St Jude Medical has received CE mark approval for its Portico Transcatheter aortic heart valve which is designed to treat patients with severe aortic stenosis who are at intermediate risk for undergoing open-heart surgery.
The 23 mm aortic valve, which is implanted percutaneously through a small incision in the femoral artery, features a transfemoral delivery system and leaflets made of bovine pericardial tissue .
In addition, 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.
Royal Victoria Hospital spokesperson Ganesh Manoharan said the ability to completely resheath, reposition or retrieve the Portico valve is an important improvement over previous-generation transcatheter valves.
"This is particularly helpful in ensuring accurate placement of the valve and minimizing complications for this high risk population," Manoharan added.
St. Jude Medical cardiovascular and ablation technologies division president Frank Callaghan said with the European approval of Portico valve, patients have received a new treatment option that can help improve quality of life for patients with diseased or damaged aortic heart valves.
"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 added.
To further support CE mark approval, the company is also planning to begin a European study of the 25 mm valve before the end of the year.