Fargo doctor develops new stent graft to fix aneurysmsFARGO – Arlene Olson had a bulge in the aortic artery inside her abdomen that was a ticking time bomb waiting to explode.
By: Patrick Springer, INFORUM
FARGO – Arlene Olson had a bulge in the aortic artery inside her abdomen that was a ticking time bomb waiting to explode.
Not long ago, because of the small size of her artery, the 87-year-old woman would have required open surgery to repair the aneurysm that, if untreated, would eventually rupture and end her life.
At her age, not all patients survive such surgery.
Luckily, thanks to an innovation by her Fargo doctor, Olson received a stent graft in her aortic artery from a “minimally invasive” procedure in mid-July.
“I went home the next day,” she said. “The recovery was good.”
In fact, the Fergus Falls, Minn., woman was the first patient in the United States to receive the device when Dr. Corey Teigen, an interventional radiologist at Sanford Health, inserted the stent – which he invented.
“It’s not much different than an angiogram,” he said.
Teigen, whose specialty includes difficult aneurysm repairs, started developing the new device, which is approved for clinical trials by the Food and Drug Administration, eight years ago.
Earlier, Teigen traveled to Germany to demonstrate insertion of the device, where it was successfully tested. So far, Teigen is the only physician inserting the new stent graft in the United States, but the number of centers will grow.
A colleague in Japan, meanwhile, is inserting the device there. Many of the patients who will benefit are Asians or of Asian descent.
Besides those with small artery size, the smaller stents are needed for patients whose diseased arteries have hardened and narrowed with age.
Although stent grafts to repair aortic aneurysms have been in use since the mid-1990s – Teigen was one of the pioneers – the challenge he has solved is developing one to fit smaller patients.
Teigen’s invention is less than half the size of the standard stent graft used to repair aortic aneurysms.
If approved, he estimates the smaller stent will enable thousands of patients to have descending aortic artery repairs who would not be candidates for the difficult open surgery.
As of this week, Teigen had inserted his stent in seven patients, with another two scheduled. The trials will last until 190 patients in the United States and Japan have received them.
Under the most optimistic scenario, the FDA could grant approval in two years, Teigen said.
Pending final FDA approval, he’s hoping permission will be granted to continue to insert the stents under the “compassionate use” exception in patients for whom there is no alternative but open surgery.
The actual insertion of the devices in patients like Olson is the result of years of arduous work, cooperating with engineers and going through the rigorous FDA approval process.
Along the way, Teigen has devoted much of his spare time, including nights, weekends and vacations, to the initiative, including travel to Minneapolis, Boston and other locations to test the device in animals before human testing began.
“Obviously this is my passion,” he said, adding that he does not hold a patent for the device and will not benefit financially if it is allowed to go on the market.
But Tiegen, a Moorhead native and graduate of Concordia College, finds the effort immensely rewarding.
“I’ve already treated people I probably couldn’t have treated with any other devices,” he said. “That’s the gratification for me.”
Olson is grateful she no longer has to fear her abdominal aortic artery rupturing.
“No worries,” she said. “I’m doing great. I feel good.”
Readers can reach Forum reporter Patrick Springer at (701) 241-5522