WAYNE, PA — Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, this week announced it 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, North Carolina 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% acute dissection resolution and 73.8% of wounds healed or improved at six months. Results demonstrated 95.7% K-M amputation-free survival, 87.3% K-M target lesion patency with significant improvement in toe-brachial index (TBI) and 92.0% 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, Missouri, 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.”
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