) receipt of the US Food and Drug Administration (FDA) approval
for its longer sized Resolute Integrity drug-eluting stent (DES)
with an indication for patients with diabetes, recently the
company again received CE Mark approvals for a favorable labeling
update on the Resolute Integrity DES with new information on dual
antiplatelet therapy (DAPT). The approvals reflect that the
company is working in the right direction to strengthen its
According to the updated label, interruption/ discontinuation
of dual antiplatelet therapy
any time after one month of stent implantation, involves low risk
and no increased risk for stent thrombosis. The CE Mark approval
was the result of a one year independent analysison DAPT.
The analysis considered 5,000 patients with implanted stents
from the global RESOLUTE Clinical Program. The study showed that
the first 30 days of the implant procedure involves greater risk
of stent thrombosis due to DAPT interruption. However, as this
one-month period is over, the risk reduces with no increased risk
for cardiac death or target vessel myocardial infarction.
Medtronic's focus on portfolio upgrade and expansion is
inevitable in the face of severe headwinds in its core segments
of stents and defibrillators. Other players in the medical
devices space such as
St Jude Medical
) are also resorting to various alternatives to revive their
flagging top line.
In this regard, we note that earlier Boston scientific
received CE Mark approval for a label change showing low risk
after three months of dual antiplatelet therapy. This leading
major also received approval from the FDA for longer lengths of
the Promus Element Plus stent.
Despite headwinds such as unfavorable currency movement and
global economic uncertainties, Medtronic is enjoying market share
gain on the back of the Resolute Integrity drug-eluting stent
under the CardioVascular franchise. Given the burgeoning diabetic
population in the U.S., the approval should drive utilization
rates. Acceptance of the new sizes of the stent should bolster
growth of the franchise for the company.
Estimate revision trend for Medtronic's ongoing and next
fiscal reflects a glaring lack of clarity. Accordingly, the stock
carries a Zacks Rank #3 (Hold). While we have a non-committal
stance on Medtronic, one of the medical stocks carrying a
favorable Zacks Rank is
). This stock carries a Zacks Rank #1 (Strong Buy).
BOSTON SCIENTIF (BSX): Free Stock Analysis
CYBERONICS INC (CYBX): Free Stock Analysis
MEDTRONIC (MDT): Free Stock Analysis Report
ST JUDE MEDICAL (STJ): Free Stock Analysis
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