Royal Philips recently announced positive two-year results from the TOBA (Tack optimised 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 ischaemia (CLTI) patients at two years. George Adams (Rex Hospital, Chapel Hill, USA), co-principal investigator, presented the findings at the 2021 New Cardiovascular Horizons (NCVH) conference (1–4 June, New Orleans, USA).
Across all patients in the TOBA II BTK clinical trial at two years, 73.6% had freedom from clinically-driven target lesion revascularisation (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).