FDA Approves Below-the-Knee Post-Angioplasty Dissection Repair System

Intact Vascular Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, has received U.S. 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 Optimized Balloon Angioplasty II BTK (TOBA II BTK) clinical trial, notably the first study to enroll patients with advanced disease below-the-knee and 100% dissected vessels. The TOBA II BTK study enrolled patients suffering from critical limb ischemia (CLI), a condition associated with high rates of amputation and mortality.¹ Data from the trial was presented in a late-breaking scientific session at the 2019 VIVA conference.
 
“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 George Adams, M.D., M.H.S., director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital, Raleigh, N.C., and 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, multicenter, single-arm TOBA II BTK study met all primary endpoints with 100 percent acute dissection resolution and 73.8 percent of wounds healed or improved at six months. Results demonstrated 95.7 percent K-M amputation-free survival, 87.3 percent K-M target lesion patency with significant improvement in toe-brachial index (TBI) and 92 percent K-M freedom from clinically driven reintervention.
 
Additional co-principal investigators for the trial included Patrick Geraghty, M.D., professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Mo., and Andrej Schmidt, M.D., Division of Interventional Angiology, University Hospital Leipzig, Germany.
 
“The TOBA II BTK trial was very well-designed and the first to investigate a permanent vascular implant for treatment of post-angioplasty dissections in small vessels,” stated Dr. Geraghty. “FDA approval of the Tack (4F) implant marks a significant advancement in treatment of CLI, and I am pleased to have this pioneering technology available going forward.”
 
“We are thrilled to have the first peripheral vascular implant approved in the U.S for below-the-knee interventions,” remarked Bruce Shook, Intact Vascular’s President and CEO. “We will be working closely with our customers to implement a careful introduction of the Tack (4F) implant to those centers with the most pronounced need during this unprecedented time of stress on our healthcare system.”
 
The Tack Endovascular System is designed to repair dissections following peripheral balloon angioplasty. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) interventions, or four for below-the-knee (BTK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70 percent less metal than stents.² Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for peripheral arterial disease patients. 
 
Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. TOBA II is investigating the combination of the Tack implant with plain angioplasty balloons and the BD Interventional Lutonix drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK has also completed its primary endpoint analysis and is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee. TOBA III has completed its primary endpoint analysis and is investigating the combination of the Tack implant with the Medtronic IN.PACT Admiral (DCB), with a long lesion subset. 

References 
¹ Mustapha JA, Katzen BT, Neville RF, et al. Disease burden and clinical outcomes following initial diagnosis of critical limb ischemia in the Medicare population. J Am Coll Cardiol: Cardiovasc Interv 2018;11:1011-1012.
² Bosiers M, Scheinert D, Hendricks JMH et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016;64:109-16.
 
Tack Endovascular System and Tack are registered trademarks of Intact Vascular Inc.
The Tack Endovascular System is CE Mark Authorized under EC Directive 93/42/EEC.
 
The Tack Endovascular System (4F, 1.5-4.5mm) is intended for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).