St. Jude Medical Announces First Implant in European Clinical Trial Studying Portico Transcatheter Aortic Heart Valve
December 13 2011 - 10:29AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the first implant of its Portico™
transcatheter aortic valve implant (TAVI) in a European clinical
trial to support CE Mark approval. The trial will study the safety
and effectiveness of the Portico heart valve for patients with
severe symptomatic aortic stenosis (narrowing of the aortic heart
valve), who are at high risk for conventional open-heart valve
replacement therapy.
The trial is a non-randomized study that will take place at five
European centers, and will enroll a minimum of 30 patients who will
be followed for one year. The primary endpoint is 30-day all-cause
mortality, with secondary safety and effectiveness endpoints. Dr.
Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K. is the
principal investigator for the trial.
“Based on our experience implanting the valve during our
feasibility study, and the positive patient outcomes we have seen
in those patients, we are looking forward to studying the use of
this next-generation technology with additional patients,” said Dr.
Manoharan, who implanted the first patient in the trial.
The Portico valve, with leaflets made of bovine pericardial
tissue, is designed to increase physicians' control and placement
accuracy during valve deployment. The Portico transcatheter heart
valve can be completely resheathed (the process of bringing the
valve back into the delivery catheter) allowing physicians to
reposition the valve at the implant site or retrieve the valve,
before it is released from the delivery system, an advancement over
current-generation transcatheter valves.
The Portico transcatheter heart valve was designed for the
estimated 400,000 patients with severe aortic stenosis who are
considered to be high risk or inoperable for conventional
open-heart valve replacement therapy. While the trial will study
the 23 mm Portico valve and transfemoral delivery system, both
transfemoral (delivered via the femoral artery) and transapical
(delivered via a small incision in the apex of the left ventricle)
approaches are ultimately expected to be possible with the Portico
valve portfolio.
“With the initiation of our European pivotal trial, we continue
to make strides toward the commercialization of our Portico
transcatheter heart valve,” said Frank J. Callaghan, president of
the St. Jude Medical Cardiovascular Division. “We remain on track
to begin a limited launch of this product in Europe before the end
of 2012.”
About St. Jude Medical
St. Jude Medical develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The
company is dedicated to advancing the practice of medicine by
reducing risk wherever possible and contributing to successful
outcomes for every patient. St. Jude Medical is headquartered in
St. Paul, Minn. and has four major focus areas that include:
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com.
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 1, 2011 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 2, 2011. 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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