Royal Philips, a global leader in health technology, today announced the latest results from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial, demonstrating that the Philips endovascular system – Tack (4F) – the first and only device of its kind approved by the U.S. Food and Drug Administration (FDA), provides a sustained treatment effect and positive impact on quality of life for patients with critical limb ischemia (CLI), a severe stage of peripheral arterial disease (PAD), out to three years of clinical follow-up.

The TOBA II BTK trial studied the safety and efficacy of post-angioplasty dissection repair using the Philips Tack endovascular system in patients with CLI and infrapopliteal disease. The Tack endovascular system is a unique specialized implantable device to optimize the treatment of dissections in patients with CLI. 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 in Raleigh, N.C., and clinical associate professor of medicine at the University of North Carolina at Chapel Hill, who presented the results to hundreds of interventional cardiologists, interventional radiologists and vascular surgeons at the New Cardiovascular Horizons (NCVH) conference in New Orleans, USA, 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.”

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, said Chris Landon, Business Leader of Image Guided Therapy Devices at Philips.  

“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.”