Boston Scientific Corporation
(
BSX
) recently announced that it has successfully treated the first
patient under the ZERO AF clinical trial. This international,
multi-center study is used to evaluate the performance of the
Blazer Open-Irrigated Temperature Ablation Catheter in patients
with symptomatic, drug refractory paroxysmal atrial fibrillation
("PAF").
The result of this trial, which includes 472 patients in 33
sites across the U.S., Europe and Asia-Pacific, is expected to be
used to support a regulatory submission to the U.S. Food and Drug
Administration ("FDA") for a PFA indication. While Blazer
Open-Irrigated Catheter is approved for use in CE Mark countries
and Canada, it is yet to receive approval in the U.S. This latest
addition to the company's Blazer catheters product line is Boston
Scientific's first open-irrigated catheter with a design to cool
the entire tip of the electrode during radiofrequency energy
delivery.
Atrial fibrillation is a rapid irregular rhythm affecting the
upper chambers of the heart. This disorder is increasingly
affecting nearly 15 million people globally, leading to
complications like stroke or heart failure. Moreover, patients
treated with anti-arrhythmic drugs often experience adverse side
effects. In such cases, Catheter ablation is being used
increasingly.
Revenues from Boston Scientific's Electrophysiology business
during the latest quarter were $35 million, down 2% on a
year-over-year basis. The worldwide flat sales were due to the
softness in both the small tip and large tip U.S. businesses,
offset by growth in other segments including capital equipment,
cooled ablation and diagnostics. However, in Oct 2012, Boston
Scientific acquired Rhythmia Medical, Inc., which develops
next-generation mapping and navigation solutions for use in
cardiac catheter ablations and other electrophysiology
procedures, including atrial fibrillation and atrial flutter.
This acquisition is expected to strengthen the company's
foothold in the electrophysiology ablation business.
However, the challenges at Boston Scientific's core segments
consisting of stents and defibrillators do not show any signs of
abatement in the near term. The company continues to experience
pricing pressure in the U.S. and Europe. Additionally, the
softness in procedural volume due to economic uncertainties and
competitive product launches remain concerns. This has affected
other players in the MedTech sector as well, such as
Medtronic
(
MDT
) and
St. Jude Medical
(
STJ
).
Despite the various ongoing headwinds, product launches made
in the recent past should provide some cushion to its top line.
Several other products are slated for launch over the year, which
should benefit the top line.
We have a Neutral recommendation for Boston Scientific. The
stock retains a Zacks Rank #3 (Hold).
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