George Adams, MD (Raleigh, USA) talks to Vascular News at VIVA 2019 (Vascular InterVentional Advances; 4–7 November, Las Vegas, USA) about the six-month data from the TOBA II BTK pivotal study immediately after the late-breaking clinical trial session in which these data were presented.
TOBA II BTK examined the safety and efficacy of the Tack Endovascular System (Intact Vascular) when used to repair dissections in the arteries below-the-knee following percutaneous transluminal angioplasty (PTA) as a treatment for critical limb ischaemia (CLI).
Adams explains that placing the 6mm Tack® implant below the knee had “impressive results” in regards to clinically-driven target lesion revascularisation (TLR) and primary patency, and that the data also showed “significant improvements” in Rutherford class and quality of life metrics.
The Tack implant “allows us to heal wounds and heal them faster” so that patients who were functional before the onset of severe disease can “become mobile again”, said Adams, who emphasised some of the outcomes from the study that really mattered to patients.
Adams also outlines why the Tack implant is so well suited to below-the-knee vessels, including that it allows physicians to treat multiple dissections with a single device and that it has a low profile and low radial force which decreases the inflammatory response in the tibial vessels. It also leaves options open for any future revascularisation, he says.
The Tack Endovascular System (4F) received FDA approval in April 2020 for below-the-knee dissection repair.
This video was sponsored by Intact Vascular, Inc.