Medtronic (NYSE: MDT) has announced that its Harmony transcatheter pulmonary valve (TPV) system has secured CE mark approval. According to Children’s HeartLink, a nonprofit from Minneapolis, approximately 1.3 million children worldwide are born annually with congenital heart defects. The Harmony system offers these congenital heart disease patients, who have a native or surgically corrected right ventricular outflow tract (RVOT), a minimally invasive method as an alternative to open-heart surgery.
Initially approved by the FDA in March 2021, the Harmony system faced a Class I recall in April 2022 due to a potential issue with the capsule delivery catheter bond integrity. Medtronic reintroduced Harmony in the U.S. by February 2023, showcasing positive two-year outcomes.
With over 2,200 recipients of the Harmony valve, the recent European Union approval paves the way for broader accessibility. “The enhanced availability of the Harmony TPV system provides a vital solution, ensuring more patients benefit from pioneering transcatheter technology and potentially reducing surgical interventions,” stated Nina Goodheart, SVP and president of Medtronic’s Structural Heart & Aortic division.
Ms. Goodheart added, “This important achievement highlights our steadfast dedication to offering minimally invasive treatment options that are both safely and effectively delivered worldwide.”
Medtronic notes that up to 80% of those with congenital heart disease requiring an RVOT repair at birth will later need a pulmonary valve replacement—traditionally involving additional open-heart procedures.
Dr. Peter Ewert, a professor and director at the German Heart Center in Munich, expressed, “Obtaining CE Mark for the Harmony TPV system boosts the availability of minimally invasive solutions to physicians treating this sensitive group, aiding in optimizing patient outcomes.”
Dr. Ewert concluded, “Healthcare professionals across Europe have sought these solutions, and this achievement may be transformative for patients eager to reduce surgeries and lessen healthcare disruptions in their lives.”