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FlexDex Surgical Secures FDA Registration for AXIUS™ Needle Driver


FlexDex Surgical (“FlexDex”), a Michigan-based developer of innovative devices for minimally invasive surgery (MIS), has announced that its AXIUS™ 8mm Needle Driver (“AXIUS”) has been registered with the U.S. Food and Drug Administration (FDA).

The articulating AXIUS Needle Driver is the next generation technology from FlexDex and is the first of a full suite of AXIUS Advanced Laparoscopy devices in the pipeline at FlexDex. With new streamlined architecture, AXIUS has been designed based on the experiences and successes of the first generation FlexDex articulating needle driver, a single use device launched in 2017.

The AXIUS Needle Driver is a mechanical hand-held articulating laparoscopic device designed for complex and precise suturing. Unlike traditional laparoscopic needle drivers, AXIUS allows the surgeon to make small articulation and rotational adjustments with just their fingertips. This enables precise needle positioning and delicate movements required for complex reconstructive suturing, while the mechanical design maintains tactile feedback of the tissue.

AXIUS can be reprocessed multiple times, reducing the cost per procedure. It has a minimal learning curve and is easily integrated within standard laparoscopic workflow, allowing the surgeon to remain at the operating room table and in direct contact with the patient.

“The talented FlexDex team has worked tirelessly over the last two years to develop the unique AXIUS architecture. We believe our technology has the potential to dramatically elevate and grow laparoscopy. Surgeons have performed highly complex procedures with our first generation device and AXIUS has the potential to achieve much more,” said Dr. James Geiger, Co-Founder and CEO of FlexDex. “With AXIUS, surgeons can access a similar level of dexterity in both their robotic and non-robotic surgical procedures, enabling more procedures to be performed via MIS. This is a huge step toward our goal of bringing the benefits of MIS to more patients around the world.”

The AXIUS Needle Driver will initially be launched with a small group of identified users in the United States. A wider commercialization of the device is planned for next year. Additional AXIUS Advanced Laparoscopy devices are in development, which are designed to simplify the most complex tasks in minimally invasive surgery, such as precise dissection. FDA 510(k) clearance for the full AXIUS suite is expected in 2025.

Source: FlexDex Surgical

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