The US Food and Drug Administration (FDA) has approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV), a minimally invasive therapy designed to treat patients with the common birth defect of congenital heart disease (CHD).
The Harmony TPV is made to treat a congenital heart defect of the right ventricle (RV), one of the four chambers of the heart, which makes it challenging for blood to travel from the heart to the lungs.
Designated as a Breakthrough Therapy under FDA’s Breakthrough Device Designation (BDD) programme, the Harmony TPV can be placed inside the native anatomy of a patient in a catheter-based procedure.
Medtronic structural heart and aortic business president Nina Goodheart said: “The availability of the Harmony TPV will allow a broader range of congenital heart disease patients access to transcatheter technology.
“Harmony TPV’s novel attributes make it the only non-surgical solution designed to adapt to a wide variety of anatomies for this specific patient population living with congenital heart disease.”
The FDA approval is based on data from the Harmony TPV clinical study, which demonstrated excellent safety (freedom from mortality) and effectiveness (acceptable hemodynamic function) at 30 days and six months, respectively.
The study also showed that patients treated with the Harmony TPV had no significant reinterventions, reoperations or endocarditis at six months.
The device is qualified as a proof-of-concept product for the Harmonization by Doing (HBD) for Children programme, a collaboration between stakeholders of academia, industry and regulatory agencies in Japan and the US to develop paediatric devices.
This partnership intends to eradicate the lag in developing medical devices for paediatric use, as compared to medical devices for adults, in both countries.
Currently, the Harmony TPV device is available for use in the US but is limited to investigational use only outside the country.
Last week, Medtronic received the CE Mark for its SenSight directional lead system for deep brain stimulation (DBS) therapy to treat symptoms linked to movement disorders and epilepsy.