EU regulators OK Medtronic CoreValve aortic valve replacement

Medtronic Inc. (NYSE:MDT) said Thursday that European regulators have approved an updated version of valve replacement technology to treat patients suffering from severe aortic stenosis.

The company based in Fridley, Minnesota, said the CE Mark will allow doctors to use a new way of implanting CoreValve in countries throughout the European Union.

Last year, Medtronic acquired CoreValve Inc. for $700 million. The firm, based in Irvine, California, developed a catheter-based system to replace diseased aortic valves without open heart surgery or surgical removal of the native valves.

Earlier this year, Medtronic said a 126-patient study in Canada and Europe showed that 73 percent of patients saw their heart-failure symptoms “improve substantially” through the CoreValve technology.

Medtronic originally received the CE Mark for CoreValve in 2007. While doctors typically insert a catheter through the femoral artery in the leg, Medtronic said the latest CE Mark allows surgeons to implant the device via the less invasive subclavian artery located beneath the collar bone. The technique significantly opens Medtronic’s potential patient pool to people with femoral arteries either too narrow or diseased for the normal procedure.

“The subclavian approach will give physicians expanded access to care for a significant underserved subset of patients for whom femoral delivery is not possible or desirable,” Dr. Neil Moat, consultant cardiac surgeon at The Royal Brompton Hospital in London, said in a statement.

“Given the sheer number of patients with severe aortic stenosis along with the aging population, the need for new approaches to valve replacement continues to increase,” Moat said.