The European Union has given CE mark approval to St Jude Medical's Portico Transcatheter aortic heart valve, designed to treat patients with severe aortic stenosis who are inoperable or high-risk for open-heart surgery.
Implanted percutaneously through a small incision in the femoral artery, the 23mm aortic valve features a transfemoral delivery system and leaflets made of bovine pericardial tissue to help increase physician control and placement accuracy during deployment of the valve.
The device can be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before it is released from the delivery system, according to the company.
Royal Victoria Hospital spokesperson Dr Ganesh Manoharan said this resheathing ability is an important improvement over previous-generation transcatheter valves.
"This is particularly helpful in ensuring accurate placement of the valve and minimising complications for this high risk population," Manoharan said.
St Jude Medical cardiovascular and ablation technologies division president Frank Callaghan said with the European approval of the Portico valve, patients with diseased or damaged aortic heart valves have received a new treatment option that can help improve quality of life.
"It also represents a key milestone for St Jude Medical's transcatheter heart valve program, and exemplifies our focus on developing technologies that advance the practice of medicine," Callaghan said.
Several studies conducted on the device including first-in-human 12-month trial's data has shown no vascular complications, major strokes or deaths among study patients and no new pacemakers required.
To further support CE mark approval, the company is also planning to begin a European study of the 25mm valve before the end of the year.
Image: The 23 mm Portico Transcatheter aortic heart valve treatspatients with severe aortic stenosis who are at intermediate risk of needing open-heart surgery. Photo: Courtesy of St Jude Medical.