Bruising battle shaping up in stents

Reports from a major meeting of cardiologists this week suggest a shift may be on the way in the market for drug-coated heart stents.

Both Fridley-based Medtronic Inc. and Boston Scientific Corp. introduced results from separate studies indicating their next-generation stents are superior to older versions.

Wells Fargo analyst Larry Biegelsen said in a note to investors that the evidence suggests that Medtronic and Boston Scientific's products could account for 21 to 23 percent of the $3.8 billion worldwide market by 2014.

That means Illinois-based Abbott Laboratories' recent domination of the market will come under fire.

Stents are tiny metal sleeves that prop open clogged heart arteries. When coated with drugs, vessels are less likely to reclog.

Medtronic's stent, called Resolute, is the new version of its original Endeavor product. The stent is designed to release its drug into the body more slowly, preventing the artery from renarrowing and minimizing repeat treatments.

The company's study involved 1,402 patients in the United States and found that 4.7 percent treated with the newer stent died for heart-related reasons, suffered a heart attack or needed retreatment within a year. The older Endeavor stent had a 6.5 percent rate of complications.

The companies are presenting the data at the American College of Cardiology meeting in New Orleans.

The Resolute stent is not yet available in the United States, but data from the study released Monday will be used to bolster the company's submission to the Food and Drug Administration (FDA) for approval. Medtronic says the FDA's decision is expected in the first half of 2012.

Morgan Stanley analyst David Lewis said investors continue to "underappreciate the market potential" of the Resolute stent. "First-generation Endeavor was largely relegated to a niche market," he wrote, "but we believe Resolute will compete squarely" with rival stents from Boston Scientific and Abbott.

The news failed to move Medtronic's stock Monday -- shares closed at $39.43, down 7 cents.

A separate study involving 1,530 patients showed Boston Scientific's next-generation Promus Element stent is similar to earlier iterations of the device. The original version of Promus is identical to Xience, the market-leading stent made by Abbott -- part of a licensing agreement struck by the two companies when Boston Scientific bought Guidant Corp. in 2006.

Death from cardiac causes, heart attacks and retreatment occurred in 3.4 percent of patients with the new Promus Element stent, compared with 2.9 percent of those treated with the older device. Rates of deadly clots in patients were identical at 0.4 percent, with re-treatment in 1.9 percent of patients in both groups.

Showing similar clinical results to the existing Promus stent is important to Boston Scientific because the company's supply agreement with Abbott ends in mid-2012, analysts said. After that, the company will have to produce its own version of the product.

Monday's study results will be used to pursue regulatory approval in the United States -- where the domestic market for drug-coated stents is now valued at more than $2 billion, according to the Millennium Research Group.

Leerink Swann analyst Rick Wise said clinical results should "ease investor anxiety about [Boston Scientific's] ability to achieve FDA approval for Promus Element and successfully transition its Promus sales to Element."

Boston Scientific's stock closed Monday at $7.23, down 7 cents.

Dr. Martin Leon, of Columbia University/New York Presbyterian Hospital and lead researcher in the Medtronic study, said cardiologists will determine which device to use in patients based on subtle differences and personal preference. He compared the products to luxury automobiles made by Audi and BMW.

"It's tough," he said. "These are all best-in-class."

Bloomberg News contributed to this report. Janet Moore • 612-673-7752