Medtronic has received CE mark for the Harmony transcatheter pulmonary valve (TPV) system, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT).
The Harmony TPV system has already been implanted in over 2,200 patients and now has access to help many more patients across the European Union, Medtronic says in a press release.
The Harmony TPV system is designed to treat patients with RVOT anomalies with severe pulmonary valve regurgitation (PR), a condition where blood leaks back into the right lower chamber of the heart after being pumped into the lungs. Harmony TPV system clinical trials demonstrate ease of implant, conformability to the anatomy, and strong clinical and hemodynamic outcomes for congenital heart disease patients up to three years, the company adds.
“The expansion of the Harmony TPV system enables a critical new solution, ensuring that more patients can have access to cutting-edge transcatheter technology and potentially lessen the need for multiple surgeries,” said Nina Goodheart, senior vice president and president of the Structural Heart & Aortic business, which is part of the Cardiovascular Portfolio at Medtronic. “This significant milestone underscores our unwavering commitment to delivering minimally invasive treatment options with excellent safety and effectiveness to patients and physicians worldwide.”
Congenital heart disease (CHD) is the most common type of birth defect in Europe, affecting an estimated 40,000 infants each year and 2.3 million adults who live with the disease. Approximately one in five patients born with CHD have structural malformations that disrupt the connection between the heart and the lungs, or the RVOT.
The current standard of care is open-heart surgery or other interventions early in life to address these malformations. For the 80% of CHD patients who require a native or surgically repaired RVOT at birth, many will need a pulmonary valve replacement later in life, which often requires another open-heart surgery.
“Receiving CE Mark for the Harmony TPV system helps advance options for minimally invasive solutions for physicians to treat this vulnerable patient population and optimise their outcomes,” said Peter Ewert, director of the Department of Congenital Heart Defects and Pediatric Cardiology at the German Heart Center in Munich, Germany. “Clinicians across Europe are in need of solutions to fill this gap, and this milestone will be a potential turning point for patients who want to avoid multiple surgeries and minimize medical disruptions in their daily lives.”
CE Mark follows US Food and Drug Administration approval of the system in 2021. Harmony TPV US mid-term (three-year) data results demonstrated superior patient outcomes with positive sustained RV remodeling, effective valve function, and a strong safety profile, all contributing to significant improvement in patient quality of life. The device is expected to be commercially available across Europe later this month.
