WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the one-year data from its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial will be presented during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial event by Co-Principal Investigator, Patrick Geraghty, M.D., Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri. The Late-Breaking Clinical Trials livestream will be held on Thursday, June 25th at 7:30 pm ET.
The recently FDA-approved Tack Endovascular System® (4F) was studied in the TOBA II BTK trial, notably the first U.S. IDE clinical study approved to investigate the safety and effectiveness of a permanent vascular implant for below-the-knee (BTK) post-angioplasty dissection repair. The single-arm prospective study enrolled 233 patients at 41 sites in the U.S., Europe and New Zealand, the majority of which suffered from critical limb ischemia (CLI). All patients enrolled underwent standard balloon angioplasty and consequently experienced at least one dissection that required repair.
“We are honored to be one of the trials selected for VIVA’s Late-Breaking Clinical Trial livestream,” commented Bruce Shook, President and CEO of Intact Vascular. “The one-year TOBA II BTK data provide important evidence supporting the Tack implant’s sustained durability and will reinforce its importance as the only FDA-approved implant that, in combination with balloon angioplasty, preserves limbs in this challenging patient population.”
To register for the upcoming VIVA Late-Breaking Clinical Trials livestream, please visit vivaphysicians.org.
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 products and 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 registered trademarks of Medtronic, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
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 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048