“We are thrilled to have the TOBA III data published in the Journal of Vascular Surgery,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “This peer-reviewed article adds to the strong body of evidence supporting use of the Tack Endovascular System for focal dissection repair when treating lesions both above- and below-the-knee.”
Notably the first FDA-approved vascular implant for below-the-knee post-angioplasty dissection repair, Tack® implants are designed to optimize balloon angioplasty outcomes in the challenging critical limb ischemia (CLI) patient population.
Tack Endovascular System® Receives FDA Approval for Below-the-Knee Post-Angioplasty Dissection Repair
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.
Results of its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial, successfully achieving all primary (P < 0.0001) and secondary endpoints with very low rates of major amputation and all-cause death.
Intact Vascular, Inc. announced the first commercial use of its Tack Endovascular System in multiple sites across the United States. Recently FDA-approved for above-the-knee interventions, the first-of-its-kind dissection repair device is implanted post-angioplasty to resolve dissections in patients with peripheral arterial disease
Intact Vascular reported the U.S. Food and Drug Administration approval for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease.
“The Tack System provides a much-needed therapeutic option for treating dissections in the superficial femoral or popliteal arteries following balloon angioplasty,” said Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany. “I am very pleased with my experience using the implant, and I am excited to incorporate this technology into my above and below the knee treatment algorithms going forward.”
Intact Vascular to Sponsor Post-Angioplasty Dissection Symposium and Present an Update on the TOBA II Pivotal Study Results at the 2018 VEITHsymposium
Tack Endovascular System®, a first-of-its-kind dissection repair device, is designed to preserve vessel integrity and enhance blood flow following balloon angioplasty.
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