St Jude Medical has announced the first patient implants in the US Investigational Device Exemption (IDE) Portico trial, evaluating its re-sheathable transcatheter aortic valve system in patients who are considered to have a high or an extreme surgical risk for open-heart surgery.
Initial implants in the Portico trial have been performed on the same day at the two centres in the US.
As part of the trial, Dr Gregory Fontana and Dr Raj Makkar serve as co-principal investigators.
Dr Fontana said that the valve and delivery system were designed to provide safer treatment for heart failure symptoms in patients with stenotic valves.
Dr Makkar said that the ability to fully resheath and precisely reposition the Portico valve at the implant site prior to valve deployment helps achieve accurate placement, which may simplify the implant procedure and help minimise procedural risk for the patient.
A self-expanding Portico heart valve is delivered through a catheter using either a transfemoral or an alternative access approach during transcatheter aortic valve replacement (TAVR) procedures to gain access to the heart.
The Portico trial is a randomised, controlled clinical trial evaluating safety and effectiveness of the Portico transcatheter aortic valve system in reducing the risk of death and disabling stroke in patients with high or extreme surgical risk for open-heart valve replacement surgery.
The IDE study, which will enrol patients at up to 40 US sites, is evaluating the Portico valve and delivery system in patients with symptomatic severe aortic stenosis. These patients will be randomised based on the appropriate access method, including transfemoral, transapical, direct aortic, or subclavian.
All patients will undergo a TAVR procedure receiving either a Portico valve or another commercially available TAVR valve in the US. Data collected will be used to support the US Food and Drug Administration's (FDA) approval of the Portico system.
The Portico trial will also gather information in the form of a registry on patients with a degenerated aortic surgical bioprosthetic valve.
Based on the company's Trifecta valve platform, the Portico heart valve can be completely resheathed, repositioned at the implant site, or retrieved before being released from the delivery system.
The Portico transcatheter aortic heart valve system is limited to investigational use in the US.
Image: St Jude Medical's Porticotranscatheter aortic heart valve. Photo: courtesy of St Jude Medical, Inc.