Intact Vascular Announces Positive One-Year Data from TOBA II BTK Clinical Trial in VIVA Late-Breaking Session
Durable Below-the-Knee Vascular Implant for Post-Angioplasty Dissection Repair Demonstrates Sustained Success Saving Limbs
WAYNE, Pa.-- Intact Vascular Inc.,a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the positive one-year results from its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial livestream.
Co-Principal Investigator, Patrick Geraghty, M.D., Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri, presented the one-year results, which successfully demonstrated sustained improvement in Rutherford category, toe-brachial index (TBI) and quality-of-life metrics following management of patients with post-PTA dissection with the Tack Endovascular System® (4F), in conjunction with excellent limb salvage and amputation free survival rates.
“Effective treatment of below-the-knee arterial disease is a critical component of amputation prevention. Now, with Tack implants, we have an on-label treatment for post-angioplasty dissection that provides excellent outcomes through the first year of follow-up,” commented Dr. Geraghty. “The Tack device is a valuable treatment option that augments an aggressive approach to endovascular limb salvage.”
Notably the first vascular implant to receive U.S. Food and Drug (FDA) pre-market approval for below-the-knee (BTK) interventions, Tack® implants impressively demonstrated an 81.3% K-M Tacked Segment Patency and a 78.6% K-M Target Lesion Patency, with an 83.1% K-M Freedom from Clinically-Driven Reintervention at one-year. No fractures, embolization or migration of the Tack device were observed, confirming the durability of the minimal metal implants.
Additionally, in the critical limb ischemia (CLI) cohort, a population associated with high rates of amputation and mortality, Tack implants demonstrated remarkable 96.1% K-M Target Limb Salvage and 89.0% Amputation-Free Survival.
“This unprecedented trial is the first to investigate the safety and efficacy of a permanent vascular implant for repairing dissections in arteries below-the-knee. It enrolled a complex, predominantly CLI patient population that included 100% dissected vessels,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “These excellent one-year data highlight the clinical importance of below-the-knee dissection repair and validate the sustained durability of Tack implants.”
Additional Co-Principal Investigators for the trial included George Adams, M.D., M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital, in Raleigh, North Carolina, and Andrej Schmidt, M.D., Division of Interventional Angiology, University Hospital Leipzig, Germany.
“We are extremely pleased with the results from TOBA II BTK,” commented Bruce Shook, President and CEO of Intact Vascular. “The data from this clinical study add to the expanding evidence that repairing dissections following angioplasty improves long term outcomes for patients suffering from peripheral arterial disease (PAD). With FDA approval in hand, we are moving forward to address the large unmet need that exists among patients suffering from the most serious form of this disease, critical limb ischemia. We are confident that the long-term data presented today will further accelerate adoption of this unique device, and we look forward to continued commercial expansion of this first-of-its-kind technology.”
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.
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 and commercialization of Intact Vascular's products, the benefits and attributes of such products 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).