Boston Scientific FB-101-01 Fixate Suturing Device

Boston Scientific FB-101-01 Fixate Suturing Device 

• Model: FB-101-01 Boston Scientific
• Reference Number: M365FB101010

INCLUDES:

• (1) Fixate Suturing Device
• (1) Tension Guide

This medical supply or implant item is securely packaged within its original manufacturer's packaging, which remains undamaged. The inner and outer packaging is intact, ensuring the product's integrity and suitability for medical use.

The Boston Scientific FB‑101‑01, known commercially as the Fixate™ Suturing Device, is a disposable, semi-automatic tool created to anchor spinal cord stimulator leads or pain pump catheters directly to soft tissue. Designed for use during neuromodulation procedures, the device places a suture band quickly and securely around the lead or catheter anchor, fixing it to the fascia or inter-spinous/supraspinous ligament with minimal invasion. This design streamlines surgical workflow, reducing anchoring steps to under one minute in bench testing.

Boston Scientific acquired the Fixate™ technology from Anulex Technologies in April 2013 and immediately incorporated it into their neuromodulation product suite to help reduce lead migration—a common complication that can necessitate revision surgery. The semi-automated mechanism allows surgeons to deploy a secure suture with consistent tension using a small anchoring incision. Endorsements from physicians—such as Dr. Richard Bowman—highlight its efficiency and reliability for procedural lead fixation.

From a regulatory and labeling standpoint, the FB‑101‑01 model is commercially distributed, single-use, and does not contain natural rubber latex. It's intended exclusively as an accessory for securing spinal cord stimulation or pain-pump leads—not for direct implantation—requiring sterile technique and familiarization per the included Instructions for Use With its emphasis on speed, safety, and simplicity, the Fixate™ device helps reduce intraoperative time and the risk of lead migration, improving overall patient outcomes in neuromodulation surgery.