FlexDex Surgical has announced that over 100 clinical procedures have been successfully completed with its AXIUS™ 8mm Needle Driver (“AXIUS”) in the United States (US), since securing FDA registration in June 2023.
AXIUS is FlexDex’s second-generation wristed laparoscopic needle driver, designed for complex reconstructive suturing. The proprietary mechanical design allows the user to make precise articulated and rotational movements of the needle controlled by just their fingertips, while maintaining tactile feedback of the tissue. AXIUS can be reprocessed 10 times, maintaining a low cost per procedure.
As part of the initial clinical experience, FlexDex conducted a pilot launch with a group of US surgeons to gather data on the product’s value and usability. The AXIUS Needle Driver was used across a wide range of applications, including hernia repair, bariatric and colorectal procedures, and gynecology.
A key outcome of the pilot launch was the ease of adoption for laparoscopic surgeons. This was shown by the minimal training time (under 3 hours) required to achieve pre-clinical competency, the high level of complex suturing task completion from first clinical experience, and the ease of integration into the laparoscopic workflow.
This early clinical experience demonstrated considerable advantages over laparoscopic alternatives. AXIUS successfully enabled suturing in complex angles that are very challenging with laparoscopic instruments, such as on the anterior abdominal wall in ventral hernia repair. In addition, surgeons stated significant ergonomic benefits with AXIUS compared to laparoscopic needle drivers.
During a non-clinical comparison, the surgeons also achieved a higher quality of suturing with AXIUS than with laparoscopic needle drivers, including greater needle driving precision, increased efficiency and reduced tissue deflection.
“It has been amazing to see the ease of introduction of our AXIUS technology throughout the pilot launch and the great advantages experienced by surgeons,” said Dr. James Geiger, Co-Founder and CEO of FlexDex. “The additional precision and anatomical access afforded by AXIUS can enable a greater number of complex procedures to be performed by MIS, and provides a high dexterity laparoscopic option to complement existing robotic programs.”
A wider commercialization of the AXIUS Needle Driver is planned for this year.
Source: FlexDex Surgical