Merit Medical Systems, Inc. MMSI recently announced the FDA's premarket approval for the WRAPSODY Cell-Impermeable Endoprosthesis. With this approval, MMSI can begin commercializing the device in the United States in 2025.

In November, Merit Medical unveiled positive six-month findings from the single-arm Arteriovenous Graft cohort of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The WAVE trial was designed to assess the efficacy and safety of the WRAPSODY device.

Likely Trend of MMSI Stock Following the News

Following the announcement, shares of the company moved 2.03% north to $98.22 on Friday. In the past year, MMSI’s shares have gained 29.9% compared with the industry’s growth of 2.2%. The S&P 500 has gained 25.4% in the same time frame.

The FDA approval of the WRAPSODY Cell-Impermeable Endoprosthesis is a significant milestone for Merit Medical as it enables the company to expand its product portfolio into the vascular intervention market, addressing critical needs in dialysis access. This approval enhances Merit Medical’s competitive positioning, opens new revenue streams and strengthens its credibility in the medical device industry. Henceforth, we expect market sentiment to remain positive surrounding this news announcement.

Meanwhile, MMSI currently has a market capitalization of $5.72 billion. The Zacks Consensus Estimate for fiscal 2024 revenues is pegged at $1.35 billion, indicating 7.2% growth from the reported fiscal 2023.

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More on the MMSI’s WRAPSODY Device & Its Positive Study Data

In the United States, numerous procedures are performed annually to maintain dialysis access, with a significant portion involving stent placement to ensure blood flow. While covered stents have enhanced long-term outcomes, issues like stenosis remain common in hemodialysis patients, often caused by tissue buildup within these devices' polytetrafluoroethylene (PTFE) layer. To address this challenge, Merit Medical’s engineers partnered with Dr. Bart Dolmatch, a leading Interventional Radiologist, to develop the WRAPSODY Cell-Impermeable Endoprosthesis, offering a more advanced solution for improving vascular access.

The WRAPSODY device is engineered to enhance long-term vessel patency in dialysis patients, particularly those relying on vascular access sites such as arteriovenous (AV) fistulas or grafts in the arm. These sites are critical for maintaining blood flow and patient survival but are prone to complications like narrowing (stenosis) and blood clot formation (thrombosis) over time.

The WRAPSODY Cell-Impermeable Endoprosthesis incorporates a nitinol stent frame surrounded by multiple layers of advanced PTFE material. This design reduces clotting and prevents tissue migration into the graft, while the nitinol frame enhances strength, flexibility, and vessel conformity. Collectively, these features aim to address complications and support better outcomes for dialysis patients.

The WRAPSODY WAVE pivotal trial demonstrated that AV fistula and AV graft patients receiving treatment with the WRAPSODY device for dialysis outflow lesions achieved a target lesion primary patency of 89.8% and 82.0%, respectively, at six months. The primary patency of the entire access circuit at six months in patients with an AV fistula and AV graft were 72.6% and 68.8%, respectively.

Favorable Industry Prospects of MMSI

Per a report by Allied Market Research, the global hemodialysis market was valued at $76.9 billion in 2022 and is anticipated to reach $111.8 billion by 2032 at a CAGR of 3.8%. Factors like the growing awareness regarding hemodialysis and the increasing prevalence of chronic cardiac diseases and end-stage renal disease are likely to drive the market.

Given the market potential, the latest announcement of the FDA’s approval of the WRAPSODY Device solidifies Merit Medical’s foothold in the niche space.

MMSI’s Zacks Rank & Stocks to Consider

MMSI carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks in the broader medical space are Masimo MASI, Accuray ARAY and Abbott Laboratories ABT.

Masimo, sporting a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 11.8% for 2025. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

MASI’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 17.10%. Its shares have risen 31.7% against the industry’s 1% decline in the past six months.

Accuray, carrying a Zacks Rank #2 at present, has an estimated growth rate of 1200% for 2025. Its earnings missed estimates in three of the trailing four quarters and met in one, delivering an average negative surprise of 141.97%.

ARAY’s shares have gained 8.8% against the industry’s 1% decline in the past six months.

Abbott, carrying a Zacks Rank of 2 at present, has an estimated earnings growth rate of 10% for 2025. It delivered a trailing four-quarter average earnings surprise of 1.64%.

ABT’s shares have risen 8.5% in the past six months compared with the industry’s 7.2% growth.

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