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Merit Medical WRAPSODY Gets 2 FDA Breakthrough Device Nods

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Merit Medical Systems MMSI was recently granted two additional Breakthrough Device designations by the FDA for the Merit WRAPSODY Endovascular Stent Graft System. The system is a flexible, self-expanding endoprosthesis.

Last November, the system had attained the first Breakthrough Device designation by the FDA.

This regulatory clearance is expected to bolster the company’s cardiovascular segment.

More About Merit WRAPSODY

The indications for use of the system have been expanded for treatment of stenosis or occlusion within the dialysis outflow circuit, including stenosis or occlusion within the peripheral veins in the arm of Arteriovenous Fistula (AVF) patients, and within the thoracic central veins, up to the superior vena cava, in Arteriovenous Graft (AVG) patients. If the system receives FDA clearance, the company is hopeful that the expanded indications will ensure enhanced access to this life-saving technology.

Notably, the WRAPSODY system is not being currently sold in markets.

Market Prospects

Per a report published on Future Market Insights, the global aortic stent grafts market is expected to see a CAGR of 7.6% over the forecast period of 2018-2028, and is anticipated to reach a worth of $4.81 billion by 2028-end. Hence, this FDA designation comes at an opportune time.

Recent Developments

Lately, the company has been attaining several regulatory clearances, which have been boosting its product portfolio.

In February 2020, the company received clearance from the China National Medical Products Association (“NMPA”) to market the Swift Ninja Steerable Microcatheter in China. The NMPA also gave the company a go-ahead to market in China the InQwire Amplatz Guide Wire, which has seen success in the United States and Europe. The company also received CE mark for its Cianna Scout Surgical Guidance System.

Price Performance

In the past six months, the stock has rallied 18.3% against the 10.7% decline of its industry.

Zacks Rank and Other Key Picks

Merit Medical Systems currently sports a Zacks Rank #2 (Buy).

A few other top-ranked stocks from the broader medical space are ResMed Inc. RMD, DexCom DXCM and Integra LifeSciences Inc IART.

ResMed has a projected long-term earnings growth rate of 12%. It currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

DexCom’s long-term earnings growth rate is estimated at 36.7%. The company presently carries a Zacks Rank #2.

Integra’s long-term earnings growth rate is estimated at 11.9%. It currently has a Zacks Rank #2.

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Click to get this free report Integra LifeSciences Holdings Corporation (IART) : Free Stock Analysis Report DexCom, Inc. (DXCM) : Free Stock Analysis Report Merit Medical Systems, Inc. (MMSI) : Free Stock Analysis Report ResMed Inc. (RMD) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research