Medtronic
(
MDT
) 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
) 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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