St. Jude Medical's 27-mm and 29-mm Portico TAVR Valves Gain CE Mark Approval

September 18, 2015—St. Jude Medical, Inc. announced the European CE Mark approval for the 27-mm and 29-mm Portico transcatheter aortic valve replacement (TAVR) system. With the previously CE Mark-approved 23-mm and 25-mm Portico valves, St. Jude Medical’s Portico portfolio offers physicians an expanded range of fully repositionable, retrievable TAVR valve sizes. The Portico valve accommodates a patient’s native anatomy with diameters ranging from 19 to 27 mm. The Portico TAVR system is designed for transfemoral delivery.

In the company’s press release, Helge Mollmann, MD, commented, “Aortic stenosis is a serious, potentially life-threatening condition for patients who are unable to receive a traditional open-heart valve transplant. TAVR has revolutionized 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.” Dr. Mollmann is the Cardiology Head of Transcatheter Valve Therapies at Kerckhoff Heart Center in Bad Nauheim, Germany.

In the United States, the Portico valve is being evaluated in the PORTICO IDE clinical trial through a US Food and Drug Administration (FDA) investigational device exemption. The trial, which was launched in May 2014, is designed to support FDA approval of the Portico system.