St. Jude Medical Announces First Implant of Portico Transcatheter Heart Valve
June 07 2011 - 8:30AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the first human implant of its Portico™
transcatheter aortic heart valve. The procedure was performed by
Dr. John Webb, director of cardiac catheterization and
interventional cardiology at St. Paul's Hospital in Vancouver,
British Columbia.
“The first human implant of the Portico transcatheter valve is a
significant milestone for our transcatheter aortic valve
replacement program and was built off of our 30-year legacy in
surgical heart valves,” said Frank J. Callaghan, president of the
St. Jude Medical Cardiovascular Division. “The valve is designed to
resolve several key limitations associated with the first
generation of transcatheter valves, and it demonstrated some of
these benefits as it was recaptured and repositioned during its
first implant procedure.”
The valve, which is 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) and retrieved before it is released
from the delivery system, allowing physicians to reposition the
valve at the implant site. No transcatheter valve currently on the
market has the ability to be re-sheathed, repositioned, or
retrieved.
The St. Jude Medical 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. Two delivery methods will be
available for the Portico valve, transfemoral (delivered via the
femoral artery) and transapical (delivered via a small incision in
the apex of the left ventricle).
Commenting on the first implant, Dr. Gregory Fontana, professor
and vice chairman, Department of Surgery at the Cedars-Sinai Heart
Institute in Los Angeles, Calif., said, “Many of the shortcomings
of first generation devices have been addressed with the next
generation St. Jude Medical Portico transcatheter valve.”
In February 2010, St. Jude Medical announced that Dr. Fontana,
and Dr. Raj Makkar, director of the Interventional Cardiology and
Cardiac Catheterization Laboratory at the Cedars-Sinai Heart
Institute, will be the principal investigators in the company's
transcatheter aortic valve implantation (TAVI) clinical trial. The
study will evaluate the safety and efficacy of the St. Jude Medical
transcatheter aortic valve for patients who experience severe
aortic stenosis and who may be at an elevated risk for open-heart
surgery.
“The St. Jude Medical transcatheter valve is a promising new
technology that is likely to offer increased functionality for
transfemoral and transapical implantation,” said Dr. Makkar. “We
are looking forward to offering an advanced, less-invasive
treatment for patients at high risk for surgery.”
The European clinical trial of the St. Jude Medical
transcatheter aortic valve is expected to start in late 2011.
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 April 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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