VisionAir 3D Stents are patient-specific silicone Y-stents designed by treating physicians for their individual patients in the cloud-based VisionAir 3D Stent Architect Software Application. This allows physicians to tailor the 3D Stent to each patient’s unique anatomy to reduce complications caused by poorly-fitting stock silicone stents, resulting in longer implantation times and less frequent stent revision procedures.
VisionAir 3D Stents have broad indications for the treatment of symptomatic central airway obstruction (CAO) in mature individuals that are 22 years of age or older. 3D Stents may be implanted in any location in the airway that a physician can reach with their rigid bronchoscope for implantation. This means that the 3D Stent is unique in that it can be designed to fit carinas distal to the main carina, while current traditional silicone Y-stents have stock diameters, angles, and lengths specifically designed for only the main carina.
VisionAir 3D Stents are cleared by the FDA for use in the US for treatment of symptomatic central airway obstruction (CAO) in mature individuals that are 22 years of age or older.
VisionAir 3D Stents are available in the US at a number of medical centers around the country. Please take a look at our About page for a list of centers where 3D Stents are being used by leading pulmonologists.
VisionAir 3D Stents are manufactured, shipped, and delivered in 4-6 business days from the day that a PO is received from your medical center.
VisionAir believes that patient-specific stent design should be in the hands of the individuals who know the patient, their history, and clinical goals best: their Physicians. Everything starts with you uploading a CT scan to the cloud-based VisionAir 3D Stent Architect Software Application (V3D App). The VisonAir engineering team segments a 3D model of the airway from the CT scan within 24hrs, enabling 3D Stent design to begin. All in your web browser, the V3D App enables you to design a 3D Stent to your desired specifications while using the segmented model of the airway as a template to determine optimal diameters, branch angles, and lengths. Finally, you Approve the Stent Design as a “3D prescription” for your patient and an order request can be placed in the V3D App to “fill” this prescription. Once a PO is received from the physician’s medical center, the VisionAir manufacturing team will begin producing the 3D Stent using 3D-printing and silicone injection to be shipped in 3-5 business days from the day that the PO is received.
All you need to design a 3D Stent is an account in the VisionAir 3D Stent Architect Software Application (V3D App) and completion of virtual training with a VisionAir engineer. The only requirement to access and use the V3D App is the Google Chrome Web Browser and a computer with a mouse. No installation of software is necessary.
VisionAir 3D Stent Architect does not anonymize the patient data. While anonymized scans are acceptable, the patient data is important to make sure the stent makes it to the correct patient at the hospital. We put the MRN of the patient on the device label to help with this. If an anonymized scan is uploaded, it is up to the physician and medical center to ensure that the stent makes it to the correct patient. All patient data is encrypted and stored on VisionAir’s secure AWS servers.
According to our FDA-cleared indications for use, VisionAir 3D Stents can be implanted for up to 12 months.
VisionAir 3D Stents should be used within 3 months from the date of manufacture. An expiration date will be printed on each device label. Since 3D Stents are patient-specific and shipped nonsterile, the expiration date is based on the potential for the airway anatomy to change over time rather than sterility. According to the Instructions for Use (IFU), 3D Stents should be sterilized immediately prior to use. The IFU is shipped with each 3D Stent and can also be downloaded on the Support Page in the VisionAir 3D Stent Architect Application.
Typically Y stents which are tracheal/bronchial are billed using a cluster of CPT codes and the multiple endoscopy rule: CPT 31631, CPT 31636, CPT 31637, CPT 31638.
VisionAir 3D Stents are deployed using standard rigid bronchoscopy tools similar to stock silicone airway stents. No special equipment is necessary.
Based on our testing, our stents are significantly lower radial strength than other stock silicone stents currently on the market. Since 3D Stents fit the airway better than stock stents, we designed them to be lower radial strength. With an improved fit, 3D Stents have more surface area contact with the airway wall. This leads to better distribution of forces and less pressure points that that may cause kinking. For example, a straight stock stent implanted in the LMS may lead to kinking, since it does not follow the curvature of the airway.
Go to our Contact Us page on this site and submit the form to us. A VisionAir team member will reach out shortly with next steps such as V3D App account registration, virtual training, and getting VisionAir setup as an approved vendor at your medical center. You may also get in contact with us by emailing email@example.com.
Software training is completed virtually in a one-on-one session with a VisionAir Solutions engineer where they are guided through the VisionAir 3D Stent Architect Software to learn the key features and functionality. Training sessions typically takes less than an hour.
Yes, but we strongly prefer to train physicians individually. We highly recommend individual sessions to ensure that every user has ample time to interact with the software and ask as many questions as possible.
If you have been experiencing difficulty breathing and your physician has attributed your symptoms to central airway obstruction (CAO), then you may benefit from a 3D Stent.
The VisionAir 3D Stent is being used around the country by pulmonologists at leading medical centers. Check out our About page for more information and to see if there is a medical center by you using our stents. You may also reach out to us on our Contact Us page or send us an email at firstname.lastname@example.org.
Reach out to us on our Contact Us page or send us an email at email@example.com so that we can discuss your options. The VisionAir Solutions team is happy to reach out to your local medical center to discuss the utilization of 3D Stents in their pulmonology practice.