Medtronic announced that the US Food and Drug Administration (FDA) has approved its Harmony Transcatheter Pulmonary Valve (TPV) therapy as a first-of-its-kind minimally invasive therapy. It is designed to treat patients with a particular type of congenital heart defect of the right ventricle (RV), which makes the passing of blood difficult from the heart to the lungs.
Medtronic (MDT) said that the approval followed clinical trials, which showed Harmony TPV’s significant efficacy. Additionally, data from the study demonstrated the treatment’s safety and favorable tolerability profile in patients with no major reinterventions, reoperations, or endocarditis at six months. Shares of the medical device company rose 1.7% on March 26 to close at $118.56.
FDA’s Breakthrough Device Designation (BDD) program designated the Harmony TPV as a Breakthrough Therapy, the approval of which gives patients timely access to certain life-saving technologies. Notably, Harmony TPV is placed inside a patient’s native anatomy during a catheter-based procedure. (See Medtronic stock analysis)
Congenital heart disease (CHD), affecting an estimated 40,000 infants each year in the US, is the most common type of birth defect. Furthermore, currently, about 1.6 million adults are suffering from congenital heart disease.
Medtronic’s Structural Heart & 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,” Goodheart added.
On March 17, Oppenheimer analyst Steven Lichtman reiterated a Buy rating and a price target of $134 (13% upside potential) on the stock, following the Oppenheimer annual healthcare conference, Virtual Edition, which “featured range of topics including latest COVID-19 trends, diabetes pipeline, mitral valve replacement/repair progress, AF pipeline, as well as the large renal denervation opportunity.”
The consensus rating among analysts is a Strong Buy based on 13 Buys versus 1 Hold. The average analyst price target stands at $133.14 and implies upside potential of 12.3% to current levels over the next 12 months. Shares have gained 28.8% over the past year.