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St. Jude Medical receives CE mark approval for new diameters of Portico TAVR valves

Medical device firm St. Jude Medical has received CE mark approval for the 27mm and 29mm Portico transcatheter aortic valve replacement (TAVR) system.

St Jude

Earlier, the firm obtained approval for the 23mm and 25mm Portico valves, providing physicians with an expanded range of fully repositionable and retrievable TAVR valve sizes.

The Portico valve is said to accommodate a patient’s native anatomy with diameters ranging from 19mm to 29mm.

St. Jude Medical group president Dr Eric Fain said: "Transcatheter aortic valve replacement is a complex procedure, and feedback from physicians worldwide has continued to press upon us the fact that offering a system that provides physicians more control and a simplified procedure is important.

"In developing our Portico valve, we took such feedback into account, designing a full portfolio of sizing to ensure physicians could comfortably rely on one device family for a range of patients."

The firm developed the Portico system to simplify TAVR procedures for physicians and it showed low rates of permanent pacemaker utilizations post valve implant as a result of heart block.

It has been designed to minimize the risk of paravalvular leak, a leakage of blood caused by a space between the heart tissue and a replacement valve.

In the US, the Portico valve is currently being assessed in a clinical trial through an investigational device exemption (IDE) by the FDA.

In July this year, St. Jude Medical signed an agreement to acquire US-based Thoratec, for around $3.4bn, which is involved in developing mechanical circulatory support (MCS) technology to treat advanced heart failure (HF), including ventricular assist devices (VADs) that are used for both chronic and acute patient support.


Image: St. Jude Medical’s global headquarters. Photo: courtesy of St. Jude Medical, Inc.