FDA Approves TOBA II BTK Pivotal IDE Clinical Study

Clears the Way for Commencement of the First, Large-Scale, International Clinical Study Examining Use of the Tack Endovascular System® to Repair Dissections Following Angioplasty in Arteries Below the Knee

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that the U.S. Food and Drug Administration (FDA) granted staged approval for the Company’s Investigational Device Exemption (IDE) application to begin its Tack Optimized Balloon Angioplasty II BTK (“TOBA II BTK”) clinical study. The study will examine the safety and efficacy of the Tack Endovascular System when used to repair dissections (or tears) in the arteries below the knee (BTK) following percutaneous transluminal angioplasty (PTA) as a treatment for critical limb ischemia (CLI).

Patrick J. Geraghty, M.D., Professor of Surgery and Radiology at the Washington University School of Medicine of St. Louis, and George Adams, M.D., M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC REX Hospital, Raleigh, N.C., are national Principal Investigators for the study. Doctors Geraghty and Adams bring a wealth of experience with the endovascular treatment of peripheral artery disease and with the design and conduct of clinical trials for endovascular therapies.

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