St. Jude Medical has received European CE Mark approval for its 23 mm Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System. Transcatheter aortic valve implantation (TAVI) is used in patients with severe aortic stenosis who are at very high surgical risk or with contraindications to surgical aortic valve replacement. The Portico is the first transcatheter aortic valve implantation system with a fully resheathable valve, allowing for easy repositioning and fine-tuning of valve placement at the implant site. It can even be retrieved at all times until the moment it is fully deployed.
The Portico valve consists of leaflets made of bovine pericardial tissue attached to a self-expanding stent. It is implanted by threading a catheter through a small incision in the femoral artery to deliver and position the valve in the heart without the need for cardiopulmonary bypass. The new design enables optimal positioning and reduces chances of complications. Conduction system interference is minimized by placing the valve low within the stent frame which allows for sealing without the valve extending deep into the left ventricular outflow tract. Furthermore, the large cells in the annulus section of the stent are designed to reduce the risk of paravalvular leak because of less metal that can rest against calcific nodules in combination with more tissue, allowing the tissue to conform around the nodules.
12-month follow-up data from the first human trials, presented recently at the Transcatheter Cardiovascular Therapeutics scientific symposium, showed no vascular complications, major strokes or deaths among study patients and no new pacemakers required. Clinical improvements, including valve function, were sustained up to 12 months. St. Jude Medical also intends to begin a European study of a larger 25 mm valve to support CE Mark approval.
Product page: Portico Transcatheter Aortic Valve Implantation System…