Healthcare technology company Medtronic has received Conformité Européenne (CE) mark approval for its Harmony Transcatheter Pulmonary Valve (TPV) System.
This minimally invasive valve offers an alternative to open-heart surgery for patients with congenital heart disease and native or surgically repaired right ventricular outflow tract (RVOT) issues.
The Harmony TPV system has been successfully implanted in over 2,200 patients and will now be available to more patients across the European Union.
The system is designed to treat patients with RVOT anomalies and severe pulmonary valve regurgitation (PR), a condition in which blood leaks back into the heart’s right lower chamber after being pumped to the lungs.
Medtronic said that the Harmony TPV system has offered ease of implantation, better anatomical fit, and strong clinical and haemodynamic outcomes for congenital heart disease patients, with results lasting up to three years in clinical trials.
Medtronic cardiovascular portfolio structural heart and aortic business senior vice president and president Nina Goodheart said: “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.
“This significant milestone underscores our unwavering commitment to delivering minimally invasive treatment options with excellent safety and effectiveness to patients and physicians worldwide.”
The Harmony system received US Food and Drug Administration (FDA) clearance in March 2021 based on data from the Harmony TPV clinical study. The trial demonstrated safety and effectiveness for up to six months, with no significant reinterventions.
However, in March 2022, Medtronic issued a voluntary recall due to six reported cases of the bond holding the capsule at the end of the delivery catheter breaking during TPV placement.
In February 2023, Medtronic relaunched the system in the US.
The Harmony TPV system has also secured regulatory approval in Japan. The device will be commercially available across Europe later this month.
In November last year, Medtronic received the FDA approval for a new InPen app designed for use with its Smart Multiple Daily Injection (MDI) system.
