Boston Scientific Corporation
) announced receipt of the CE Mark approval of its X4 line of
quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4,
and INOGEN X4 cardiac resynchronization therapy defibrillators
(CRT-Ds), a suite of ACUITY X4 quadripolar LV leads and the
ACUITY PRO lead delivery system. Leads are the wires that connect
defibrillators and pacemakers to the heart.
The ACUITY X4 suite of quadripolar LV leads is uniquely designed
with multiple electrode spacing configurations to accommodate
individual patient anatomy. The 3D spiral further maximizes
electrode contact with the myocardium and minimizes pacing
capture thresholds in non-apical locations. More importantly, the
multiple fixation option of the device assist the medical
professionals reach the difficult vessels, which were
inaccessible till now, by other available quadripolar leads.
Extensive observation and research done by the World Health
Organization (WHO), has led to the finding that 80% of the
premature heart disease and stroke is preventable. Therefore, it
is believed that that the new offering will act as a boon for the
patients and help save lives.
The vital approval opens the scope for commercialization of the
medical device across Europe. It is believed that the Cardiac
Rhythm Management (CRM) business of the company will considerably
gain from the new approval as the segment is slowly returning to
The first implant of the AUTOGEN X4 CRT-Ds was successfully
accomplished in Civili Hospital, Brescia, Italy. According to the
WHO, Cardiovascular disease (CVD) account for more than half of
all deaths across the European Region.
The CE Mark ensures wide recognition of the product throughout
the European region. The important approval is also expected to
enhance greater adoption as both medical professionals and
patients can rely on the effectiveness of the product.
Boston Scientific further announced that following the CE mark,
it plans to start a global clinical study of the same covering
Currently, the stock carries a Zacks Rank #2 (Buy). Investors
interested in the medical products industry can look into stocks
Hill-Rom Holdings, Inc.
Mead Johnson Nutrition Co.
). While Hill-Rom sports a Zacks Rank #1 (Strong Buy), NuVasive
and Mead Johnson holds a Zacks Rank #2 (Buy).
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