Amsterdam-based Royal Philips designed Tack to provide a sustained treatment effect and positive impact on quality of life for patients with critical limb ischemia (CLI), a severe stage of peripheral arterial disease. It is a minimal-metal dissection repair device for prevision treatment of post-PTA peripheral arterial dissections.
The TOBA II BTK trial studied the safety and efficacy of post-angioplasty dissection repair using Tack. Endpoints of the trial included rates of major adverse events, target lesion revascularization, target limb salvage and quality of life metrics.
“Based on 36-month follow-up in the TOBA II BTK trial, which is following 233 patients at 41 sites internationally, the Tack endovascular system offers a new standard in repairing below-the-knee arterial dissections,” said co-principal investigator George Adams, M.D., director of cardiovascular and peripheral vascular research at UNC Rex Hospital in Raleigh, N.C., and clinical associate professor of medicine at the University of North Carolina at Chapel Hill.
Adams, who presented the results at the New Cardiovascular Horizons (NCVH) conference, said that the device could significantly benefit patients with CLI whose treatment with balloon angioplasty could be at risk of complications.
A three-year analysis of TOBA II included clinical insights on Philips’ Tack endovascular system that showed 93.9% target limb salvage in CLI patients at three years, 69.6% freedom from clinically-driven target lesion revascularization across all patients at three years, sustained improvement in established clinical classification systems including the Rutherford clinical category and hemodynamics in ankle- and toe-brachial indices and sustained improvement in patient-reported quality-of-life and mobility measures.
“In treating peripheral arterial disease below the knee with balloon angioplasty, dissections of the popliteal, tibial and peroneal arteries occur with considerable frequency,” Chris Landon, business leader of image-guided therapy devices at Philips, said in a news release. “With the Tack endovascular system from Philips, interventionists can reliably repair below-the-knee arterial dissections – and in doing so, improve major amputation rates and quality of life.”