St. Jude Medical Gains CE Mark for 27mm & 29mm Portico TAVR Valves

St. Jude Medical, Inc. has gained CE Mark approval for the 27mm and 29mm Portico™ Transcatheter Aortic Valve Replacement System, expanding the patient group for whom TAVR with this device is now an option.

Background

It’s almost three years since St. Jude got its first CE mark for Portico as we reported at the time here. The newly announced approval now offers physicians an expanded range of fully repositionable, retrievable TAVR valve sizes, accommodating patients’ native anatomy with diameters ranging from 19 to 27 mm.

Aortic stenosis is one of the most common forms of cardiovascular disease in the world, and develops as the aortic heart valve becomes calcified, narrowing the valve and preventing a complete opening. Over time, aortic stenosis disrupts the blood flow from the heart, which causes the heart to pump harder and results in weakening. TAVR procedures provide physicians an additional treatment option for patients with severe aortic stenosis who are considered high risk for open heart surgery.

During a transfemoral implant procedure, the Portico valve is delivered by catheter through the femoral artery in the leg and is positioned while the patient’s heart continues to beat. Use of the Portico valve alleviates the use of cardiopulmonary bypass, which involves a machine taking over a patient’s heart and lung function during surgery and can cause added strain on an already frail heart.

Physician comments

“Aortic stenosis is a serious, potentially life-threatening condition for patients who are unable to receive a traditional open-heart valve transplant,” said Dr. Helge Mollmann, the cardiology head of Transcatheter Valve Therapies at Kerckhoff Heart Center Bad Nauheim, Germany. “Transcatheter aortic valve replacement 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.”

Company comments

“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,” said Eric Fain, M.D., group president at St. Jude Medical. “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.”

Source: Business Wire

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