St. Jude Medical has reported the first patient implants in the US Investigational Device Exemption (IDE) trial (PORTICO trial) evaluating its Portico re-sheathable transcatheter aortic valve system, the first aortic heart valve that is repositionable until fully deployed.
First implants in the PORTICO trial have been performed on the same day on opposite coasts of the US.
The operating team that performed the first implants in the PORTICO trial at the Cedars-Sinai Heart Institute in Los Angeles includes Dr Raj Makkar, director of Interventional Cardiology, and Thoracic Surgery Residency Program program director and cardiothoracic surgeon Dr Wen Cheng.
The other operating team that performed the first implants in the PORTICO trial includes department of cardiothoracic surgery chairman and cardiac surgeon Dr Gregory Fontana and Lenox Hill Hospital in New York City interventional cardiologist Dr Carlos Ruiz.
Dr Fontana and Dr Makkar serve as co-principal investigators for the PORTICO trial.
Dr Fontana said that the valve and delivery system were designed to more safely treat 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 minimize 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 in order to gain access to the heart.
The heart valve is positioned in the patient’s heart as it continues to beat, alleviating the need for cardiopulmonary bypass, where a machine takes over a patient’s heart and lung function.
PORTICO is a multi-center, randomized, controlled clinical trial evaluating the 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 is evaluating the Portico valve and delivery system in patients with symptomatic severe aortic stenosis.
The study will enroll patients at up to 40 US sites and these patients will be randomized based on the appropriate access method, including transfemoral, transapical, direct aortic, or subclavian.
All patients will undergo a transcatheter aortic valve replacement (TAVR) procedure receiving either a Portico valve or another commercially available TAVR valve in the US. Data that are collected will be used to support the US Food and Drug Administration’ (FDA) approval of the Portico system.
The PORTICO trial will also collect information in the form of a registry on patients with a degenerated aortic surgical bioprosthetic valve. These are patients in the trial who previously had valve replacement surgery and now are having a Portico valve placed inside an existing artificial valve without removing it.
The Portico transcatheter aortic valve has been built on the company’s Trifecta valve platform. The heart valve can be completely resheathed, repositioned at the implant site, or retrieved before being released from the delivery system.
St. Jude Medical has designed the Portico valve to maintain hemodynamics similar to that of a natural valve, while also addressing issues from early generations of transcatheter valves, such as paravalvular leak and the need for a permanent pacemaker as a result of the implant.
In 2012, St. Jude Medical obtained a CE Mark approval for the 23mm Portico transcatheter aortic heart valve and transfemoral delivery system. In 2013, the company received a CE Mark approval for its 25mm Portico valve.
Currently, clinical trials are in progress for CE Mark approval for additional valve sizes and delivery approaches. The Portico transcatheter aortic heart valve system is limited to investigational use in the US.