SIRIUS Endoscope System

Developed by Precision Robotics, the SIRIUS Robotic Flexible Endoscopic System provides surgeons with a 3D articulated camera that can change viewing direction during minimally invasive procedures. The system received FDA 510(k) clearance in December 2022, establishing its safety and efficacy for gynecological laparoscopic surgery applications.

Product Overview

SIRIUS addresses a persistent challenge in laparoscopic surgery: conventional rigid scopes require physical repositioning to view different anatomical areas, creating workflow interruptions and limiting visualization in confined spaces. The system’s three-degree-of-freedom articulated tip enables C-shaped and S-shaped bending, allowing real-time angle adjustment without scope removal.

The fully integrated design houses the video processor within the compact unit rather than requiring a separate cart-based system, reducing operating room footprint and setup complexity.

Key Features

SIRIUS’s three-degree-of-freedom articulated tip enables C- and S-shaped bending mid-procedure, giving gynecological surgeons real-time angle adjustment without removing and reinserting the scope.

• Articulated Tip: Three degrees of freedom enabling C and S-shaped bending patterns for thorough visualization without scope repositioning
• Stereo 3D Imaging: Dual-camera configuration provides depth perception with 1080p HD resolution
• Wide Field of View: 120-degree viewing angle with 10-100mm depth of field
• Compact Integration: Video processor built into the system, eliminating external processing cart
• Single-Use Tip: Disposable flexible tip component ensures sterility and consistent performance

Technical Specifications

Cleared by FDA in December 2022, SIRIUS delivers 1080p stereo 3D imaging through a 10mm articulated scope with a 120-degree field of view and 3-DOF bending for gynecological laparoscopy.

Clinical Applications

SIRIUS targets gynecological laparoscopic surgery as its primary indication, with particular advantages in:

Single-Incision Laparoscopic Surgery (SILS): The articulated camera compensates for the limited instrument triangulation inherent to single-port access, providing visualization angles impossible with rigid scopes.

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES): The flexible tip navigates the curved access path of transvaginal approaches more effectively than conventional equipment.

Standard Multi-Port Laparoscopy: Even in traditional multi-port procedures, the articulated viewing capability reduces the need for scope repositioning during complex dissection.

Clinical Evidence

First-in-human trials conducted at Gleneagles Hospital Hong Kong followed the IDEAL framework (Idea, Development, Exploration, Assessment, Long-term follow-up). Published Stage 1 and 2a results documented:

• Successful completion of all planned procedures
• No device-related adverse events requiring conversion to conventional endoscopy
• Positive surgeon and camera operator feedback on visualization capabilities
• Iterative improvements implemented based on clinical observations

Ongoing multi-center trials (NCT05048407) are expanding the evidence base with additional surgeons and institutions.

Regulatory Status

The FDA clearance (K221642) established substantial equivalence to the Olympus LTF-190-10-3D Endoeye Flex 3D Deflectable Videoscope, confirming safety and effectiveness for the intended surgical applications.

Design Recognition

The SIRIUS system received the iF Design Award, with judges noting the combination of functional innovation and refined industrial design. Design elements include an angled display and curved handpiece that complement the system’s dynamic articulation capabilities.

The Geneva Exhibition of Inventions awarded SIRIUS a Gold Medal with Jury Congratulations, recognizing the technical innovation in surgical visualization.

Frequently Asked Questions

What surgeries can SIRIUS perform?

SIRIUS is indicated for gynecological laparoscopic surgery, including both standard multi-port procedures and advanced techniques like single-incision surgery (SILS) and vaginal natural orifice surgery (vNOTES). The articulated camera provides particular advantages in procedures requiring visualization of difficult-to-reach anatomical areas.

How does SIRIUS compare to conventional laparoscopes?

Unlike rigid laparoscopes that require physical repositioning to change viewing angles, SIRIUS features a three-degree-of-freedom articulated tip that can bend during surgery. This allows surgeons to view different areas without removing and reinserting the scope, potentially reducing procedure time and improving visualization in confined spaces.

Is SIRIUS FDA approved?

Yes, SIRIUS received FDA 510(k) clearance in December 2022 (K221642), establishing substantial equivalence to predicate devices and confirming safety and effectiveness for gynecological laparoscopic surgery.

What is the SIRIUS system’s imaging quality?

SIRIUS provides stereoscopic 3D imaging at 1080p HD resolution with a 120-degree field of view. The stereo camera configuration delivers depth perception to assist surgical precision.