Intact Vascular announced the positive one-year results from its Tack optimised balloon angioplasty (TOBA) II BTK clinical trial during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial Livestream.
Co-principal investigator Patrick Geraghty, professor of Surgery and Radiology at the Washington University School of Medicine in St Louis, USA, 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 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 US Food and Drug (FDA) premarket approval for below-the-knee (BTK) interventions, Tack implants impressively demonstrated an 81.3% Kaplan-Meier tacked segment patency and a 78.6% Kaplan-Meier target lesion patency, with an 83.1% Kaplan-Meier freedom from clinically-driven reintervention at one-year. No fractures, embolisation, or migration of the Tack device were observed, confirming the durability of the minimal metal implants.
Additionally, in the critical limb ischaemia (CLI) cohort, a population associated with high rates of amputation and mortality, Tack implants demonstrated remarkable 96.1% Kaplan-Meier target limb salvage and 89% 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, 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, director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital, in Raleigh, USA, and Andrej Schmidt, Division of Interventional Angiology, University Hospital Leipzig, 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 ischaemia.”