Vascular Disease Model

The Challenge:

Cook Vascular was planning to introduce their Venous Therapy Story in the US for the first time. Their products were available outside of the US for many years but Cook had not developed a formal product education program in the U.S. They came to Pulse MDM to help fully educated their reps on the targeted vascular diseases and their treatment programs. Historically, Cook utilized water baths made by their in-house engineering team to conduct training but they we ready for a more convenient, professional and clinically relevant hands-on training solution.

Cook Medical targeted several audiences: sales reps, cardiologists, vascular surgeons, interventional radiologist, fellows, residents, radiologic and scrub techs, nurses, and manufacturing employees.  Senior leadership wanted to tell the story of their peripheral venous therapies as a disease progression cycle which they base their professional education program on.

Venous diseases are complex, progressive, and unpredictable.  The model Cook commissioned was intended to promote conversations that venous diseases are progressive and if left untreated,  become increasingly more debilitating and seriously decrease quality of life.  The goal of Cook venous therapies are to  “break the cycle,” stop venous diseases from progressing and improve quality of lives.

Cook has a broad product line, and narrowing down the products and features to promote with a custom model required careful consideration.  Ultimately, Cook selected its Zilver Vena Self-Expanding Venous Stent to demonstrate Iliofemoral venous outflow recanalization through stenting and the TriForce Peripheral Crossing to directly treat vascular obstructions.

The models needed to be flexible however to accommodate accessory products such as Celect IVC filter, vessel access (micropuncture introducers) angiographic catheters and crossing wires.


Model Design:

To create a clinically relevant Zilver Vena demonstration, the Pulse MDM model would address  a so-called May-Thurner Obstruction, also called Non-Thrombotic Iliac Vein Lesion (NIVL).  This syndrome is when a nearby artery compresses the left iliac vein, reducing blood flow back to the heart.

For the TriForce we tested multiple approaches  to replicating the resistance typically felt when passing a peripheral crossing set through a vascular fibrous obstruction.  Pulse conducted our own testing with Cook supplied devices and sent the most promising results to Cook for comment and final approval.

To demonstrate proper placement and provide visualization of the Celect IVC filter, the model to includes a clear inferior vena cava (IVC).

Vascular access for these three products is achieved through the internal jugular, femoral and popliteal so the model was required to include vasculature from the neck to the knees.

The procedures are completed with the use of flouroscopy but to keep the demonstration convenient and portable, Pulse MDM planned for the model to be clear to eliminate the need for costly and cumbersome visualization technologies.


Model Solution:

The May-Thurner obstruction was created by replicating the iliac vein’s soft lumen expansion and conformability in highly dynamic anatomy, overlapped by a small portion of the iliac artery.  A thumb screw on the artery was assembled into a slotted hole in a clear support so the degree of impingement can be easily and subtly shifted to create different clinical scenarios.  The vessel was planned to be clear to see the Zilver Vena stent in situ.  Using the Pulse MDM model, clinicians can practice the steps leading up to stent deployment and observe how the stent restores the lumen to fully round and reestablishes blood flow to the heart.  The model enables quick and easy removal of the stent for rapid repeat training exercises.

Using the Pulse MDM model, Cook sales reps can now show how the Zilver Vena nitinol self-expanding stent provides durable symptom relief.  No longer are patients required to choose between conformability or sufficient lumen expansion.   The Zilver Vena model allows the sales rep to show how the open cell design provides flexibility and minimal foreshortening which can lead to fewer stents being used during the procedure.   The stretchy vessel provides an opportunity to show how the nitinol self-expanding material provides sufficient lumen expansion without unnecessary force.  Clinically relevant inferior and superior access sites allow the clinicians to experience the low profile, pin and pull delivery system that enables precise and smooth delivery.

The obstructed femoral vessel allows Cook to show the technique of telescoping and maneuverability of the TriForce crossing set through a chronic venous obstruction.   Real obstructed vessels have many fibers that crisscross within the vessel which would be expensive to manufacture and would require replacement with each use.   Pulse MDM’s obstructed femoral vessel was specially designed to replicate resistance but not require an expensive and logistically complicated consumable part.  The model provides a platform to show the inherent columnar strength of the Flexor Sheath.  The result is minimal recoil for continuous advancement, effortless pushability and trackability, reinforcing Cook’s key value message, “Cross the Unthinkable”.

Due to the length of the model, from the interior jugular to the popliteal near the knee, the model is split in half for portability and easily connects back together for seamless vessel cannulation.

Overall, the Pulse MDM model is easy to use and includes accurate anatomy and pathophysiology to have a conversation around what to be aware of and how to deploy the Zilver Vena stent or cross a lesion with the TriForce crossing set.


Procedure Overview: 

Non-Thrombotic Iliac Vein Lesion (NIVL), May-Thurner syndrome or iliac vein compression syndrome is a rare vascular condition that affects the iliac vein in the pelvis. It occurs when a nearby right iliac artery compresses the left iliac vein. The iliac vein brings blood from the pelvis and legs back up to the heart. The compression prevents blood from flowing properly, leading to narrowing and scarring.

May-Thurner Syndrome

Zilver Vena

Thrombotic iliac Vein Lesion which is an obstruction of the vein with synechia. The vein is highly scarred and thickens to become more like an artery than a vein.