Royal Philips recently announced positive two-year results from the TOBA (Tack optimized balloon angioplasty) II below-the-knee (BTK) clinical trial.
The data show the Philips Tack endovascular system (4F), a first-of-its kind dissection repair device, provides a sustained treatment effect and positive impact on quality of life for peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI) patients at two years. George Adams, MD, associate professor of cardiology at Rex Hospital in Chapel Hill, North Carolina, co-principal investigator, presented the findings at the 2021 New Cardiovascular Horizons (NCVH) conference (New Orleans, June 1–4).
Across all patients in the TOBA II BTK clinical trial at two years, 73.6% had freedom from clinically-driven target lesion revascularization (CD-TLR) and did not require a repeat procedure for the treated artery segment. CD-TLR is a commonly used indicator of treatment efficacy durability. In the more complex CLTI patient population, which is typically associated with high rates of amputation and mortality, the data showed 94.7% target limb salvage (freedom from major amputation).