This multi-center, single-arm, prospective study was conducted in Europe and investigated the combination of the Tack Endovascular System with Medtronic’s IN.PACT Admiral drug-coated balloon as a treatment in the superficial femoral (SFA) and/or proximal popliteal (PPA) arteries
Image: Intact Vascular announces positive one-year data from TOBA III clinical trial. Photo: Courtesy of yodiyim/FreeDigitalPhotos.net
Intact Vascular, a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the positive one-year results of its Tack Optimized Balloon Angioplasty (TOBA) III clinical trial, successfully achieving both primary and secondary endpoints. Marianne Brodmann, M.D., Head of the Clinical Division of Angiology, Medical University of Graz, Austria and Principal Investigator of the TOBA III trial, presented the data today during the High Impact Clinical Research session of the 31st Transcatheter Cardiovascular Therapeutics (TCT) meeting, the annual scientific symposium of the Cardiovascular Research Foundation.
This multi-center, single-arm, prospective study was conducted in Europe and investigated the combination of the Tack Endovascular System with Medtronic’s IN.PACT Admiral drug-coated balloon as a treatment in the superficial femoral (SFA) and/or proximal popliteal (PPA) arteries. The study 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 ≤250mm). All patients suffered from peripheral arterial disease (PAD) and underwent balloon angioplasty, consequently experiencing at least one dissection requiring repair.
Results from the 169 patient standard lesion cohort (≤150mm) impressively demonstrated 97.7% complete dissection resolution, 95% K-M vessel patency and 97.5% K-M freedom from clinically driven reintervention at 12-months. This was accomplished with a 0.6% bailout stent rate. These outstanding results add to the large body of clinical evidence supporting the use of the Tack System for post-PTA dissection repair and further demonstrate the long-term effectiveness of the technology.
“I am extremely pleased with the clinically compelling results of the TOBA III study,” commented Dr. Marianne Brodmann. “The Tack System provides a safe and effective solution for treating post-angioplasty dissections. I believe this new therapeutic paradigm will change the standard of care for above-the-knee interventions.”
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 data presented today at TCT further validates the use of Tack implants to improve balloon angioplasty results,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “The data suggest that we have been implanting too much metal for far too long with traditional stents. We are thrilled to offer a minimal metal therapeutic solution that enhances patient outcomes and preserves future treatment options.”
“We would like to thank the excellent team of physicians and coordinators who contributed to the success of the TOBA III study,” stated Bruce Shook, Intact Vascular’s President and CEO. “The results presented today are the most impressive reported to date for balloon angioplasty in above-the-knee arterial disease. We look forward to offering this technology to more patients as we continue the rapid expansion of our commercial efforts.”
Source: Company Press Release