Nearly 40 years after she injured her ankle in a skiing accident, Ginny Gross found herself so hobbled by arthritis that she was nearly unable to walk.
The ankle pain got so bad that Gross, 69, of Edina, finally resorted to a surgical fix in June 2008.
She passed up the more common fusion surgery, opting for an operation to implant an ankle replacement device that promised both pain relief and more mobility than traditional procedures.
More than two years later, Gross credits the device for allowing her to work in a doctor’s office, climb apartment stairs and pursue hobbies like hula-hoop lessons and rollerblading.
“I felt myself aging quickly because I couldn’t do the things I wanted to do — the pain was so bad,” Gross said. The procedure, she added, “gave me my life back.”
When patients praise joint-replacement devices, they usually aren’t talking about products from firms in the Twin Cities. But Gross and a growing number of patients can track their artificial joints to the Edina headquarters for a company called Tornier.
The European manufacturer of artificial joints has operated out of France for most of its 65-year history. But new owners in 2006 moved the Tornier headquarters to the Twin Cities to take advantage of local executive talent and create a larger presence in the U.S. market for medical devices.
Thanks to the move, the local economy has a stake in the growing market for orthopedic implants used in the extremities — small joints such as ankles, shoulders, wrists and elbows. From a growth perspective, the opportunity is a promising one, analysts say, although implant manufacturers still face challenges.
“It’s one of the faster-growing markets in orthopedics,” said Jan Wald of Noble Financial. “None of the big guys have done a lot in extremities, yet. I expect they will, because they are trying to pursue markets that are faster-growing.”
Large orthopedic device companies have been focused on the much larger markets for replacement hips and knees, which posted a combined $12.2 billion in sales during 2008, according to PearlDiver, an Indiana-based market research firm. The extremities market was much smaller, with revenue of just under $1 billion.
PearlDiver projects extremities sales will grow to $1.5 billion by 2012, with Tornier holding the No. 2 market-share spot behind DePuy Orthopaedics, a subsidiary of medical products giant Johnson & Johnson.
The Twin Cities boasts one of the largest clusters of medical device companies in the nation, but artificial joints have never played a big part in the local story. Instead, much of the artificial joint industry is clustered in a small town in northern Indiana called Warsaw.
“To understand why Minneapolis is not a hub, you have to understand why Warsaw is,” said Doug Kohrs, chief executive officer of Tornier and a veteran of medical device companies in the Twin Cities.
Warsaw is where Revra DePuy founded an orthopedic appliance firm in the late 19th century that eventually became DePuy Orthopaedics. Executives left DePuy over the years to start rival firms, and two of the leading competitors in the hip and knee business — Zimmer Holdings Inc. and Biomet — set up shop in Warsaw.
It’s not unlike what happened with the heart-device industry in the Twin Cities, which got started with Fridley-based Medtronic and snowballed as former executives started companies nearby.
“Innovation gives birth to more innovation, and that’s a lot of the reason you have a strong background in cardiovascular here in the Twin Cities,” said Mark Summers, chief executive of ThreeWire, a patient-marketing firm in Eden Prairie. “The orthopedic business grew up in Warsaw for the same reason the cardiac-rhythm business grew up here.”
With Tornier, the Twin Cities is not about to eclipse Warsaw. The private company, which doesn’t release financial information, employs about 50 people here and does all manufacturing in France and Ireland. But the extremities market is seeing healthy growth, particularly when it comes to shoulder implants, said Aarti Shetty, an analyst with Frost & Sullivan.
A procedure known as a reverse shoulder replacement was introduced in the U.S. in 2004, at which point there were about 2,000 such procedures in the U.S. each year. By the end of 2009, the number of procedures had grown close to eightfold, Shetty said.
Tornier competes in the market with DePuy, Biomet and a Florida company called Exactech.
Market growth has been limited by the fact that patients can try to cope with shoulder pain with medication and smaller surgeries, Shetty said. But sales should pick up as more surgeons are trained in the procedure.
“It is designed in particular for use in shoulders that have a deficient rotator cuff and arthritis or complex fractures, as well as other difficult shoulder reconstructions,” Shetty said of the implant. “We are seeing (sales) grow at a much faster pace than even two years ago.”
Growth in the ankle replacement market faces an additional challenge: a lack of reimbursement by some health plans.
Insurers in Minnesota, for example, offer a mixed bag of coverage for ankle replacement procedures. But national carriers such as Cigna and Aetna regard the procedures as experimental, saying the evidence in support of the devices is not yet strong enough.
That’s even with FDA’s clearance last year for an ankle replacement device that was subjected to the agency’s most rigorous approval process.
“This device offers another treatment alternative to fusion surgery and more closely imitates the function of a natural ankle,” said Dr. Daniel Schultz, then the director of the FDA’s center for medical devices, in a statement about the STAR Ankle, which is made by New York-based Small Bone Innovations Inc.
The STAR Ankle joined products from Tornier, DePuy and Texas-based Wright Medical in the U.S. market for ankle replacement devices. Still, some remain hesitant.
“This procedure can have very serious adverse events and requires tremendous technical skill,” said Diane Robertson, director of health technology assessment for ECRI Institute, a Pennsylvania-based group that follows medical device safety issues. “There is evidence to suggest a significant learning curve is associated with achieving optimal outcomes.”
Proponents of the devices acknowledge the need for technical skill but maintain that devices in the right hands can bring significant relief to patients.
Ankle replacement devices have been slower to catch on than hip and knee replacements because of the complexity of the implant procedure, said Dr. J. Chris Coetzee, a foot and ankle specialist in Eden Prairie.
There are 27 bones in the foot below the ankle, so the foot must be well balanced to make the ankle replacement even possible, he said. Plus, balancing ligaments around the ankle is a tougher task than dealing with ligaments around the hip or knee.
“Without good ligament balance, the ankle replacement will not work,” Coetzee said.
The first generation of ankle replacement devices arrived in the 1970s, Coetzee said, and the products now are in their third iteration. Despite the improvements, very few doctors use the implants, and the vast majority of patients still undergo fusion surgeries.
Coetzee is a paid consultant to both Tornier and DePuy. A database of financial disclosure information maintained by Park Nicollet Health Services says Coetzee received consulting fees, research money and travel reimbursements during 2009 worth between $15,000 and $105,000 from the two companies.
Coetzee said the financial relationships don’t affect his judgment when it comes to selecting devices — he uses products from both companies and has undergone training to use those of other manufacturers. Nor does the money prompt him to push patients into ankle replacements.
“I still have 20 years to go before I can retire, so I don’t plan to do ill-advised surgeries,” Coetzee said. “My objective is still to do the best for every patient’s individual situation, whether it is a fusion or replacement. … (And) I plan to do the ankle replacement that is best for each individual, irrespective of my consulting arrangements.”
The goal is to wind up with more stories like that of his patient Ginny Gross, the Edina woman who received a replacement ankle two years ago.
Gross said the range of motion with the device is about 75 percent of the motion in her good ankle. She’s not able to run or jump on the ankle and has stayed away from skiing. But life with the replacement is much better than it was before, Gross said.
She goes dancing, takes walks, stays busy at work and wears a 2-inch heel when she wants to.
“It’s a wonderful thing,” Gross said. “It has absolutely changed my life.”
Christopher Snowbeck can be reached at 651-228-5479.
