Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced positive two-year results from the Tack Optimized Balloon Angioplasty (TOBA) 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 Artery Disease (PAD) and Critical Limb Ischemia (CLI) patients at two years. The data was presented by Co-Principal Investigator George Adams, MD, Interventional Cardiologist at Rex Hospital affiliated with the University of North Carolina at Chapel Hill, at the 2021 New Cardiovascular Horizons (NCVH) conference (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 CLI 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).