St. Jude Medical's PORTICO Trial Under Way - Analyst Blog

St. Jude Medical Inc. STJ 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.

Zacks Rank

STJ currently carries a Zacks Rank #3 (Hold). Some better-ranked medical product stocks include Cardica Inc. CRDC, Eagle Pharmaceuticals Inc. EGRX and Mead Johnson Nutrition Company MJN. All these stocks retain a Zacks Rank #2 (Buy).