April 14, 2020
FDA Approves Intact Vascular's Tack Endovascular System for BTK Dissection Repair
April 14, 2020—Intact Vascular, Inc. announced FDA approval of its Tack (4-F) endovascular system for repair of postangioplasty dissections in the mid/distal popliteal, tibial, and/or peroneal below-the-knee (BTK) arteries ranging in diameter from 1.5 to 4.5 mm.
The company stated that regulatory approval was based on data from Intact Vascular’s Tack Optimized Balloon Angioplasty II Below-the-Knee (TOBA II BTK) clinical trial that enrolled patients with critical limb ischemia. The trial was led by coprincipal investigators George Adams, MD; Patrick Geraghty, MD; and Andrej Schmidt, MD.
The prospective, multicenter, single-arm TOBA II BTK trial was composed of patients with advanced BTK disease and 100% dissected vessels. The company reports that the study met all primary endpoints, with 100% acute dissection resolution and 73.8% of wounds healed or improved at 6 months. Results demonstrated 95.7% amputation-free survival, 87.3% target lesion patency with significant improvement in toe-brachial index, and 92% freedom from clinically driven reintervention per Kaplan-Meier estimates.
Dr. Adams presented the 6-month TOBA II BTK trial data during a late-breaking clinical trial session at VIVA in November 2019.
“Patients who have progressed to a CLI diagnosis frequently endure debilitating pain, even at rest, infected foot ulcers, and are at an increased risk for amputation,” commented Dr. Adams in the company's announcement. “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.” Dr. Adams is Director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital in Raleigh, North Carolina.
Dr. Geraghty, who is Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri, added, “The TOBA II BTK trial was very well designed and the first to investigate a permanent vascular implant for treatment of postangioplasty dissections in small vessels. FDA approval of the Tack (4-F) implant marks a significant advancement in treatment of CLI, and I am pleased to have this pioneering technology available going forward.”
In April 2019, the company announced FDA approval for above-the-knee (ATK) interventions. The Tack endovascular system is preloaded with four self-expanding nitinol devices for BTK interventions or six devices for ATK interventions.
In addition to TOBA II BTK, Intact Vascular is sponsoring the TOBA II and TOBA III clinical trials to evaluate the Tack system. TOBA II is investigating the combination of the Tack implant with plain angioplasty balloons and the Lutonix drug-coated balloon (DCB; BD Interventional) in arteries above the knee. TOBA III is investigating the combination of the Tack implant with the In.Pact Admiral DCB (Medtronic), with a long lesion subset. All three trials have completed primary endpoint analysis.