ST. PAUL,
Minn.–(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.
Posted by Sean Fenske, Editor-in-Chief, MDT
