Medical technology developer St Jude Medical has implanted the first patient with a 25mm Portico Transcatheter aortic heart valve using the transfemoral delivery system in its ongoing European trial.
The 25mm Portico valve, which is made of bovine pericardial tissue and attached to a self-expanding stent frame, is implanted using a catheter placed through a small incision in the femoral artery to restore normal blood flow to the heart and treat severe aortic stenosis.
The minimally invasive device can also be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before it is released from the delivery system.
The non-randomised, multi-centre study, Portico TF EU, forms part of the company’s transcatheter valve programme and its strategy to provide new options to patients with aortic valvular heart disease.
The trial, which will enrol up to 50 patients across Europe, will assess the safety and performance of the Portico 25mm heart valve in patients with severe aortic stenosis.
The company said it will use the trial data to further support CE mark approval.
In addition, the company is planning to start Portico valve’s US clinical trial, under the US Food and Drug Administration’s investigational device exemption, later in 2013.
The Portico Transcatheter aortic heart valve and transfemoral delivery system are not approved for use in the US.
Image: The 25mm Portico Transcatheter aortic heart valve restores normal blood flow to the heart for treating severe aortic stenosis. Photo: courtesy of St. Jude Medical, Inc.