Royal Philips today announced the latest results from the Tack optimised balloon angioplasty (TOBA) II below-the-knee (BTK) clinical trial, demonstrating that the Philips endovascular system—Tack (4F)—provides a sustained treatment effect and positive impact on quality of life for patients with chronic limb-threatening ischaemia (CLTI) out to three years of clinical follow-up. The Tack 4F is the first and only device of its kind approved by the US Food and Drug Administration (FDA), according to a company press release.
The TOBA II BTK trial studied the safety and efficacy of post-angioplasty dissection repair using the Philips Tack endovascular system in patients with CLTI and infrapopliteal disease. Philips details that the Tack endovascular system is a unique specialised implantable device to optimise the treatment of dissections in patients with CLTI. Endpoints included rates of major adverse events, target lesion revascularisation (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 (UNC Rex Hospital, Raleigh, USA), who presented the results at the New Cardiovascular Horizons (NCVH) conference (31 May–3 June, New Orleans, USA).
Adams added: “The device stands to significantly benefit patients with CLTI 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 of TOBA II BTK results includes the following clinical insights on the Tack endovascular system:
- 93.9% target limb salvage in CLTI patients at three years
- 69.6% freedom from clinically-driven target lesion revascularisation across all patients at three years
- Sustained improvement in established clinical classification systems including the Rutherford clinical category and haemodynamics in ankle- and toe-brachial indices
- Sustained improvement in patient-reported quality-of-life and 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.”
Philips has previously reported data from the TOBA II and III studies, which evaluated the Tack endovascular system for superficial femoral and proximal popliteal artery dissection repair following uncoated balloon angioplasty and/or drug-coated balloon (DCB) angioplasty. These multicentre, global and European studies demonstrated that the use of the Tack endovascular system resulted in dissection resolution following uncoated or DCB angioplasty.
- In TOBA II, which involved uncoated and drug-coated balloons, dissection repair with the Tack System resulted in 89.6% and 86.5% 12-month primary patency (uncoated balloon group) and freedom from CD-TLR
- In TOBA III, which involved drug-coated balloons, dissection repair with the Tack endovascular system resulted in 95.0% and 97.5% 12-month primary patency and freedom from CD-TLR
There were no major adverse events reported through 30 days in either study.
Together, the TOBA II, TOBA III and TOBA II BTK trials support the safety and efficacy of the Tack endovascular system for post-PTA dissection repair in above- and below-the-knee arterial disease. According to Philips, the 36-month TOBA II BTK data reported at NCVH adds to the “robust” body of clinical evidence supporting the safety and effectiveness of the Tack Endovascular System in both vessel beds.
Philips Tack endovascular system is currently available for sale in the USA and some EU countries. Further information, including safety information, is available here.