Amsterdam-based Philips presented data from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial at the 2021 New Cardiovascular Horizons Conference, according to a news release.
Data presented by co-principal investigator Dr. George Adams, an interventional cardiologist at Rex Hospital (University of North Carolina, Chapel Hill), demonstrated a sustained treatment effect and a positive impact on quality of life for patients with peripheral artery disease (PAD) and critical limb ischemia (CLI) treated with the Tack dissection repair device, which Philips acquired when it bought Intact Vascular for $275 million in August 2020.
Tack is meant to repair peripheral arterial dissections following balloon angioplasty. The idea is to optimize the treatment of dissections in patients with PAD and CLI. The study found that Tack provided 73.6% of patients freedom from clinically-driven target lesion revascularization at two years, with no requirement for a repeat procedure for the treated artery segment in that chunk of patients.
In the CLI patient population, which proves to be more complex and typically associated with high rates of amputation and mortality, data showed 94.7% target limb salvage.
“The global endovascular community is diligently working to better understand how to restore blood flow in small limb vessels, promote healing and ultimately preserve limbs for people with CLI, one of the most vulnerable and critical patient populations,” Adams said in the release. “These positive two-year data reiterate the clinical importance of below-the-knee dissection repair and validates the sustained durability of Tack-optimized interventions.”
Philips SVP & GM of image-guided therapies Chris Landon thought the new data further demonstrates the value of the Tack endovascular system for repairing dissections and optimizing post-angioplasty outcomes in what he described as a challenging patient population. “Dissection repair following balloon angioplasty has a positive, long-term value for both clinicians and patients alike. The implant is an important part of our complete procedural solutions to improve existing procedures and expand treatment options for PAD and CLI patients.”
