Cardiovascular Systems, Inc., based in St. Paul, Minnesota, is a medical device company focused on developing and commercializing innovative solutions for treating peripheral and coronary artery disease (PAD and CAD). The company’s Orbital Atherectomy Systems treat calcified plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. To help fight the battle against CAD and PAD, CSI works continuously to advance their devices and develop new innovations. CSI’s innovative drive has expanded their utilization of 3D printing across all facets of their business, greatly benefiting patients through successful treatment of atherosclerosis.
The Research and Development team uses 3D printing to not only make prototype devices, but also to simulate clinical environments in which to test them. “With 3D printing, we can be very quick in our process by developing a prototype component one week and then gather feedback from physicians the next week,” said Will Besser, a senior product development engineer. “The earlier in the development process you find and fix issues, the less expensive it is. That’s where rapid prototyping really shines, it helps get actual physical objects in your hand, saving us time and money.” CSI evaluates some performance using 3D printed models based on patient imaging data. Using 3D recreations of actual anatomy allows for faster, more clinically relevant feedback.
“We take angiographic images and use 3D modeling to recreate the complex anatomy of different coronary vessels, 3D print a realistic model and stress test different situations to see where we can improve our device,” said Nick Ellering, a product development engineering manager.
CSI’s Reliability Engineering team also benefits from in-house 3D printing during failure analysis process on complaint devices, in addition to standard failure analysis procedures. “We’re able to quickly model clinically relevant anatomical pathways to recreate field failures on the bench in an effort to understand the mechanism by which they occurred,” said Henisha Dhandhusaria, a reliability engineer. “We experiment with different vessel path models and print materials while making iterative design modifications to the models during failure analysis investigations. This helps find the root cause of failure more efficiently and in a controlled manner.”
Printing with Stratasys PolyJet technology allows the models to incorporate both soft tissue vessels and hard calcification analogues within the same model to replicate atherosclerosis. Once the device has been deployed in a 3D printed model, CSI splits the model in two so engineers can measure how effectively the device removed calcifications from different types of vessels. “It’s a great way to get instantaneous feedback,” said Jake Draxler, a product development engineer. “We’ve also experimented with multi-colored, multi-layered materials. As our device removes simulated lesion material, we can easily see and measure how far into the multicolored layers it’s orbiting.”
Learn more about how CSI incorporates 3D printing into every facet of their products’ lifecycle including sales and marketing.