Medical device major
) recently won the CE (Conformité Européenne) Mark for its
Engager Transcatheter Aortic Valve Implantation (TAVI) System.
The valve with transapical delivery catheter will support aortic
stenosis treatment in patients who are at high or acute risk for
surgical aortic valve replacement (SAVR). While management
anticipated the European launch in the second half of fiscal
2013, the Engager System is not yet available in the U.S.
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Medtronic's latest valve is made of bovine tissue leaflets and a
self-expanding nitinol frame to improve annular sealing which
minimizes chance of paravalvular leak (PVL). It employs a
minimally-invasive delivery system for the treatment through a
catheter placed in the lower, pointed apex of the heart. The
design of the Engager valve ensures optimal blood movement
following the treatment in patients. The company plans to
introduce a direct aortic delivery mechanism for Engager in the
The CE Mark approval was based on affirmative results from the
valve's European Pivotal Trial. Outcomes from the multi-centre
trial demonstrated high rate of procedural success and minimal
PVL at the European Association for Cardio-Thoracic Surgery and
the Society of Thoracic Surgeons annual meetings. Thus, the
latest valve from Medtronic is expected to improve clinical
outcomes for patients with serious aortic stenosis.
Medtronic's consistent expansion of its portfolio via approvals
in the domestic and international market is encouraging. With the
European approval for Engager valve, the company extended its
structural heart portfolio. Medtronic's focus on the structural
heart business is likely to deliver positive results as
substantial adoption of newer products should leverage the top
According to the company, the structural heart business is a
high-focus franchise in the emerging markets, especially China.
Notably, Medtronic's peer in the structural heart business
) is also committed to meaningful portfolio expansion.
New product launches are expected to contribute at least $200
million in fiscal 2014 for Medtronic. However, unfavorable
currency movement, tough competitive landscape and global
economic uncertainties keep us on the sidelines. The stock
carries a Zacks Rank #3 (Hold). However, its peer Edwards carries
a Zacks Rank #2 (Buy). Other Zacks Rank #2 medical stocks are