Royal Philips has reported positive two-year data from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial of its dissection repair device, Tack Endovascular System (4F).
The system is specially designed to deliver accurate treatment of peripheral arterial dissections after balloon angioplasty in above- or below-the-knee therapeutic procedures.
This minimal-metal implant could reduce vessel inflammation, aid in healing, enhance outcomes, preserve further treatment options for peripheral artery disease (PAD) and critical limb ischemia (CLI) patients and limbs.
It is said to be the only vascular implant to obtain the US Food and Drug Administration’s (FDA) pre-market approval for BTK interventions, Philips noted.
Trial data showed that the implantable system offered a continued treatment effect and progressive impact on quality of life in PAD and CLI patients at two years.
CLI is an advanced form of PAD that arises when a block in an artery severely lowers blood flow, leading to painful lesions, debilitating rest pain, ulcers and life-threatening infection. Without treatment, 50% of CLI patients will need an amputation or die within the first year.
All the trial subjects showed 73.6% freedom from clinically-driven target lesion revascularisation (CD-TLR) and did not need another surgery for the treated artery part at two years.
CD-TLR is a treatment efficacy durability indicator.
Furthermore, 94.7% target limb salvage or freedom from major amputation was noted in more complex CLI subjects.
Sustained progress in the quality of life of the subjects who were implanted with this dissection repair device was noted.
Philips image guided therapy devices senior vice-president and general manager Chris Landon said: “This new data further demonstrates the value of the Tack Endovascular System for repairing dissections and optimising post-angioplasty outcomes in a challenging patient population.
“Dissection repair following balloon angioplasty has a positive, long-term value for both clinicians and patients alike.”
In April, the FDA granted 510(k) clearance to Philips’ SmartCT image acquisition, visualisation and measurement software.