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September 20, 2015

St Jude Medical gets CE Mark for new Portico TAVR valves to treat aortic stenosis

US-based medical device company St Jude Medical has received European CE Mark approval for the 27mm and 29mm Portico transcatheter aortic valve replacement (TAVR) system.

US-based medical device company St Jude Medical has received European CE Mark approval for the 27mm and 29mm Portico transcatheter aortic valve replacement (TAVR) system.

The system is designed to treat patients with aortic stenosis, the most common form of cardiovascular disease.

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

"By offering a complete portfolio of Portico valve sizing options, St Jude Medical has further helped broaden the patient population that can be treated with this family of valves."

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

Aortic stenosis is developed as the aortic heart valve becomes calcified, narrowing the valve and preventing a complete opening.

The company’s TAVR procedures offer physicians an additional treatment option for patients with severe aortic stenosis who are considered high risk for open heart surgery.

Kerckhoff Heart Center Bad Nauheim Transcatheter Valve Therapies cardiology head Dr Helge Mollmann said: "Aortic stenosis is a serious, potentially life-threatening condition for patients who are unable to receive a traditional open-heart valve transplant.

"Transcatheter aortic valve replacement has revolutionised how we treat these patients, and by offering a complete portfolio of Portico valve sizing options, St Jude Medical has further helped broaden the patient population that can be treated with this family of valves."

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

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

The Portico valve is currently being evaluated in a US clinical trial through an investigational device exemption (IDE) by US Food and Drug Administration.

Launched in May 2014, the Portico IDE trial is designed to support US approval of the Portico system.

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