Bulging market for aortic stents
The Minneapolis Star Tribune
January 16, 2011
Medtronic is among a number of companies with new products for a type of aneurysm that can be deadly if it bursts.
By Janet Moore, Star Tribune
Gene Sandvig had no clue that a silent killer lurked within his trim 79-year-old body.
The former Olympic speed skater still considered himself to be in good shape, thanks to lifelong commitment to fitness and a fervent love of golf. But during an annual checkup last year, his doctor suggested he get screened for an abdominal aortic aneurysm, or AAA, a weakness in the wall of the aorta not uncommon in men over 60.
Good thing. The Edina grandfather had a bulge in his aorta -- the body's biggest artery -- that was three times its normal size. Had it burst, chances of survival were slim.
"Then that would have been the end of me," Sandvig said, matter-of-factly. "So I needed to go in and get it taken care of."
For years, these aneurysms were treated with surgery, a long hospital stay (up to two weeks) and an even-longer recovery. But, increasingly, doctors are using a minimally invasive treatment that involves inserting a stent inside the aortic bulge through an artery in the groin. A one-day hospital stay is pretty standard afterward, and recovery much swifter.
"The old-fashioned way works well, but it was quite an ordeal. The risks associated with surgery are so much higher, and the recovery dramatically longer," said Dr. Steven Santilli, a vascular surgeon with University of Minnesota Physicians.
It helps that doctors have several newfangled stents from which to choose. Last December, the Food and Drug Administration (FDA) approved the Endurant AAA Stent Graft System from Fridley-based Medtronic Inc., which the company claims is easier to use than competing devices.
Already a market leader in aortic stents, Medtronic immediately began rolling out its new product in the United States -- and Sandvig was among the first recipients last week at the University of Minnesota Medical Center, Fairview.
As is often the case in medical technology, the field is highly competitive. W.L. Gore & Associates said last week it began using a new aortic stent delivery system recently approved by the FDA -- a technology the company claims is "game-changing." Other competitors in the market include Indiana-based Cook Medical and Endologix Inc. of Irvine, Calif.
"There's been a lot of evolution in the [aortic stent] market, " said Tim Nelson, an analyst with FAF Advisors. "It's been a great success story -- here's a minimally invasive technology that turned out to be better."
Currently, the market for aortic stents is about $675 million, according to Millennium Research Group, a Toronto-based research firm. But technological advances developed by both new and veteran players in the field will expand the pool of potential patients and make it easier for doctors to use the devices, the firm said in a recent report. This will drive further market penetration and revenue growth through 2015.
This is good news for device manufacturers since sales of cardiac stents, a onetime blockbuster in med-tech, have slowed considerably in the past two years for makers Boston Scientific Corp., which employs 5,000 in Minnesota; Johnson & Johnson; Abbott Laboratories, and Medtronic. Healthier growth is expected for stents used in other parts of the body, including the legs, carotid arteries -- and the aorta.
But a vexing challenge remains for makers of aortic stents. While the potential market is large -- Medtronic estimates that 1.2 million Americans have abdominal aortic aneurysms -- screening potential patients is challenging because they may not experience any symptoms and don't know they need a simple ultrasound screening. In fact many abdominal aortic aneurysms are found by happenstance.
But public awareness has been growing. In 2005, then-President George W. Bush signed into law provisions that call for Medicare to reimburse screenings for men with risk factors for AAA, including high blood pressure, high cholesterol, a history of smoking and heart disease. And several celebrities, including football legend Joe Theismann and Olympic hockey champion Jim Craig, have spread the word about the condition. Theismann's campaign is sponsored by Medtronic.
As Sandvig lay unconscious in an operating room last Monday, doctors made a small incision in his groin maybe an inch long. Nurses prepared for the procedure by removing the 4-foot-long Endurant stent system -- which looked like a sophisticated fishing rod to one observer -- from its packaging. Each device costs $15,000 to $20,000; two stent systems were used in Sandvig's procedure.
A wire, and then a catheter loaded with a compressed metal and fabric stent, were snaked through Sandvig's femoral artery to his aorta. Using the motor skills and steely nerve of an avid video gamer, Santilli steered the catheter inside the body by twisting an external lever while following the stent's progress on a nearby computer screen.
Once in the right spot, the thick-as-a-thumb stent was carefully released into the aorta. The deployed device created a new pathway for blood within the bulging vessel and two iliac arteries. A second stent was used on the left iliac artery.
All told, the procedure lasted a little more than an hour. Sandvig remained in the hospital Monday night and went home the next day.
"He's a little sore," his wife, Carolyn, reported. "But he's fine."
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