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Medtronic's Resolute Now in Japan

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Medtronic (MDT - Free Report) has strengthened its drug eluting stent (“DES”) portfolio with the launch of Resolute Integrity in the world’s second largest medical device market, Japan. The device received regulatory and reimbursement approvals earlier this year based on data from the RESOLUTE Japan study.

The RESOLUTE Japan study had enrolled 100 patients at 14 Japanese medical centers between March and October 2009. The two-year results from that study demonstrated the durability of the treatment using Resolute DES. The Resolute Integrity DES was launched in the US in February 2012 and in Europe in August 2010.

During the recently reported first quarter 2013 results, Medtronic reported a 36% rise in DES sales (at constant exchange rate), driven by Resolute Integrity’s share gain of 7 points in the US market, thereby nearly tripling its market share over the last two quarters. With the launch of Resolute Integrity in the $500 million Japanese DES market, Medtronic is gearing up to replicate its success already achieved in the US market , by doubling its market share.

In another development, earlier this week, results from the PROTECT clinical trial were presented for the first time at a conference. Data from the study, conducted with over 8,700 patients across 196 centers in 36 countries, confirmed the long-term safety of DES in the treatment of coronary artery diseases in real-world clinical practice.

The aim of the trial was to evaluate the occurrence of stent thrombosis, the formation of a blood clot inside the stent, which is often associated with serious clinical events, such as cardiac death and heart attack. This trial was conducted following a recommendation from the US Food and Drug Administration in 2007. According to the agency, elaborate studies should be conducted to assess the risk of infrequent events, such as stent thrombosis.

Patients in the PROTECT trial were randomly assigned to receive either Medtronic’s Endeavor zotarolimus-eluting stent or Johnson & Johnson’s (JNJ - Free Report) Cypher sirolimus-eluting stent in equal numbers. During the three years of follow-up, the rate of stent thrombosis was low with no significant difference in the two cases (1.42% for Endeavor and 1.79% for Cypher). However, stent thrombosis with Endeavor (0.3%) was significantly lower compared to Cypher (1.1%) after one year.

We have a Neutral recommendation on Medtronic. The stock retains a Zacks #3 Rank (Hold) in the short term.

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