Now that federal regulators have approved a drug-coated heart stent made by Medtronic Inc., doctors and company officials hope the news will reinvigorate a once-blockbuster market that has seriously slumped in the past year.
With safety concerns still lingering marketwide, some say it will. Others say maybe.
"It certainly won't hurt," said David Heupel, a portfolio manager at Thrivent Financial for Lutherans, who follows Medtronic. "Expectations are very high. But I don't think we'll go back to the glory days, where more than 80 percent of [angioplasty] procedures involve a drug-coated stent."
The long-anticipated approval Friday means that Fridley-based Medtronic's new stent, called Endeavor, will go head to head in a $2 billion U.S. drug-coated stent market against rivals Boston Scientific Corp. and Johnson & Johnson. But it will enjoy its competitive advantage for just a short stitch of time -- competing next-generation stents by Abbott Laboratories and Boston Scientific are expected to hit hospital shelves by the end of June.
Stents are tiny mesh struts that prop open clogged arteries leading to the heart. They have proved to be an important salvo in the treatment of heart disease. When the stents are coated with a drug, arteries are less likely to reclog, a fairly common phenomenon with previous-generation bare-metal stents. After Boston Scientific introduced its Maple Grove-made Taxus drug-coated stent in 2004, sales and use of the devices surged.
But the sheen on the product wore off in late 2006, when several studies indicated that a small number of patients using drug-coated stents experienced potentially fatal blood clots. Another study released soon after indicated that older-generation stents were no better at warding off heart attacks and death than drugs.
Many doctors opted to treat patients with bare-metal stents, bypass surgery or drugs, and the drug-coated stent market declined by about 30 percent.
100,000 stents shipped
Medtronic, once seen as a latecomer to the drug-coated stent market, is marketing Endeavor by saying it is easier for doctors to use, and safer. The company has doubled the size of its sales force for the launch -- one of the biggest in the company's history, although executives declined to quantify the number of reps selling the devices. On Friday, Medtronic began shipping approximately 100,000 stents to more than 2,000 hospitals across the country.
The company also won't say how much it is charging for Endeavors, except to say it's similar to competitors' prices. (Existing drug-coated stents sell for about $2,000 and their costs are reimbursed by Medicare and private insurers.)
"This has been a five-plus-year development effort for Medtronic," said Scott Ward, president of Medtronic's cardiovascular business. "It ushers in a new era of growth and innovation for us."
Several doctors say they are anxious to try next-generation stents. "The currently available drug-coated stents are very good and certainly have been an important advance, helping hundreds of thousands -- even millions -- of patients. But they're not perfect yet," said Dr. Chet Rihal, a cardiologist and director of the cardiac catheterization lab at Mayo Clinic in Rochester.
Doctors are "cautiously optimistic that the next-generation stents will get us a little bit closer to the ideal stent," he said.
"These guys love new stuff," said Timothy Nelson, an analyst at FAF Advisors, referring to the type of tech-savvy cardiologists who use stents. Nelson predicts that Medtronic will wrest 20 percent of the U.S. drug-coated stent market by the end of next year. (Other analysts are more conservative, predicting Medtronic will grab about a 15 percent chunk of the market with Endeavor.)
"Anytime you have a new technology introduced, it will revive the market," said Hank Kucheman, senior vice president and president of interventional cardiology for rival Boston Scientific. But with recent safety concerns, doctors also will look at a stent's long-term data before choosing what brand to use on patients, he said. (Taxus has five-year follow-up data, with more than 46,000 patients in clinical trials testing the device.)
New requirements
The news that the U.S. Food and Drug Administration approved Medtronic's stent came as no surprise. In October, an FDA advisory panel of doctors and medical experts recommended approval, and the agency rarely bucks a panel's blessing. In a separate news release Friday, Daniel Schultz, who heads the FDA's device division, said Endeavor will give doctors broader choices when treating the more than 1 million patients who undergo angioplasty each year.
Still, the federal agency is requiring Medtronic to follow at least 5,000 patients for five years after being treated with Endeavor. In addition, the company must launch a study to determine how long patients must take blood-thinning drugs (such as Plavix) and aspirin post-implant, a drug regime that wards off clotting.
Now, patients treated with Endeavor must take both for as long as a year after treatment. This is often problematic, because many patients forget to take their drugs, or stop taking them because of the expense -- roughly $3 to $4 a day.
"Compliance is a huge issue with Plavix," said Dr. Wendy Shear, director of the interventional cardiology department at the Minneapolis VA Medical Center. "If a patient is having cataract surgery or knee surgery, and they stop taking the medication, it can be difficult to get them back on it."
Janet Moore • 612-673-7752
