Medtronic gains CE mark for “world’s first” heart valve replacement system

Medtronic has been awarded with a CE mark of approval for its Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System.

The company’s pioneering therapies enable the treatment of congenital patients who have structural heart disease and require replacement pulmonary heart valves.

Most patients with the condition are faced with numerous open heart surgery procedures during their lives to maintain blood flow between their right ventricle and pulmonary artery. However Medtronic’s delivery systems offer an alternative method significantly reducing the need for surgery.

Dr Oern Stuge, senior vice president and president of cardiac surgery at Medtronic, comments: “While the population that will benefit from this new technology is relatively small, Medtronic is committed to patient-centred lifetime management of congenital heart disease.

“By providing less invasive options for physicians and therefore eliminating even one open heart procedure for a patient, we improve that patient’s quality of life immeasurably.”

According to the firm, transcatheter valve technology helps physicians treat patients without resorting to risky and “uncomfortable” surgery involving opening their chest.

Medtronic develops a number of technologies to assist with cardiac surgery and cardiac rhythm disease management and claims that a patient’s life is “saved or improved” by one of its products or therapies every five seconds.