Boston Scientific stent study meets goal

A new heart stent manufactured by Boston Scientific Corp proved to be as safe and effective as its older model, which is identical to Abbott Laboratories Inc’s market leader, according to a study.

The 1,530-patient study compared Boston Scientific’s drug-eluting Promus Element stent with its older Promus, which is sold by Abbott under the brand name Xience.

Results from the study, called Platinum, showed no significant differences between the two devices in all key measures of safety and effectiveness after one year.

The incidence of stent thrombosis, or blood clots forming in the treated area, occurred in 0.4 percent of patients in both groups.

The incidence of death, heart attack or the need to repeat the procedure was also identical at 1.9 percent.

“On the basis of this study, I would expect the FDA to approve this device in the U.S., which will afford physicians another option of an excellent stent to use,” said Dr. Gregg Stone, from New York Presbyterian Hospital/Columbia University Medical Center, who led the study.

Boston Scientific would prefer to see wider use of the newer model as it must pay royalties to Abbott on the older Promus. If approved, the device is expected to be available in the United States in mid-2012.

Stents are tiny mesh tubes used to prop open arteries that have been cleared of blockages. The Promus Element stent is made of platinum. The earlier version is made of cobalt. Both are coated with the drug everolimus to prevent the formation of scar tissue, which can reclog the treated vessel.

Boston Scientific, which has an estimated 46 percent of the U.S. market for heart stents, has said it expects its gross margins to improve significantly once its new product is rolled out.

“In order to achieve this benefit, the company must be able to convert current buyers of (its old stent sold by Abbott) to Promus Element, a process that is going well in the Europe, Middle East and Africa region,” BMO Capital Markets analyst Joanne Wuensch said in a research note.

However, some analysts do not think physicians will be motivated to switch brands.

“The question on our minds, however, is whether a one-for-one swap-out is in fact achievable given that Element showed only non-inferiority to Xience, Goldman Sachs analyst David Roman wrote in a research note.”

“It seems to us that physicians would opt to stick with the market-leading stent, and we expect competition for the Promus business to be significant,” added Roman, who has a “sell” rating on the Boston Scientific stock.

Boston Scientific shares fell 19 cents, or 2.6 percent, to $7.11 on the New York Stock Exchange in late-afternoon trading, ahead of an analyst meeting it is holding in New Orleans Monday night.

(Reporting by Debra Sherman, Bill Berkrot and Ransdell Pierson; Editing by Matthew Lewis and Richard Chang)

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By Debra Sherman and Bill Berkrot

NEW ORLEANS