St Jude Medical gets CE Mark approval for 25mm Portico Transcatheter Aortic Heart Valve
Decision expands number of patients who can be treated using the device during transcatheter aortic valve replacement procedures
St Jude Medical has received European CE Mark approval for its 25 mm Portico Transcatheter Aortic Heart Valve Implantation System.
The approval expands the number of patients who can be treated using the device 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 approval of this 25mm 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
“The addition of the 25mm Portico valve broadens the patient population that can now be treated with this family of valves,” said Professor 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,” added Professor Axel Linke, an investigator in the Portico Transfemoral CE Mark Trial, also from the University of Leipzig.
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 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 25mm 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.
The 25mm Portico valve supports a patient’s native annulus - a ring-shaped supporting structure in the heart - with diameters ranging from 21 to 23mm. With the addition of the 25mm valve, the Portico platform can now treat patients with an annulus ranging from 19 to 23mm.
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 27mm.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.
The fact that the Portico valve is repositionable prior to valve deployment helps ensure accurate placement, potentially improving patient outcomes
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% of people 65 and older, have aortic valve thickening and 3% age 75 and older have severe stenosis.
The Portico 23mm and 25mm transcatheter aortic heart valves continue to be evaluated in a non-randomised, 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. The results highlighted the 23 and 25mm Portico valves’ exceptional hemodynamic performance - the ability to maximise 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 23mm Portico Transcatheter Aortic Heart Valve received CE Mark in November 2012. The Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System are not approved for use in the United States.
