St. Jude Medical on Thursday announced it has received European CE Mark approval for its 25 mm Portico Transcatheter Aortic Heart Valve Implantation System. The Little Canada-based company said the approval expands the number of patients who can be treated using the Portico heart valve during transcatheter aortic valve replacement (TAVR). TAVR is an option for patients with severe aortic stenosis (a narrowing of the aortic heart valve that obstructs blood flow from the heart) who are considered high-risk for 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 Prof. Gerhard Schuler, 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, an investigator in the Portico Transfemoral CE Mark Trial (Portico TF CE Trial), also from the University of Leipzig.
The Portico system is not yet approved for sale in the United States. European approval often comes two to three years before U.S. approval.
Made of bovine pericardial tissue attached to a self-expanding stent frame, the Portico valve is the first transcatheter aortic heart valve that can be brought back into the delivery catheter and repositioned 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.
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 the Western world 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.
