Recently, medical devices major
Boston Scientific Corporation
) rounded off patient enrollment for the EVOLVE II trial, to
evaluate its Synergy Stent System.
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The company expected to complete enrollment by the third quarter
of 2013. This is a breakthrough for the company to gain
regulatory clearance from the U.S. Food and Drug Administration
(FDA) for the Synergy Stent System.
The EVOLVE II clinical trial is a randomized, controlled clinical
trial to evaluate the efficacy and patient safety of the Synergy
Stent System for the treatment of atherosclerotic coronary
lesions. Not only will the results from the clinical study
support Boston Scientific's effort to obtain approval in the
U.S., it will also back the company's attempt to gain regulatory
clearance in the high focus Japanese market.
The Synergy Stent System is already available in Europe as it
gained the CE Mark approval in Oct 2012. Positive results from
the erstwhile EVOLVE study fetched the CE Mark approval for the
Following clearance in Europe, Boston Scientific's EVOLVE
II trial commenced in Nov 2012. The study enrolled 1,684 patients
at 125 sites across the globe. These sites are located in the
U.S., Canada, Japan, Australia, New Zealand, Singapore and
Europe. The enrolled patients will be observed for five years.
The principal investigator of the EVOLVE II study believes that
the trial results will support the use of Synergy Stent System
for optimal vessel healing. Built on market leading technology,
the stent is perceived to be the most flexible, conformable and
deliverable drug eluting stent (DES).
We believe that the DES market offers a promising growth
opportunity for Boston Scientific. We note that revenues from the
company's DES business recorded a downfall in the last quarter.
This was mainly due to softness in the U.S. market due to reduced
market share from tough competition and pricing pressure across
We believe successful commercialization of the Synergy stent will
enable Boston Scientific to strengthen its DES product portfolio.
The commercialization of the Synergy Stent System should also
lend some upside against competitive headwinds in the domestic
On the other hand, the DES business continued its robust
performance in emerging markets. Management considers that DES
business can offer the biggest opportunity in the emerging
markets. The combined DES market is estimated at $700 million
with a 20% growth rate. Evidently, Boston Scientific has several
catalysts to tap the lucrative market opportunity in the DES
The stock currently carries a Zacks Rank #2 (Buy). Other Zacks
Rank #2 medical stocks that warrant a look are
LeMaitre Vascular, Inc.
). We believe that
), carrying a Zacks Rank #1 (Strong Buy) is also worth