lesion subset, notoriously a complex cohort. These clinically compelling data further validate Tack implants as safe and effective for PAD interventions.”
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 significantly less metal than stents. 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. Intact Vascular recently announced FDA approval of the Tack Endovascular System (4F), the first vascular implant approved for below-the-knee post-angioplasty dissection repair. With prior FDA approval granted for the Tack Endovascular System (6F) along with CE Mark Authorization, the company plans to progress toward broader market commercialization for both above- and below-the-knee interventions.
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 or the BD Interventional Lutonix® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK has 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 the inclusion in the study of 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, the company’s commercialization plans 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.
Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of BD Interventional.
IN.PACTTM and AdmiralTM are trademarks of Medtronic, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
The Tack Endovascular System (6F, 3.5-6.0mm and 4.0-8.0mm) is intended for use in the superficial femoral and proximal popliteal arteries, ranging from 3.5mm to 6.0mm and 4.0mm to 8.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
The Tack Endovascular System (4F, 1.5-4.5mm) is intended for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5mm to 4.5mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
