Medtronic has secured the US Food and Drug Administration (FDA) approval for its Harmony Transcatheter Pulmonary Valve (TPV) to treat patients with congenital heart disease (CHD).

Harmony TPV is a minimally invasive therapy to treat structural malformations in CHD patients called the right ventricular outflow tract (RVOT) that disrupts the connection between the heart and the lungs.

The pulmonary valve is designed to be placed inside a patient’s body during a catheter-based procedure, and has received the FDA breakthrough therapy designation.

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.”

FDA approval is based on data from Harmony TPV clinical trial

The current standard of care for RVOT in the US requires the patients to undergo an open-heart surgery or other early interventions to address the malformations.

Most of the CHD patients who undergone a native or surgically repaired RVOT at birth may require a pulmonary valve replacement later in life, involving another open-heart surgery.

Medtronic said that its Harmony TPV provides an alternative to the invasive open-heart surgery, as the valve is delivered using a catheter, from the femoral vein or in the neck and placed directly inside the heart.

The US FDA approved Harmony TPV based on clinical trial data that demonstrated superior safety at 30 days and effectiveness at six months.

According to the study data, patients treated with Harmony TPV experienced no significant reinterventions, reoperations or endocarditis at six months, said the company.

Harmony TPV clinical study investigator Matthew J Gillespie said: “The typical congenital heart disease patient will face a multitude of open-heart surgeries over their lifetime, to continually address issues with their pulmonary valve.

“Furthermore, congenital heart disease patients require lifelong monitoring, preventive care and specialized treatment all the way from childhood to adulthood.”

The Harmony TPV device is available for use in the US. The device is limited to investigational use and not approved for sale or distribution outside the US.

Recently, Medtronic has received the CE Mark approval for its SenSight directional lead system for deep brain stimulation (DBS) therapy.