November 30, 2022 06:00 AM Eastern Standard Time
IRVINE, Calif.–(BUSINESS WIRE)–Today Viseon Inc. announced preliminary results from the clinical use of the MaxView® intraoperative imaging technology compared to traditional imaging modalities during minimally invasive lateral lumbar interbody fusion surgery (transpsoas and ante-psoas approaches). The MaxView System is a state-of-the-art, tower-less digital platform for minimally invasive access and high-definition visualization. This system enables a highly magnified unobstructed view of the surgical corridor and critical anatomy to be projected in real time onto HD flat panel displays for the surgeon and entire OR staff, including trainees to observe, learn and engage. The Viseon MaxView System is a disposable HD camera that enables the digital capture of critical soft tissue content for further analysis, teaching and merging into predictive procedural planning algorithms toward optimized patient outcomes.
The Viseon Clinical Advisory Board utilized a validated Task Load Index (TLX) to evaluate the spine surgeon and OR teams experience with and without the use of The Viseon MaxView System. The TLX measures the degree of procedural demand-burden on the surgeon and OR Team from multiple categories including:
|1) Mental Demand||6) Frustration|
|2) Physical Demand||7) Safety Demand|
|3) Temporal Demand||8) Ergonomic Demand|
|4) Performance||9) OR Staff Demand|
|5) Effort Demand||10) Procedure Complexity|
Preliminary results from ninety-eight (n=98) clinical procedures have been so far included in the Viseon MaxView System TLX database between June 2021 and October 2022, with major contributions from eight (8) spine surgery institutions, including:
|1) Hospital for Special Surgery, New York, NY||5) Scripps Green Hospital, San Diego, CA|
|2) Virginia Mason Medical Center, Seattle, WA||6) Valley Hospital, Hackensack, NJ|
|3) Barrow Neurologic Institute, Phoenix, AZ||7) Rush University Medical Center, Chicago, IL|
|4) HCA Florida S. Tampa Hospital, Tampa, FL||8) IRCCS Istituto Ortopedico Galeazzi, Milan, Italy|
Analysis of the Viseon MaxView System TLX database (Table 1) yielded statistically significant benefits in every measure of demand with the use of The MaxView System for lateral access spine fusion procedures of similar deformity, diagnosis and surgical complexity.
|Table 1 (n=98)|
|Without Viseon||With Viseon|
|Mean (SD)||Mean (SD)||p-value|
|Mental Demand||12.74 (3.84)||9.60 (4.92)||0.005*|
|Physical Demand||12.13 (4.35)||7.37 (4.90)||<0.001*|
|Temporal Demand||12.26 (4.06)||4.84 (3.58)||<0.001*|
|Performance||19.52 (1.69)||19.42 (2.07)||0.882|
|Effort Demand||13.96 (4.32)||9.43 (4.56)||<0.001*|
|Frustration||11.04 (5.54)||5.28 (4.17)||<0.001*|
|Safety Demand||13.65 (5.01)||9.09 (5.89)||0.002*|
|Ergonomic Demand||12.91 (4.94)||5.85 (4.23)||<0.001*|
|OR Staff Demand||10.33 (3.83)||6.45 (5.91)||<0.001*|
|Procedure Complexity||10.95 (3.98)||11.38 (5.66)||0.777|
The Company continues to add cases to the database to improve the generalizability of the results.
Commenting on these results, Sheeraz Qureshi, MD Co-Chief of Spine and an Associate Attending Orthopedic Surgeon at Hospital for Special Surgery, stated, “The Viseon TLX data is enlightening and a very important indication of how the MaxView technology contributes to improving patient care. My OR is very busy with advancing minimally invasive techniques that have imposed some additional burdens on me as a surgeon and on the entire OR staff. The Viseon TLX data supports that the MaxView technology addresses these burdens by improving the surgeon’s comfort, procedural experience and efficiency, as well as improving OR workflow and teaching safety, without compromising overall performance. I look forward to continuing to contribute to this important data set.”
Further commenting, Jeffrey Valko, Viseon Chief Executive Officer, stated, “Fundamentally, our ability to uniquely enable highly magnified, high-definition intraoperative visualization that relieves the surgeon of multiple procedural demands while also engaging the entire OR Team, leads to procedural efficiencies and increased patient safety, particularly in a young surgeon training environment. Participating surgeons also scored the use of Viseon MaxView as highly valuable for less fluoro use, attributed to Viseon enabling direct real time visualization, thereby reducing reliance on x-ray images with the associated OR Team and patient radiation exposure. In mid-2023, the Viseon technology platform will be expanded to include a 4K image controller for advanced state-of-the-art image quality and added depth perception without a major capital equipment purchase.”
About Viseon, Inc.
Viseon, Inc. is privately held and was founded to bring the first and only state-of-the-art single-use disposable HD imaging technology to the field of minimally invasive surgery (MIS). Viseon’s goal is to advance minimally invasive surgery with innovative technology that enhances intraoperative visualization in an otherwise compromised setting. In doing so the Company will disrupt antiquated modalities for visualization, enable the digital future and accelerate adoption of advanced surgical techniques, improving the surgeon experience, patient outcomes and safety.
Zazie Peltier, Director of Marketing