EV3's tiny metal mesh device acts as "scaffolding" for healing blood vessel.
As physicians, nurses and technicians looked on, Dr. Benjamin Crandall and Dr. Josser Delgado gingerly inserted a catheter into an artery in the leg of a 55-year-old woman.
To guide them, the neuroradiologists watched their progress on several screens showing multiple images of the blood vessels in her brain.
It was her brain -- or, more accurately, a large 1-inch cerebral aneurysm -- that was their destination. The doctors were implanting a tiny, mesh "Pipeline" stent into an artery in her brain behind her right eye. It will allow blood to flow past the aneurysm, a weakened spot in the wall of a blood vessel, and allow it to heal.
The device comes from EV3, a Plymouth-based company that was acquired last year by the Irish company Covidien for $2.6 billion.
Until recently, "giant" aneurysms larger than 25 millimeters in diameter were treated by opening the skull and "clipping" them -- or by placing several small coils into the bulge to stop blood from flowing into them.
But coiling doesn't always work with giant aneurysms. Sometimes, the coils fall out or blood flow pushes them deeper into the aneurysm sac. Untreated, aneurysms can rupture, leading to stroke or death.
An estimated 6 million people in the United States have unruptured brain aneurysms, according to the Brain Aneurysm Foundation.
Since mid-November, physicians with Consulting Radiologists at Abbott Northwestern Hospital in Minneapolis have been inserting the new Pipeline Embolization Device.
Delgado's team at Abbott Northwestern is the only group in the Twin Cities area, and one of only two in Minnesota, implanting the Pipeline device. Nationally, 26 teams are using Pipeline.
"It works like a scaffold, allowing the blood vessel to grow across the weakened area," said Delgado, who said the Pipeline procedure can be completed in as little time as a half hour. "It's a paradigm shift. It's exciting."
Pipeline gained U.S. Food and Drug Administration approval in April 2011 but has been available in Europe since 2009. It is the only device of its kind with U.S. approval.
So far, Pipeline has been a "growth area" for Covidien, said Brett Wall, president of Covidien Neurovascular.
"This device expands treatment for patients with uncoilable aneurysms or aneurysms that failed conventional therapies," Wall said. "It is a technology that provides more options for patients with this serious disease."
One recent weekday, Barbara Lakanen of Coon Rapids was the first of three patients to receive Pipeline at Abbott Northwestern. Delgado and Crandall had inserted the device in eight patients before Lakanen.
Lakanen said she didn't pay much attention to her headaches over the past couple of weeks, other than to note that nothing seemed to help. While visiting her doctor's office to refill a prescription, she mentioned the headaches. Her doctor suggested she get an MRI at an imaging center right across the street.
That was on a Tuesday, Lakanen said. On Wednesday, the doctor's office called to tell her to go to the Abbott Northwestern emergency room right away. A CT scan there confirmed the aneurysm behind her eye, Delgado said.
By 8 a.m. Thursday, Crandall, assisted by Delgado, was snaking the device up through her leg into her brain.
After checking and double-checking measurements and the path to the aneurysm, Crandall placed the tiny chromium and platinum mesh device in the area of the bulge. Within seconds, doctors said, it was working.
On Friday, Lakanen said she was feeling fine. "I saw before and after pictures of my brain, my aneurysm, and it looks terrific," she said. "It's already begun healing."
Doctors told her that the aneurysm had been growing for some time and was likely to keep growing and could eventually cause her to lose sight in her right eye and suffer nerve damage on that side of her face.
Retired from a local medical device company but continuing to work as a consultant, the married mother of four and grandmother of eight said the news was a "bit of a jolt."
"It explains a lot of other things," she said, adding that she tried starting to work out after New Year's Day, only to be derailed by headaches.
"Now I can tell everybody why I quit," she said, laughing. She was released from the hospital a day after the procedure.
If all goes well, now that blood flow has been diverted away from the aneurysm, the artery will probably heal completely in a few months, doctors said. Last week, she was back at work, feeling fine.
James Walsh • 612-673-7428