St. Jude Medical Inc.
) revealed that it has initiated post-approval trial for the
Nanostim leadless pacemaker in order to evaluate the Nanostim
leadless pacing technology. In this LEADLESS Pacemaker
Observational Study, St. Jude Medical will enroll about 1,000
patients in nearly 100 centers in Europe.
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Nanostim pacemaker obtained CE Mark approval in 2013. After its
approval, the pacemaker has been implanted in patients located in
the U.K., Germany, Italy, Czech Republic, France, Spain, and the
The study aims to provide evidence about the safety profile of
the Nanostim leadless pacemaker in patients subjected to
ventricular single chamber pacing. It will also present long-term
data about the leadless pacemaker and provide additional
information about the long-term performance of the device.
What Is So Different About This Pacemaker?
The Nanostim leadless pacemaker measures less than 10% of the
size of a conventional pacemaker and can be implanted directly
into the heart by a non-surgical procedure (through femoral vein
with a steerable catheter), unlike conventional pacemakers, which
require a more invasive surgery.
The pacemaker can be placed without the visible surgical pocket,
scar and insulated wires (known as leads) needed for conventional
pacemakers. It can be fully retrieved so that it can be readily
repositioned throughout the implant procedure.
The smaller size and absence of a surgical pocket and a lead make
the pacemaker comfortable for patients, reducing several
complications, including device pocket-related infection and lead
failure. It allows patients to live uninhibited lifestyles due to
the elimination of the visible lump and scar at a conventional
pacemaker's implant site, apart from the removal of patient
activity restrictions that may prevent the dislodgement or damage
to a conventional lead.
The device is supported by the St. Jude Medical Merlin
Programmer, used to interrogate and program the company's other
pacemakers and implantable cardioverter defibrillators (ICDs).
The device battery is anticipated to have an average lifespan of
more than nine years at 100% pacing, or more than 13 years at 50%
Other Nanostim Clinical Trials
Last year, St. Jude Medical conducted LEADLESS study in order to
evaluate patients with the Nanostim leadless pacemaker. Results
from that study indicated overall performance of the device
comparable to conventional pacemakers and found that total
implant procedure times averaged 28 minutes.
The first U.S. implant in the LEADLESS II pivotal trial, aimed
for U.S. Food and Drug Administration (FDA) approval of the
device, took place only last month. The trial, conducted under an
Investigational Device Exemption (IDE) from the FDA, will enroll
roughly 670 patients at up to 60 centers globally with up to 50
sites in the U.S.
Currently, St. Jude Medical carries a Zacks Rank #3 (Hold). Some
better-ranked stocks in the medical products industry include
). Enzymotec and Stryker Corporation carry a Zacks Rank #1
(Strong Buy), while Covidien holds a Zacks Rank #2 (Buy).