xDot Medical has received FDA investigational device exemption (IDE) approval to begin a pivotal clinical trial of its Access Management System (AMS) for closing large-bore femoral arterial and venous access sites following catheter-based procedures.
The study will enroll 266 patients, including roll-in subjects, with follow-up through 30 days after treatment. The trial will evaluate the safety and effectiveness of the AMS, with Dr. Rahul P. Sharma (Stanford Healthcare) and Dr. Devi G. Nair (St. Bernards Medical Center) serving as national principal investigators.
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The investigational device is designed to address challenges associated with large-bore vascular closure, incorporating features such as maintained guidewire access and automated coaxial suture cinching to improve procedural efficiency and hemostasis.
Founder and CEO Aashiish Agnihotri said:
“The FDA approval of our pivotal IDE is a significant milestone for xDot Medical. We appreciate the contributions of our team and collaborators and look forward to evaluating the xDot AMS with leading clinical investigators in this pivotal study.”
The IDE approval marks an important step toward generating clinical evidence for xDot Medical’s vascular closure technology as large-bore catheter-based interventions continue to expand.
