Medtronic has announced the relaunch of its Harmony transcatheter pulmonary valve (TPV) system, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT).
Harmony TPV was designed to treat patients with RVOT anomalies who develop severe pulmonary valve regurgitation.
“For congenital heart disease patients with severe pulmonary valve regurgitation, utilising a valve that works with their anatomy is key to preventing risks such as right-sided heart failure, and optimising outcomes while minimising the disruption to their lives,” said Matthew J Gillespie (Children’s Hospital of Philadelphia, Philadelphia, USA). “I am pleased to be able to once again offer Harmony TPV as an option to patients who require pulmonary valve replacement.”
The Harmony TPV System received US Food and Drug Administration (FDA) approval in 2021 based on the Harmony TPV clinical study that demonstrated safety and effectiveness up to six months with no significant reinterventions.
Medtronic initiated a voluntary recall of the Harmony Delivery Catheter System (DCS) in March 2022 due to six reported cases of the bond holding the capsule at the end of the delivery catheter breaking. Medtronic worked collaboratively with the FDA to remediate the issue and earn FDA approval to return the device to market.
The Harmony TPV device is now commercially available for use in the USA and has received regulatory approval in Japan.
