Medtronic's Melody TPV Wins FDA for Less-Invasive Treatment
Leading medical device manufacturer Medtronic plc MDT recently won FDA approval for Melody Transcatheter Pulmonary Valve (TPV) for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed. According to Medtronic, this is the first transcatheter pulmonary valve to be approved in the U.S.
When a surgical valve degenerates over time, patients may require another valve replacement, which would involve undergoing another open-heart surgery. The Melody TPV may now provide patients with a minimally invasive treatment option and reduce the need for obtrusive open-heart surgery.
Unlike other transcatheter valves (THVs), Melody TPV is designed for use in pulmonic position and is thus well suited for implantation in failed surgical pulmonary heart valves.
Meanwhile, Medtronic has been trading above the Zacks categorized Medical - Products industry for the last one month. The stock has to date gained 6.8%, higher than the 2.1% increase of the broader industry. The company has also recently achieved CMS coverage approval for its Micra Transcatheter Pacing System. Thus, the recent regulatory approvals are expected to help the company maintain the share price trend in the near term.
Management claimed that the Melody TPV is the first non-surgical option to treat failing pulmonary valve conduits. It has been proved that numerous congenital patients globally have benefited from this therapy. Over the last decade, clinical evidence from three Medtronic clinical studies has demonstrated the valve’s capability in delaying the need for open-heart reoperation.
In Sep 2006, the Melody TPV first received CE Mark and was introduced in the U.S. in 2010.
Medtronic PLC Price
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As per a Grand View Research report, the global transcatheter valve market is expected to reach a worth of $8.62 billion by 2024, at a CAGR of 13.9%. Thus, Medtronic is well positioned to capitalize on its broad and differentiated offering in this market given the huge demand for less-invasive THV implantation.
Zacks Rank & Key Picks
Medtronic currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical product sector are Inogen, Inc. INGN, Bovie Medical Corporation BVX and ResMed, Inc. RMD. Inogen sports a Zacks Rank #1 (Strong Buy) while the other two companies carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Inogen gained 87.3% in the last one year in comparison to the S&P 500’s gain of 16.8%. The company has a stellar four-quarter average earnings surprise of over 49.08%.
Bovie Medical surged 44.7% in the last one year in comparison to the S&P 500. It has a four-quarter average earnings surprise of 28.7%.
ResMed gained over 27.7% in the past one year, better than the S&P 500 mark. It also has a trailing average earnings surprise of 0.31%.
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