Medtronic ($MDT) is counting on Japan to help generate further sales growth for its Resolute Integrity drug-eluting stent, now that regulators have approved it for sale there.
Resolute Integrity has been a major driver of Medtronic's sales. The company reported recently that its coronary revenue for the fiscal 2013 first quarter grew 11%, to $433 million. Within this division, drug-eluting stents increased their sales by a whopping 36% on a constant currency basis, something Medtronic credits to Resolute Integrity's U.S. sales.
Japan is a particularly important market, as its the world's second largest for medical devices, the Minnesota company notes. So gaining approval there is a big win for device companies and worth noting. Medtronic threw significant resources into the effort, including the RESOLUTE Japan trial, a prospective, single-arm open label study involving 100 patients and 14 medical centers in Japan through much of 2009. Two-year results indicated the study met its primary endpoint and was superior compared to comparable data from Boston Scientific's ($BSX) Taxus stent. RESOLUTE Japan is part of a global RESOLUTE trial involving 250 sites in 32 countries and 5,130 patients, Medtronic notes.
In Japan, Resolute Integrity will be indicated to treat coronary artery disease. The product is approved for 9 indications in Europe for everything from acute coronary syndromes, to in-stent restenosis and diabetes mellitus. In the U.S., as of May, it was the only drug-eluting stent approved to treat coronary artery disease in diabetic patients.
Many stent manufacturers have focused on expanding both market and indications for their products to boost sales in a highly competitive market.
- read the release
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