ST. PAUL, Minn.–(BUSINESS
WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced the feasibility study results for the companys Portico™ Transcatheter
Aortic Heart Valve, presented at the 23rd annual Transcatheter Cardiovascular
Therapeutics (TCT) scientific symposium.
The results presented today by Dr. Ganesh Manoharan were
part of a 10 patient feasibility study conducted at the Royal
in Belfast, Northern Ireland. The objectives of
the study were to determine the technical feasibility, safety and device
deployment characteristics of the 23 mm Portico Transcatheter Aortic Heart
Valve and transfemoral delivery system.
At 30 days, study results showed no device or
procedure-related adverse events or death. Significantly, the results also
demonstrated that a majority of patients had trivial or no paravalvular leak
after 30 days. In heart valve replacement procedures, paravalvular leak
typically results from a small opening around the outside of the valve.
“Based on our experience implanting the valve and the
positive patient outcomes we have seen in these 10 patients, the Portico
transcatheter valve technology looks very promising,” said Dr. Manoharan. “The
St. Jude Medical valve is proving to truly be a next-generation technology.
Having the ability to resheath and reposition the valve allowed for accurate
valve placement, which – combined with the valves open cell stent design –
likely contributed to the impressive results.”
The Portico 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) allowing physicians to reposition the valve at the implant site or
retrieve the valve, before it is released from the delivery system.
During the feasibility study, the valve was successfully
resheathed twice. No patients in the study required implantation of a
pacemaker, there were no clinical strokes, no vascular complications and no
additional valves were implanted during the same procedure.
The St. Jude Medical 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. 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).
The European clinical trial for the Portico transcatheter
aortic valve is expected to start before the end of 2011.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific
symposium of the Cardiovascular Research Foundation. Presented in
partnership with the American College of Cardiology (ACC), TCT 2011 is the worlds
leading educational meeting specializing in interventional cardiovascular
medicine and takes place November 7-11, 2011 in San Francisco. http://www.tctconference.com/.
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