WAYNE, PA — Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, recently announced the one-year data from its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial will be presented during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial event by Co-Principal Investigator, Patrick Geraghty, M.D., Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri. The Late-Breaking Clinical Trials livestream will be held on Thursday, June 25th at 7:30 pm ET.
The recently FDA-approved Tack Endovascular System® (4F) was studied in the TOBA II BTK trial, notably the first U.S. IDE clinical study approved to investigate the safety and effectiveness of a permanent vascular implant for below-the-knee (BTK) post-angioplasty dissection repair. The single-arm prospective study enrolled 233 patients at 41 sites in the U.S., Europe and New Zealand, the majority of which suffered from critical limb ischemia (CLI). All patients enrolled underwent standard balloon angioplasty and consequently experienced at least one dissection that required repair.
“We are honored to be one of the trials selected for VIVA’s Late-Breaking Clinical Trial livestream,” commented Bruce Shook, President and CEO of Intact Vascular. “The one-year TOBA II BTK data provide important evidence supporting the Tack implant’s sustained durability and will reinforce its importance as the only FDA-approved implant that, in combination with balloon angioplasty, preserves limbs in this challenging patient population.”
To register for the upcoming VIVA Late-Breaking Clinical Trials livestream, please visit vivaphysicians.org.
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