The TOBA II BTK trial studied the safety and efficacy of post-angioplasty dissection repair utilising the Philips Tack (4F) endovascular system in patients with CLI and infrapopliteal illness
Royal Philips has announced positive results from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial of the company’s Tack (4F) endovascular system.
Philips endovascular system Tack (4F) is said to be the first and only device of its kind approved by the US Food and Drug Administration (FDA)
The TOBA II BTK trial studied the safety and efficacy of post-angioplasty dissection repair utilising the Philips Tack (4F) endovascular system in patients with CLI and infrapopliteal illness.
According to the firm, the device had a positive impact on the quality of life for patients with critical limb ischemia (CLI), a stage of peripheral arterial disease (PAD), out to three years of clinical follow-up.
The Tack endovascular system is a specialised implantable device that helps patients with CLI treat dissections more effectively.
Endpoints included rates of major adverse events, target lesion revascularization (TLR), target limb salvage (TLS) and quality of life (QoL) metrics.
Philips said that there were no major adverse events reported through 30 days in either study.
George Adams, MD, co-principal investigator of TOBA II BTK, presented the study results at the 2022 New Cardiovascular Horizons (NCVH) annual conference held from 31 May to 3 June in New Orleans, Louisiana.
Adams said: “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.
“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 analysis of TOBA II BTK study results included 93.9% TLS in CLI patients at three years, 69.6% freedom from clinically driven TLR across all patients at three years, sustained improvement in established clinical classification systems and sustained improvement in patient-reported QoL and mobility measures.
Philips Image Guided Therapy Devices business leader Chris Landon said: “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.
“In treating peripheral arterial disease below the knee with balloon angioplasty, dissections of the popliteal, tibial and peroneal arteries occur with considerable frequency.
“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 Philips Tack endovascular system is currently on the market in the US and a few European nations.
The device is part of the company’s peripheral vascular portfolio, which also includes advanced interventional imaging systems for precision guidance Azurion, intravascular ultrasound (IVUS) catheters, peripheral atherectomy devices, Philips’ Stellarex drug-coated balloon, etc.