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July 16th, 2015

Experimental Device — and a Fast-Track Approval From the FDA — Give Patient Real Results

By In the Loop

A 3-D printer provides real results for Jack Snyder Had this been a different time and place, Jack Snyder would have been down to two options after doctors discovered an aneurysm on his aorta: Do nothing and hope the ballooning vessel didn’t pop, or have open heart surgery to try and fix it. While the second option might seem like the obvious choice, Mayo Clinic vascular and endovascular surgeon, Gustavo Oderich, M.D., tells Minneapolis-St. Paul’s Fox9 News that, given Snyder’s medical condition, surgery could actually have posed a higher risk than option number one. His aneurysm was “very large” and had “a significant risk of rupture,” Dr. Oderich says, adding that “it’s fair to say that his risk of death would be significantly higher with open surgery.”

Fortunately, things continue to change rapidly, and dramatically, in the medical world -- especially at Mayo Clinic, where Dr. Oderich and his colleagues came up with a third option, thanks to a U.S. Food and Drug Administration program that’s helping to “fast track” new medical technologies for patients like Snyder.

As Fox9 reports, Dr. Oderich and his colleagues developed a “less invasive procedure” for Snyder that involved inserting a “test device” into his heart. If all went well, the device would keep his artery from rupturing. But before the team tried the procedure, they wanted to be sure they knew exactly what they were doing. So as the station reports, they used a 3-D printer to make a replica of Snyder’s damaged aorta, which they then hooked up to a pump to “simulate Snyder’s heartbeat and blood pressure.” Then, they practiced “inserting an experimental stent” inside the fake aneurysm.

When it came time for Dr. Oderich and his team to perform the actual procedure on Snyder, it was a case of practice makes perfect. After first cutting a small opening in his arm, they “threaded the stent through a blood vessel” into Snyder’s “bulging aorta” to re-route the blood flow. “So now the blood is flowing inside the stent and no longer in the aneurysm,” Dr. Oderich says.

Fox9 reports that Mayo is currently “one of five sites in the United States taking part in this fast track approach” and that it was allowed to do so by the FDA after exhausting all other treatment options for Snyder. It’s hoped that what’s learned from the results of the procedure “could eventually speed up its approval for widespread use.”

Snyder doesn’t need to wait for results to come in; he’s already convinced of the device’s effectiveness. He was well enough to leave Mayo and go back home “after just a few days,” and tells Fox9, “I couldn’t believe that I was out this quick.”

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Tags: Dr Gustavo Oderich, Innovation, Patient Stories, Vascular Surgery

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