Sam Brusco, Associate Editor06.13.22
Philips released the latest results from its Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial, which assessed whether the Tack (4F) endovascular system provides sustained treatment effect and positive impact on critical limb ischemia (CLI) patients’ quality of life out to three years of follow-up.
The TOBA II BTK trial studied post-angioplasty repair using the Philips Tack endovascular system in CLI and infrapopliteal disease patients. The specialized implantable device aims to optimize dissection in CLI patients.
Endpoints included rates of major adverse events, target lesion revascularization (TLR), target limb salvage (TLS) and quality of life (QoL) metrics.
“Based on 36-month follow-up in the TOBA II BTK trial, which is following 233 patients at 41 sites internationally, the Tack endovascular system offers a new standard in repairing below-the-knee arterial dissections,” said co-principal investigator George Adams, M.D., director of cardiovascular and peripheral vascular research at UNC Rex Hospital, and clinical associate professor of medicine at the University of North Carolina at Chapel Hill, who presented the results at the New Cardiovascular Horizons (NCVH) conference in New Orleans on June 2.
Adams added, “The device stands to significantly benefit patients with CLI whose treatment with balloon angioplasty often leads to this particular complication, which typically goes untreated and unaddressed, to the detriment of long-term clinical outcomes.”
The three-year analysis results include the following insights on the Tack endovascular system:
“In treating peripheral arterial disease below the knee with balloon angioplasty, dissections of the popliteal, tibial, and peroneal arteries occur with considerable frequency,” explained Chris Landon, business leader of Image Guided Therapy Devices at Philips. “With the Tack endovascular system from Philips, interventionists can reliably repair below-the-knee arterial dissections—and in doing so, improve major amputation rates and quality of life.”
The TOBA II BTK trial studied post-angioplasty repair using the Philips Tack endovascular system in CLI and infrapopliteal disease patients. The specialized implantable device aims to optimize dissection in CLI patients.
Endpoints included rates of major adverse events, target lesion revascularization (TLR), target limb salvage (TLS) and quality of life (QoL) metrics.
“Based on 36-month follow-up in the TOBA II BTK trial, which is following 233 patients at 41 sites internationally, the Tack endovascular system offers a new standard in repairing below-the-knee arterial dissections,” said co-principal investigator George Adams, M.D., director of cardiovascular and peripheral vascular research at UNC Rex Hospital, and clinical associate professor of medicine at the University of North Carolina at Chapel Hill, who presented the results at the New Cardiovascular Horizons (NCVH) conference in New Orleans on June 2.
Adams added, “The device stands to significantly benefit patients with CLI whose treatment with balloon angioplasty often leads to this particular complication, which typically goes untreated and unaddressed, to the detriment of long-term clinical outcomes.”
The three-year analysis results include the following insights on the Tack endovascular system:
- 93.9% target limb salvage in CLI patients at three years
- 69.6% freedom from clinically-driven target lesion revascularization across all patients at three years
- Sustained improvement in established clinical classification systems including the Rutherford clinical category and hemodynamics in ankle- and toe-brachial indices
- Sustained improvement in patient-reported QoL, mobility measures
“In treating peripheral arterial disease below the knee with balloon angioplasty, dissections of the popliteal, tibial, and peroneal arteries occur with considerable frequency,” explained Chris Landon, business leader of Image Guided Therapy Devices at Philips. “With the Tack endovascular system from Philips, interventionists can reliably repair below-the-knee arterial dissections—and in doing so, improve major amputation rates and quality of life.”