St. Jude Medical Gains CE Mark for 27mm & 29mm Portico TAVR Valves to Complete a Full Portfolio of Portico Sizing Options for...
September 18 2015 - 8:00AM
Business Wire
The latest approval increases patient access to the Portico
system, a TAVR valve that provides excellent patient outcomes and
the opportunity to optimize device placement
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the European CE Mark approval for the 27mm
and 29mm Portico™ Transcatheter Aortic Valve Replacement System.
The approval follows previous approvals of the 23mm and 25mm
Portico valves, allowing St. Jude Medical to offer physicians an
expanded range of fully repositionable, retrievable TAVR valve
sizes. The Portico valve accommodates a patient’s native anatomy
with diameters ranging from 19 to 27 mm.
Aortic stenosis is one of the most common forms of
cardiovascular disease in the world, and develops as the aortic
heart valve becomes calcified, narrowing the valve and preventing a
complete opening. Over time, aortic stenosis disrupts the blood
flow from the heart, which causes the heart to pump harder and
results in weakening. TAVR procedures provide physicians an
additional treatment option for patients with severe aortic
stenosis who are considered high risk for open heart surgery.
“Aortic stenosis is a serious, potentially life-threatening
condition for patients who are unable to receive a traditional
open-heart valve transplant,” said Dr. Helge Mollmann, the
cardiology head of Transcatheter Valve Therapies at Kerckhoff Heart
Center Bad Nauheim, Germany. “Transcatheter aortic valve
replacement has revolutionized how we treat these patients, and by
offering a complete portfolio of Portico valve sizing options, St.
Jude Medical has further helped broaden the patient population that
can be treated with this family of valves.”
The Portico system was developed to simplify TAVR procedures for
physicians by improving control, ease of use and accuracy over
other commercially-available TAVR valves. The system offers the
ability for the Portico valve to be fully recaptured and
repositioned prior to full deployment and release from the delivery
system, providing physicians more options to place the valve in the
targeted location. The Portico system has also demonstrated low
rates of permanent pacemaker utilizations post valve implant as a
result of heart block and was designed to minimize the risk of
paravalvular leak (a leakage of blood caused by a space between the
heart tissue and a replacement valve).
“Transcatheter aortic valve replacement is a complex procedure,
and feedback from physicians worldwide has continued to press upon
us the fact that offering a system that provides physicians more
control and a simplified procedure is important,” said Eric Fain,
M.D., group president at St. Jude Medical. “In developing our
Portico valve, we took such feedback into account, designing a full
portfolio of sizing to ensure physicians could comfortably rely on
one device family for a range of patients.”
During a transfemoral implant procedure, the Portico valve is
delivered by catheter through the femoral artery in the leg and is
positioned while the patient’s heart continues to beat. Use of the
Portico valve alleviates the use of cardiopulmonary bypass, which
involves a machine taking over a patient’s heart and lung function
during surgery and can cause added strain on an already frail
heart.
The 23mm the 25mm Portico Transcatheter Aortic Heart Valve are
both CE Mark approved and commercially available in Europe. In the
United States, the Portico valve is currently being evaluated in a
clinical trial through an investigational device exemption (IDE) by
the U.S. Food and Drug Administration (FDA). The Portico IDE trial
originally launched in May 2014, and is designed to support U.S.
approval of the Portico system.
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.
Forward-Looking Statements
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
January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 4, 2015. 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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version on businesswire.com: http://www.businesswire.com/news/home/20150918005078/en/
St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorLaurel Hood, 651-756-2853Media
Relationslhood02@sjm.com
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