Leading medical device player
Medtronic
(
MDT
) recently came out with the results of two studies conducted on
the company's CoreValve System delivered through the direct aortic
implantation approach. The data demonstrated at the 48
th
Annual Meeting of the Society of Thoracic Surgeons (
STS
) showed positive result from this kind of implantation.
Earlier, in November 2011, CoreValve System with direct aortic
implantation approach got the CE (Conformité Européenne) Mark
approval. This direct aortic approach has also been assessed in the
CoreValve US Pivotal Trial of Medtronic.
Data in this regard showed procedural success in 92 of 93
patients treated at 12 centers across Europe. The overall 30-day
mortality rate stood at 9.7%. Among the patients, 83.9% were
initially detected with peripheral vascular disease and almost
one-third underwent previous coronary artery bypass surgery
(indicating significant preoperative risk of mortality with
standard surgery).
A separate study in Italy also illustrated positive outcome of
implantation of the CoreValve System through the direct aortic
approach. The data of 25 patients demonstrated 92% (23 of 25
patients) survival rate at 30 days. None of the patients
experienced strokes and 4 patients were implanted with pacemakers
post-procedurally. All of these patients had previously diagnosed
peripheral vascular disease.
The CoreValve System is designed to replace diseased aortic
valves without undergoing an open-heart surgery. Globally,
approximately 300,000 people have been diagnosed with this
condition and roughly one-third of these patients are deemed at too
high a risk for open-heart surgery. This system is available in
three sizes (26mm, 29mm and 31mm), and is the only transcatheter
aortic valve implantation (TAVI) system approved for direct aortic
implantation.
Although CoreValve is already approved in Europe since 2007,
Medtronic is working on getting the US approval for the device.
Earlier this month, the company completed the enrollment in the
extreme risk category of patients for its CoreValve US Pivotal
Trial.
During the most recent quarter, the company experienced robust
growth in the Structural Heart portfolio, driven by strong adoption
of CoreValve in the international markets. The company is
witnessing strong early adoption of the 31mm CoreValve that
received CE Mark approval in July and anticipates CE Mark approval
for the 23 mm CoreValve in the second half of fiscal 2012.
Recommendation
We are impressed with Medtronic's continuous efforts to achieve
the US approval for CoreValve and expect its further contribution
in the international business as well. A pivotal trial for
CoreValve began in Japan earlier in November.
In October, CoreValve received approval in Korea and the company
is further working to get the device approved in several countries
including the US, Thailand, Singapore, China, Hong Kong and Taiwan.
However,
Edwards Lifesciences
(
EW
) has the first mover advantage in US with FDA approval of Sapien
clinched in November last year.
Medtronic reported weaker sales from its two largest segments -
defibrillators and spinal implants. The challenges witnessed in the
US ICD market have also been felt across the board and impacted
Medtronic's competitors,
Boston Scientific
(
BSX
) and
St Jude Medical
(
STJ
).
To overcome these challenges, Medtronic is leaving no stones
unturned to revive growth. This includes penetration of
international markets, portfolio expansion, focus on high-potential
segments and restructuring initiatives. These should benefit the
company over the long term.
Medtronic currently retains a Zacks #3 Rank (short-term Hold
rating). We also maintain our long-term Neutral recommendation on
the stock.
BOSTON SCIENTIF (
BSX
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EW
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MDT
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STJ
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