Medtronic’s Harmony TPVR system gains CE mark approval
![Transcatheter pulmonary valve replacement (TPVR) with Medtronic’s self-expanding Harmony valve is both safe and effective after more than a year, according to new real-world data published in the Journal of the American College of Cardiology.[1]](/sites/default/files/styles/top_stories/public/2024-04/screen_shot_2024-04-04_at_3.49.33_pm_0.png.webp?itok=5SuKgFg7)
Medtronic has received CE mark approval for its self-expanding Harmony transcatheter pulmonary valve replacement (TPVR) system, meaning the device can now be sold and marketed throughout the European Union.
The Harmony TPVR system was previously approved by the U.S. Food and Drug Administration (FDA) in 2021 to treat a leaky native or surgically repaired right ventricular outflow tract (RVOT) in pediatric and adult patients with severe pulmonary regurgitation (PR). Medtronic did initiate a voluntary recall in 2022 due to durability issues, but relaunched the device less than one year later.
“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,” Nina Goodheart, senior vice president and president of Medtronic’s structural heart and aortic business, said in a statement. “This significant milestone underscores our unwavering commitment to delivering minimally invasive treatment options with excellent safety and effectiveness to patients and physicians worldwide.”
“Receiving a CE mark for the Harmony TPV system helps advance options for minimally invasive solutions for physicians to treat this vulnerable patient population and optimize their outcomes,” added Peter Ewert, MD, PhD, 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.”
According to a recent analysis published in the Journal of the American College of Cardiology, the self-expanding TPVR system is both safe and effective after more than a full year. The study included data from 243 real-world patients treated in the United States through April 2022. The median patient age was 31 years old, and the youngest patient was eight years old at the time of the procedure.
Freedom from the composite clinical outcome—hemodynamic dysfunction and/or RVOT reintervention—was seen in 99% of patients after one year and 96% after two years.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.