St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced the first post-approval implant of the Nanostim™
leadless pacemaker in the U.K. The world's first retrievable leadless
pacemaker was implanted at St. Bartholomew's Hospital in London by
Professor Richard Schilling.
The Nanostim™ leadless pacemaker is less than 10 percent the size of a conventional pacemaker (Photo: Business Wire)
The Nanostim leadless pacemaker is designed to be placed directly in the
heart without the visible surgical pocket, scar and insulated wires
(called leads) required for conventional pacemakers. Implanted via the
femoral vein with a steerable catheter, the device offers a
less-invasive approach for physicians compared to traditional pacemaker
procedures that require more invasive surgery. The device is designed to
be fully retrievable so that it can be readily repositioned throughout
the implant procedure and later retrieved if necessary.
Maureen McCleave, a 77-year-old from Chingford, became the first person
in the U.K. to receive the Nanostim device. Having dealt with persistent
atrial fibrillation for over a decade, Maureen often experienced periods
of dizziness and fatigue that prevented her from participating in
routine activities. In some extreme cases, her abnormal heart rhythm
resulted in episodes where her heart would stop beating for up to five
seconds at a time. Maureen's procedure took just eight minutes to
perform; she is already feeling more energetic and is looking forward to
a full recovery.
"Nanostim is one of the most significant advancements in cardiology and
pacemaker technology," said Professor Schilling, consultant at Barts
Health NHS Trust. "This miniaturized, minimally-invasive cardiac
pacemaker offers my patients the potential for reduced complications
like infection and aesthetic benefits over conventional pacemakers, in
addition to quicker recovery times. We are delighted to have conducted
the first implants of this ground-breaking technology at St.
Bartholomew's Hospital in the U.K."
The Nanostim leadless pacemaker is less than 10 percent the size of a
conventional pacemaker. The small size of the device and ack of a
surgical pocket, coupled with the exclusion of a lead, improves patient
comfort and can reduce complications, including device pocket-related
infection and lead failure. The elimination of the visible lump and scar
at a conventional pacemaker's implant site, in addition to the removal
of patient activity restrictions that may prevent the dislodgement or
damage to a conventional lead, will potentially improve the quality of
life for patients with this technology by allowing most to continue
living active, uninhibited lifestyles. The device is supported by the
St. Jude Medical Merlin™ Programmer, which is also used to interrogate
and program the company's other pacemakers and implantable cardioverter
"The first post-approval implant in the U.K. is an important step for
this revolutionary technology platform and a proud addition to St. Jude
Medical's strong history in pacing innovation," said Paul Turner, vice
president of St. Jude Medical U.K. "By providing a smaller, leadless
pacing technology, physicians will now be able to offer patients a
device that upholds the accuracy of conventional pacemaker technology
via a minimally invasive procedure. We are pleased to offer this novel
cardiac pacing technology to physicians and patients in the U.K."
Initial results from the LEADLESS study, a prospective, single-arm,
multicenter study evaluating patients with the Nanostim leadless
pacemaker, were presented earlier this year and demonstrated overall
device performance comparable to conventional pacemakers. Total implant
procedure times averaged 28 minutes. Even with miniaturization, the
device battery is expected to have an average lifespan of more than nine
years at 100 percent pacing, or more than 13 years at 50 percent pacing.
Cardiac pacemakers are used to treat bradycardia, which is a heart rate
that is too slow. These devices monitor the heart and provide electrical
stimulation when the heart beats too slowly for each patient's specific
physiological requirements. More than 4 million people worldwide have an
implanted pacemaker or other cardiac rhythm management device, and an
additional 700,000 patients receive the devices each year.
The Nanostim leadless pacemaker recently received CE Mark approval and
is now available in select European markets. The Nanostim leadless
pacemaker is not available for sale in the U.S.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to
transforming the treatment of some of the world's most expensive,
epidemic diseases. The company does this by developing cost-effective
medical technologies that save and improve lives of patients around the
world. Headquartered in St. Paul, Minn., St. Jude Medical has four major
clinical focus areas that include cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit sjm.com
or follow us on Twitter @SJM_Media.
This news release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve
risks and uncertainties. Such forward-looking statements include the
expectations, plans and prospects for the Company, including potential
clinical successes, anticipated regulatory approvals and future product
launches, and projected revenues, margins, earnings and market shares.
The statements made by the Company are based upon management's current
expectations and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those described in
the forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company's control and the
risk factors and other cautionary statements described in the Company's
filings with the SEC, including those described in the Risk Factors and
Cautionary Statements sections of the Company's Annual Report on Form
10-K for the fiscal year ended December 29, 2012 and Quarterly Report on
Form 10-Q for the fiscal quarter ended September 28, 2013. The Company
does not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.
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