Medtronic obtained FDA approval for its Melody Transcatheter Pulmonary Valve (TPV) in 2017, and the device has been deployed in the treatment of severe pulmonary regurgitation outside of the United States for more than a decade. On March 26, Medtronic announced that the FDA had approved its latest TPV system, Harmony. With this addition, Medtronic strengthens its portfolio and provides more treatment options for patients who are not good candidates for invasive surgery.
Medtronic is the largest medical device company and is already established in this space with multiple catheter valve therapies. Medtronic has positioned itself to dominate the POS market, but an analysis of the company’s performance over the past five years shows that its US revenues in this market have remained stagnant. This is probably due to the fact that pulmonary regurgitation (RP) is often an asymptomatic disease. Historically, RP has been managed by treating symptoms and only turning to valve repair or replacement when necessary.
Medtronic will seek to offset the challenges in this market by further studying the benefits of earlier intervention in PR to alleviate other diseases, such as pulmonary hypertension and heart failure. In addition, Medtronic will likely support further investigations into the diagnosis of RP, which is typically detected using Doppler echocardiography.
Mitral regurgitation (MR) has recently received wide coverage due to the rapid growth in the market for catheter mitral valve implantation and repair devices. Historically, MR was only treated by treating symptoms due to age in patients who usually develop MR, which increases the risk of complications in open heart surgery. Catheter therapy has increased the rate of MRI procedures. As such, Medtronic’s POS devices could follow similar footsteps if they can handle the associated challenges in the market.