Device experiment program saves lives, speeds products to market

Ron Hall owes his life to Mayo Clinic surgeon Gustavo Oderich and a Food and Drug Administration early feasibility study that helps get medical devices to market faster.

In December, the 80-year-old Blue Earth, Minn. man was preparing for a wrist operation when a test showed that the major artery carrying blood through his stomach was at high risk of rupturing.

Hall and his wife first thought of going to the Department of Veterans Affairs for treatment.

"Then my brain clicked on that we were near the Mayo Clinic," said Val Hall, Ron's spouse. "And we got referred there."

Hall became to the first person in the United States to receive an experimental device that shored up a bulge in his abdominal aorta. But what happened to him could only have occurred at a handful of medical facilities across the country.

Those places have government permission to perform early feasibility studies on the TAMBE abdominal aortic stent, a product made by W.L. Gore and Associates that the FDA finds promising, but has not yet judged safe and effective.

Early feasibility studies are reserved "for a small number of high risk patients who don't have a good alternative choice," Oderich explained.

For Ron Hall, it was a godsend. His abdominal aortic aneurysm was so big doctors said "it could cause me to tip over any minute and die," recalled Hall, a retired structural steelworker and truck driver.

Oderich and his Mayo team used small incisions in Hall's groin and left arm to insert a specially designed stent in his abdomen that lined his aorta and kept blood flowing without the risk of blowing open a 9-centimeter weak spot.

Hall spent three days in the hospital and emerged healthy. Last week he had a minor outpatient revision to unkink an artery in his kidney and is well on the way to complete recovery. The maker of the stent, Arizona-based Gore paid for the device, as well as Hall's medical expenses.

Hall was the first of 10 patients the doctor has permission to implant with the new Gore stent. The company will pay for the implantation of all of them. Hall and Oderich both know they are lucky.

"I'm fine," Oderich said. "But the vast majority of cardiac surgeons and vascular surgeons do not have access to this technology. So they improvise. They do stents off-label. The things that they do are unbelievable sometimes, and of course the failure rate of that is higher."

American device makers, including many in Minnesota, frequently complain that cutting-edge medical products are approved for use in Europe before they become available to American patients.

In response, the FDA enhanced its early feasibility study program in 2013. The agency "increased focus on these studies … and also outlined some new tools for effectively developing those studies and supporting their approval," an FDA spokeswoman told the Star Tribune.

The government "believes that if the early stages of clinical evaluation of a device are conducted in the U.S., then the FDA and U.S. clinical investigators will become familiar with the device earlier than they would have otherwise," the spokeswoman explained. "This is likely to promote earlier U.S. approval and conduct of later stage clinical studies that are designed to support premarket approval."

From 2013 to June 30, 2015, applications for early feasibility studies rose from 22 to 33. In the same period the number of approved applications increased from nine to 22.

For those initially turned down, the FDA instituted an immediate feedback initiative that required the agency to meet in person or by teleconference within 10 business days of refusal.

"In 2015, over 73 percent of [early feasibility studies] were approved within two review cycles," the FDA spokeswoman said.

For device makers like Gore, the FDA's approach represents a chance to market products commercially in the U.S. in a fraction of the time it once took.

"We got into this assuming it would save us years [in the time it takes to get FDA commercial approval]," said Ryan Takeuchi, a leader in Gore's aortic products group. "It used to be we couldn't do early feasibility studies in the U.S. So a lot of manufacturers would go outside."

Now, Gore has an early feasibility study for the stent Oderich implanted in Hall ongoing at multiple sites. In addition to Mayo, the device is being used experimentally at the University of Pittsburgh, Dartmouth College, University of North Carolina, Mount Sinai Hospital in New York and Washington University in St. Louis.

Oderich is also testing other aortic abdominal stents made by Gore and Indiana-based Cook Medical in larger, later-stage feasibility studies that will hopefully reinforce proof of their effectiveness and give rise to pivotal clinical trials which the FDA requires to pronounce devices safe and effective for commercial sale.

For research doctors like Oderich, early feasibility studies offer a chance to save lives or ease suffering not only by testing devices, but by polishing protocols.

Using a three-dimensional printer to make a model of Hall's abdominal aorta, Mayo team members simulated their operation the day before it actually took place. Oderich also uses simulated surgery to prepare for implanting other experimental stents.

Mayo has even reversed the process as a teaching tool. Oderich has the clinic's resident physicians in training and doctors from South America watch actual surgeries, then try to duplicate them in 3-D simulation the next day.

Ultimately, all the experimentation aims to make devices available sooner to the entire U.S. population so that patients like Ron Hall no longer risk their lives on the vagaries of a hospital choice.

"If this type of early feasibility becomes more frequent," said Oderich, "you will drive development of devices forward and bring technology earlier to physicians in the United States."

Jim Spencer • 202-383-6123