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CE Mark for Medtronic's Engager

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Medical device major Medtronic Inc. (MDT - Free Report) 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.

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 future.

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.

Our Take

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 line.

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 Edwards Lifesciences (EW - Free Report) 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 Covidien and Conceptus .

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