|View printer-friendly version|
|St. Jude Medical Announces European Approval of the Portico Transcatheter Aortic Heart Valve|
23 mm Portico(TM) Transcatheter Aortic Heart Valve - Image courtesy of
The Portico device is the only approved transcatheter valve that can be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before it is released from the delivery system. The valve was designed in collaboration with leading physicians to address limitations of current-generation devices by improving control and accuracy in positioning and placement of the valve, minimizing paravalvular leak (a common complication with first-generation transcatheter valves) and potentially reducing the need for the implantation of a permanent pacemaker after the procedure.
“The ability to completely resheath, reposition or retrieve the Portico
valve is an important improvement over previous-generation transcatheter
valves,” said Dr. Ganesh Manoharan of
Featuring leaflets made of bovine pericardial tissue attached to a self-expanding stent, the Portico valve was designed to help increase physician control and placement accuracy during deployment of the valve.
“The European approval of the Portico transcatheter valve signals the
imminent availability of a next-generation treatment option that can
help improve quality of life for patients with diseased or damaged
aortic heart valves,” said
Dr. Manoharan recently presented first-in-human (FIH) 12-month data
demonstrating the safety and efficacy of the Portico transcatheter heart
valve at the 24th annual Transcatheter Cardiovascular
Therapeutics (TCT) scientific symposium, sponsored by the
For additional information about the Portico valve visit SJMPortico.com.
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