Intact Vascular has received US Food and Drug Administration (FDA) approval for the Tack Endovascular System (4F), a novel, minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries.
Regulatory approval was based on data from Intact Vascular’s Tack Optimised Balloon Angioplasty II BTK (TOBA II BTK) clinical trial, the first study to enrol patients with advanced disease below-the-knee and with 100% dissected vessels. The TOBA II BTK study enrolled patients suffering from critical limb-threatening ischemia (CLTI), a condition associated with high rates of amputation and mortality. Data from the trial were presented in a late-breaking scientific session at the 2019 Vascular and Interventional Advances conference (VIVA; 4–7 November 2019, Las Vegas, USA).
“Patients who have progressed to a CLTI diagnosis frequently endure debilitating pain, even at rest, infected foot ulcers, and are at an increased risk for amputation,” comments George Adams (UNC Rex Hospital, Raleigh, USA), co-principal investigator of the TOBA II BTK trial. “This is a complex patient population that historically had limited treatment options. The Tack implants deliver a much-needed solution that effectively restores blood flow, promotes healing, and preserves limbs.”
The prospective, multicentre, single-arm TOBA II BTK study met all primary endpoints with 100% acute dissection resolution and 73.8% of wounds healed or improved at six months. Results demonstrated 95.7% Kaplan-Meier amputation-free survival, 87.3% Kaplan-Meier target lesion patency with significant improvement in toe-brachial index, and 92% Kaplan-Meier freedom from clinically-driven reintervention.