Harmony FDA approval allows Medtronic to enter fresh TPVR space

GlobalData Healthcare 1 April 2021 (Last Updated April 1st, 2021 16:32)

In the increasingly competitive space of medical devices, companies are desperate to find new markets and growth opportunities. When one presents itself, there is a frenzied flurry of market acquisition and research and development (R&D) to ensure that the biggest players can enter the space to fully exploit the growth in revenue that can happen.

Harmony FDA approval allows Medtronic to enter fresh TPVR space
Transcatheter pulmonary valve replacement (TPVR) is being heralded as a much less intensive surgery than the standard alternative, open-heart surgery. Credit: Africa Studio / Shutterstock.

In the increasingly competitive space of medical devices, companies are desperate to find new markets and growth opportunities. When one presents itself, there is a frenzied flurry of market acquisition and research and development (R&D) to ensure that the biggest players can enter the space to fully exploit the growth in revenue that can happen. This was the case with transcatheter aortic valve replacement (TAVR) in recent years, and now it seems like the way is paved for transcatheter pulmonary valve replacement (TPVR) as well.

Just last Friday (26 March), the US Food and Drug Administration (FDA) announced its approval for Medtronic’s Harmony TPVR device. This means that there are now only three or four approved devices in this nascent market, which is preparing to explode.

TPVR is being heralded as a much less intensive surgery than the standard alternative, open-heart surgery. This means that it will ideally result in lower recovery times, have shorter surgery times leading to fewer complications, and have fewer long-lasting effects. At the moment, its surgical competitor is open-heart surgery, which requires the patient to undergo cardioplegia (stopping of the heart) and to be put on cardiopulmonary bypass equipment (CABG). This results in a long recovery time, and there is some evidence of patients who undergo this treatment suffering from a chronic deterioration of their mental state known as ‘pump head’.

Open-heart surgery is already on the decline as it is being replaced with less-invasive surgeries across the field. These include TAVR, transcatheter mitral valve repair (TMVR) and now TPVR. GlobalData predicts that the rise of TPVR will cause a sharper fall in the already declining CABG market. This means that TPVR already has a large patient pool to cannibalise. When coupled with the high technological ‘moat’ that will give other competitors a hard time entering the field, this will result in a huge boost in revenue and market growth for those in the TPVR field for years to come.