Europe OKs Expanded Use for St. Jude’s Portico Device

St. Paul, Minn.-based St. Jude Medical Inc. has earned an expanded CE mark for its 25 mm Portico transcatheter aortic heart valve implantation system. The approval expands the number of patients who can be treated using the Portico heart valve during transcatheter aortic valve replacement (TAVR) procedures. TAVR is an option for patients with symptomatic severe aortic stenosis (a narrowing of the aortic heart valve that obstructs blood flow from the heart). These patients are considered high-risk for conventional open-heart valve replacement surgery.

“The addition of the 25 millimeter Portico valve broadens the patient population that can now be treated with this family of valves,” said Gerhard Schuler, M.D., head of the department of internal medicine/cardiology at the University of Leipzig in Leipzig Germany.

“The fact that the Portico valve is repositionable prior to valve deployment helps ensure accurate placement, potentially improving patient outcomes,” said Prof. Axel Linke, M.D., an investigator in the Portico Transfemoral CE Mark Trial (Portico TF CE Trial), also from the University of Leipzig.

The Portico valve is made of bovine pericardial tissue attached to a self-expanding stent frame, can reportedly be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site, or retrieved before being released from the delivery system.

“The Portico valve is an important part of our growing portfolio of products that treat valvular disease and heart failure. The approval of this 25 millimeter valve size will allow us to expand our footprint in the global TAVR market and provide a promising solution for patients with severe aortic stenosis,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.

According to St. Jude, the 25 mm Portico valve supports a patient’s native annulus (a ring-shaped supporting structure in the heart) with diameters ranging from 21 to 23 mm. With the addition of the 25 mm valve, the Portico platform can now treat patients with an annulus ranging from 19 to 23 mm. In 2014, St. Jude Medical expects to add two additional valve sizes to the Portico line, which will expand the eligible range of patients to those with annulus sizes ranging from 19 to 27 mm.

During an implant procedure, the Portico valve is delivered through a catheter after a small incision is made to the femoral artery in the leg. Positioned while the patient’s heart continues to beat, use of the Portico valve alleviates the use cardiopulmonary bypass, which involves a machine taking over a patients’ heart and lung function during surgery.

Aortic stenosis is the most prevalent form of cardiovascular disease in developed nations after hypertension and coronary artery disease. Considered a potentially life-threatening condition, the aortic heart valve becomes calcified and does not open properly. Roughly 25 percent of people 65 and older, have aortic valve thickening and 3 percent age 75 and older have severe stenosis.

The Portico 23 mm and 25 mm transcatheter aortic heart valves continue to be evaluated in a non-randomized, multi-center study, the Portico TF CE Trial. Data from this study was recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. Results highlighted the 23 and 25 mm Portico valves’ hemodynamic performance (the ability to maximize blood flow) and improvement in the severity of patients’ heart failure symptoms as measured by the New York Heart Association (NYHA) Functional Classification System. The 23 mm Portico transcatheter aortic heart valve received CE Mark in November 2012. However, the valve and transfemoral delivery system are not approved for use in the United States.