Heart stent market gets more crowded with European clearance

Medtronic said Sunday that it had received its long-awaited clearance from European regulators to market its drug-coated Endeavor heart stent.

The approval opens the door for Medtronic to compete with Boston Scientific and Johnson & Johnson in one of the medical device industry's largest and most lucrative markets. It also clears the way for Medtronic to begin marketing Endeavor in many other countries that follow Europe's regulatory lead on medical devices, including Singapore, Malaysia, South Africa, Mexico and several Persian Gulf nations.

"We will hit the ground Monday very aggressively in 40 countries," said Rob Clark, a spokesman for Medtronic, which is based in Minneapolis.

Stents are metal mesh sleeves inserted into coronary arteries to prop them open after blockages have been cleared. In recent years, bare metal stents have rapidly been displaced by so-called drug- eluting stents from Boston Scientific and Johnson & Johnson. The stents are coated with polymers infused with drugs. The drugs slowly seep into the vessel walls to combat a process called restenosis in which tissues in the vessel walls grow through and around bare metal stents, forming new blockages.

Drug-eluting stents have become a $5 billion market, and some analysts project that sales will top $9 billion by the end of the decade. They cost around $2,300 in the United States, two to three times as much as the bare metal devices, but they have quickly claimed close to 90 percent of the domestic coronary stent market.

The market penetration is considerably lower overseas because government-controlled health providers have been reluctant to quickly embrace the claims of the device makers that the drug- eluting stents save money in the long run.

Medtronic said the European approval would allow it to begin marketing Endeavor in every major European country except France, where reimbursement hearings are needed.

Analysts expect Medtronic to gain less than 10 percent of the European market this year but as much as 25 percent in the long run. Medtronic does not expect to gain approval to market Endeavor in the United States until 2007.

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