TAVR replica
Make the precious, accessible
The Challenge:
How can a medical device marketing professional economically enable clinical conversations around a transcatheter valve replacement when the actual device, at more than $32,000 is prohibitively expensive and delicate?
By calling Pulse MDM to design and make a realistic looking replica device that is 99.9% lower in cost.
Transcatheter aortic valve replacement (TAVR) is a minimally invasive heart procedure to replace a narrowed aortic valve that fails to open properly due to aortic valve stenosis. The replacement valve is delivered via one of several access methods including transfemoral (in the upper leg), transapical (through the wall of the heart), and subclavian (beneath the collar bone).
The implantable valve is costly because it is made in an ISO-13485 manufacturing facility, under clean room conditions and strict material traceability protocols. Further it uses valuable and delicate porcine leaflets that require sophisticated production techniques with expensive, implantable grade materials. Putting actual devices in the field for marketing reps to use is cost prohibitive. Our client needed an inexpensive and durable model to show the replacement valve to physicians so they can show anddiscuss hemodynamics, low delivery profiles, advanced sealing and controlled deployment with their patients.
Model Design:
There were three critical components to the Medtronic TAVR valve: the nitinol cage, the porcine leaflets and the external wrap. After extensive materials research and design development, For the optimal cost, Pulse MDM determined the cage and leaflets were best replicated using injection molding and the outer wrap could be simulated with a dipping method process. The cage could be molded with a flexible, yet durable material to conform the to the aorta model and the leaflets in a soft material to replicate the pliability of real porcine tissue. We planned to replicate the wrap by dipping the assembly in a coating.
Model Development:
Due to the complex geometry of the cage, high-precision tooling with 12 moving parts was required for the most accurate representation. The dipping of the outer wrap required extensive material exploration and experimentation. The coatings that adhered well to the cage resin were turned out to be too viscous resulting excessive thickness and obscuring the view of the cage underneath. A thinner coating was tested, and replicated the wrap perfectly, but then became brittle and crumbled off when it dried. Ultimately, patience and perseverance paid off and we achieved the desired outcome.
Model Solution:
Pulse MDM created a durable, visually accurate model of the Medtronic TAVR cage. Because Pulse was able to develop a solution that kept the cost below $25 per model, thousands weremade and shared with clinicians across the United States and with their affiliates worldwide.
Using this model Medtronic is facilitating thorough clinical discussions with physicians and patients, with sales representatives and healthcare administrators, using a replica depicting all the features of the production TAVR that was designed and engineered by Pulse MDM.
Although this custom model is not available for sale to the public, we would be delighted to make you a version that is unique to your medical device and procedure. Please use this link to start the process of receiving a model concept that is a visual representation of how clinicians and patients will experience your product and procedure. Pulse MDM does not charge for model concepts or the conversations around them so there is no risk to see how we can help you to tell your story in the most engaging and memorable way possible.
Procedure Overview:
Transcatheter aortic valve replacement (TAVR) is a minimally invasive heart procedure to replace a narrowed aortic valve that fails to open properly due to aortic valve stenosis. The replacement valve is delivered via one of several access methods including transfemoral (in the upper leg), transapical (through the wall of the heart), and subclavian (beneath the collar bone).
Transcatheter Aortic Valve Replacement