Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Harmony transcatheter pulmonary valve (TPV) system to treat patients with congenital heart disease.
Harmony TPV is claimed to be the first non-surgical heart valve to treat paediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that takes blood out of the right ventricle to the lungs.
Designed for placement inside a patient’s native anatomy during a catheter-based procedure, the Harmony TPV has secured a breakthrough therapy status under FDA’s breakthrough device designation (BDD) programme.
The device will help treat patients who have severe pulmonary valve regurgitation, a condition that generally results from congenital heart disease.
Harmony TPV system will allow enhanced blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery.
Medtronic cardiovascular portfolio’s 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 approval is based on clinical data from the Harmony TPV clinical trial, which demonstrated better safety and effectiveness at 30 days and six months. The prospective, non-randomised, multi-centre clinical study evaluated a total of 70 patients.
Data from the study also showed that patients treated with Harmony TPV experienced no significant reinterventions, reoperations or endocarditis at six months, said the company.
The Harmony TPV device, which is currently available for use in the US, is restricted to investigational use and not approved for sale or distribution outside the US.
