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 implantable production device is very expensive and delicate? By calling Pulse MDM to make a replica device.  The production implantable valve is costly because it is made in an ISO-13485 manufacturing facility, under clean room conditions. Further it uses valuable and delicate porcine leaflets and employs sophisticated manufacturing techniques with expensive implantable grade materials.  Our client wanted to cost effective and durable way to show the replacement valve to physicians to discuss hemodynamics, low delivery profile, advanced sealing and controlled deployment.

 

Model Design:

There were 3 critical components to the Medtronic TAVR valve; the nitinol cage, the porcine leaflets and the external wrap.  After extensive research and design development, Pulse MDM determined the cage and leaflets were best replicated using injection molding and the outer wrap could be replicated with a dipping method.  The cage was molded in 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 to the cage resin were too viscous and created an outer wrap that was too thick, obscuring the view of the cage underneath.  When a thinner coating was tested, it replicated the wrap perfectly, but became brittle and crumbled off when it dried.   However, 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.  Thousands of parts were economically made and shared with clinicians across the United States and with their affiliates worldwide.

Today Medtronic is facilitating thorough clinical discussions with physicians and patients, with sales representatives and healthcare administrators, using the Pulse MDM made TAVR replica which depicts all the features of the production TAVR.

 

Evolut platform

 

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

 

Although this custom model is not available for sale to the public, we are 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.