Great news about 3D printed surgical guides: A new advanced surgical planning tool received FDA clearance for use in VA facilities, quickening pre-surgery process.
Reconstruction of the jaw often uses bone grafts obtained from other locations of the body to fill the void left after the tumor is removed. While effective, this technique requires significant planning time, surgical precision, and adjustments during surgery to ensure proper fit and function.
Advances in design and planning software, as well as 3D-printed surgical guides, have allowed for a more advanced approach.
With access to new tools, surgeons can plan more of the approach prior to surgery and produce surgical guides to precisely execute that plan in the OR. This results in a more patient-centric approach, savings in operating time and costs, and better patient outcomes.
Advanced surgical planning tool
Currently, VA physicians must obtain surgical planning services and 3D-printed surgical guides from outside vendors. Because this process can take several weeks, it’s frequently not pursued as Veterans may require rapid treatment.
System lets surgical teams personalize approach prior to surgery
Recent developments from VA Ventures and the VHA Office of Advanced Manufacturing (OAM) have allowed VA to bring this service in-house.
The Oromaxillofacial Advanced Surgical Planning (OMF ASP) System utilizes medical imaging, such as CT scans, to create surgical plans to guide the procedure. The system can then produce digital and physical patient specific designs, including surgical plans, guides, models and templates. These can then be used for planning and performing surgeries.
The OMF ASP System recently received clearance from the Food and Drug Administration (FDA). This allows for the system planning services, anatomic models, templates and surgical guides to be available to VA surgeons in-house.
The OMF ASP System is the first clearance of a Class II medical device for VHA as both the developer and manufacturer. 43% of medical devices fall under this category and include a range of device types such as powered wheelchairs and some pregnancy test kits. This is the first instance of any hospital system receiving FDA clearance on a 3D Printed Class II medical device.
System safer for the Veteran
The system provides an opportunity for surgical teams to personalize and optimize the approach prior to surgery. This reduces the amount of time spent adjusting during surgery, resulting in faster operations and less time under anesthesia, which is safer for the patient.
Since the system is produced in-house, this provides access to faster surgical treatment for Veterans, critical for some tumors, improving post-surgery results.
The OMF ASP System provides more tools to create the best surgical approach specific to each patient. It also provides a level of detail aligned with the intricacies of the face, resulting in improved surgical accuracy.
Cost savings significant
Cost savings is also a significant benefit. While Advanced Surgical Planning services and surgical guide products often cost $5,000 or more, there is a potential for a savings of $2,000 – $3,000 per service.
The OMF ASP System will have a limited hospital release in fall of 2022 and will be scaling up to national general availability within VHA in 2023.
This is the third medical device product that OAM has developed and is producing in-house for VHA patients and clinicians. In March 2021, the GioStent was produced in-house for a Veteran in need and in January 2022 the Thermal Fuse Cover was released and produced for use.