Intact Vascular Announces Enrollment Completion of TOBA II BTK Clinical Trial

First-of-its-kind study designed to demonstrate safety and efficacy of the Tack Endovascular System® in treating post-PTA dissections below the knee

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced its Tack Optimized Balloon Angioplasty II BTK (TOBA II BTK) clinical trial successfully completed enrollment, ahead of schedule. This study further augments Intact Vascular’s robust clinical program and is notably the first pivotal trial investigating a permanent vascular implant in arteries below the knee.

“Patients with critical limb ischemia (CLI) experience painful symptoms and are at increased risk of amputation. Unfortunately, therapeutic options are very limited, and no scaffolding solutions are currently FDA-approved for BTK interventions,” commented George Adams, M.D., M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital, Raleigh, North Carolina, Co-Principal Investigator for the TOBA II BTK study. “The potential to have a treatment option that maintains vessel integrity and improves blood flow will have a significant clinical impact for treating patients with below-the-knee disease.”

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