SS_2025-16_Letter.pdf

Mentice Sole Source

To Whom it May Concern, This letter is to confirm that the Mentice G7+ is a sole source product, manufactured, serviced/supported, sold and distributed exclusively by Mentice Inc. This product must be purchased directly by institutions from Mentice Inc. at the address listed below.

There are no agents or dealers authorized to represent this product.

There is no other like item(s) or product(s) available for purchase that would serve the same purpose. The reasons are as follows:

Real Clinical Devices – It has been shown that training is most effective when the learner can perform the case safely with the same devices used in vivo and in the same order. Mentice strives to use the physical real device ”off the shelf” for performing each case. Other simulator companies only allow designated tools i.e.: A physical 5 fr diagnostic catheter becomes a balloon on the screen

Full Anatomy – It is accepted that the amount a trainee can learn in simulation is directly related to the degree of similarity between the simulated environment and the real-world task. Mentice incorporates the proper access, be it femoral or radial. This allows the learner to experience real clinical practice from the beginning of the procedure. Other simulator companies start well beyond access. Ie: A carotid procedure might begin in the arch.

Outcomes – Mentice builds their cases allowing the outcome to be determined by the trainees’ performance. There are no pre-determined pathways. Other simulator companies use predetermined pathways which means the case always has the same outcome regardless of the trainee performance.

Hardware – Mentice has full control of its hardware design and manufacturing. This allows for quick identification for needed market changes and upgrades when available.

Technology changes at a rapid pace and Mentice can react accordingly. Other companies may not have full control of their design/manufacturing chain. Mentice owns a proprietary haptic technology that allows users to experience the most realistic scenarios.

Calibration – In a scenario where the users are changing between software applications, Mentice does not require calibration. i.e.: if running EVAR using 24 fr devices and then you want to shift to running Neuro using micro catheters it is not necessary to calibrate the system to make this change. Other companies require calibration when there is a variance in sizing. This can take as much as 45 minutes.

Radial Access – To date Mentice is the only simulation company offering the Transradial approach in all 36 cases. The learner can choose groin or transradial approach at the beginning of the case.

Case –it – Allows for real patient anatomy to be easily downloaded to the simulator for practice. Mentice uses an FDA approved software to convert STL data files into the VIST software. There is no need to re-do vessel segmentation. Mentice does not charge added fees for this technology. Other companies require vessel segmentation to be performed on their software in order to download and in some cases charge annual fees to have the software.

Physics Based Software – Mentice uses physics-based software. This allows for superior tool interaction. This adds to the realism of performing the case and having the learner acquires a deeper understanding of proper device selection. i.e.: wires interact appropriately when catheters are being manipulated, and catheter tip shapes respond appropriately to the anatomy. Other simulator companies do not use this type of software which can compromise performance. Mentice also has the capabilities to trigger complications for complications management.

Bifurcation – Mentice is the only Endovascular Simulation company to offer bifurcation simulation capabilities. Bifurcation accounts for nearly 20% of PCIs and can be technically challenging. Adding bifurcation to our simulations adds another element of realism that will lead to improved patient outcomes and reduced cost.

Mentice Partnerships– Mentice is the only Endovascular Simulation company to offer an ICE Simulator with the Siemens AcuNav Volume Handle. Mentice is the only Endovascular company that has the capabilities to connect directly with Siemens & Phillips C-Arms directly into a catheter lab while turning radiation off.

If you desire additional information, don’t hesitate to contact me at 847-452-2167 or scott.lichtman@mentice.com.