US-Irish firm Medtronic (NYSE: MDT) has announced that its Harmony Transcatheter Pulmonary Valve (TPV) System has received CE marking, a significant step in expanding its market reach for this minimally invasive alternative to open-heart surgery. The Harmony TPV System is designed for patients with congenital heart disease, specifically those with native or surgically repaired right ventricular outflow tract (RVOT) and severe pulmonary valve regurgitation (PR). This endorsement follows the FDA’s approval of the product in 2021.
Product Overview and Clinical Trials
The Harmony TPV System has been implanted in over 2,200 patients, demonstrating its ease of implantation, conformability to the anatomy, and strong clinical and hemodynamic outcomes. Clinical trials have shown that the system provides significant benefits for congenital heart disease patients, with positive results observed up to three years post-implantation.
Significance of the CE Mark
The CE marking for the Harmony TPV System is a testament to Medtronic’s commitment to providing innovative and minimally invasive solutions for complex cardiac conditions. This approval will enable the company to offer this advanced treatment option to a broader patient population in Europe, enhancing the standard of care for those with congenital heart disease.-Fineline Info & Tech
