St. Jude Medical Inc.
) recently announced the first patient implants of its Portico
Re-sheathable Transcatheter Aortic Valve System, marking the start
of the PORTICO clinical trial. However, since the announcement,
shares of this global medical device company have dropped
marginally by 0.05% to close at $64.18 on the last closing date.
The trial is being conducted to evaluate the safety and performance
of the Portico transcatheter heart valve in patients with severe
aortic stenosis - the narrowing of the aortic valve that obstructs
blood flow from the heart.
Portico Transcatheter Aortic Valve System
Designed to treat patients who are at an extreme surgical risk for
open-heart valve replacement surgery, STJ's Portico Transcatheter
Aortic Valve System is the first aortic heart valve that can be
repositioned until it is fully deployed.
During a transcatheter aortic valve replacement (TAVR) procedure, a
Portico heart valve is delivered to the heart by means of a
catheter. It allows physicians to fully resheath (the process of
bringing the valve back into the delivery catheter) and accurately
reposition the Portico valve at the implant site prior to valve
deployment. Thus, the valve helps to achieve precise placement and
simplifies the implantation procedure which goes on to reduce
procedural risk for the patient.
The Portico valve is positioned in the patient's heart as it
continues to beat, removing the need for cardiopulmonary bypass,
where a machine takes over a patient's heart and lung function.
The 23 mm Portico transcatheter aortic heart valve and transfemoral
delivery system received the CE Mark in 2012 and the 25 mm Portico
valve received the same in 2013. The product is currently
restricted to investigational use in the U.S.
The PORTICO Trial
The PORTICO Trial, a multi-center, randomized and controlled
clinical trial, is being conducted under an Investigational Device
Exemption (IDE) from the U.S. Food and Drug Administration (FDA).
The trial is evaluating the safety and effectiveness of the Portico
Transcatheter Aortic Valve System in patients with high or extreme
surgical risk for open-heart surgery.
The trial will enroll patients at up to 40 U.S. sites who will
undergo the implantation based on the most suitable access method,
which includes transfemoral (valve delivered through the artery in
the leg), transapical (via the left ventricle of the heart), direct
aortic (through the ascending aorta), or subclavian (through an
artery located below the collar bone).
All trial participants will undergo a TAVR procedure receiving
either a Portico valve or another commercially available TAVR valve
in the U.S. They will be assessed by a heart team consisting of a
cardiac surgeon and an interventional cardiologist.
STJ plans to use the data collected from the trial to support FDA
approval of the Portico System. The trial will also collect
information on participants who previously had a valve replacement
surgery and are now undergoing a Portico valve placement inside an
existing artificial valve without removing it.
STJ currently carries a Zacks Rank #3 (Hold). Some better-ranked
medical product stocks include
Eagle Pharmaceuticals Inc.
Mead Johnson Nutrition Company
). All these stocks retain a Zacks Rank #2 (Buy).
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