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Merit Medical Reports Strong Real-World Data for WRAPSODY Device
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Key Takeaways
Merit Medical's WRAPSODY achieved 92.7% TLPP and 76.7% ACPP at six months, surpassing WAVE trial results.
The WRAP Global registry assessed WRAPSODY in 237 AVF patients across 31 sites in nine countries.
WRAPSODY's strong results may drive physician adoption and support expansion in the dialysis access market.
Merit Medical Systems (MMSI - Free Report) recently announced positive real-world clinical data from the arteriovenous fistula (AVF) cohort of its WRAPSODY Global registry. The WRAPSODY Cell-Impermeable Endoprosthesis (CIE) demonstrated six-month target lesion primary patency (TLPP) of 92.7% and access circuit primary patency (ACPP) of 76.7%. Both results exceeded the corresponding outcomes from the WAVE pivotal trial, reinforcing the device's favorable performance in routine clinical practice.
Per management, the WRAPSODY clinical evidence program combines rigorous clinical trials with real-world data to build comprehensive clinical evidence. The company aims to help physicians preserve vascular access and reduce repeat interventions for hemodialysis patients worldwide.
MMSI Stock Trend Following the News
Shares of MMSI have lost 1.7% since the announcement on Nov. 5. Year to date, the stock has inched down 0.1% against the industry’s 22% growth and the S&P 500’s 10.2% rise.
The encouraging real-world results could support wider physician adoption of WRAPSODY and strengthen MMSI's position in the dialysis access market. Consistent clinical performance may help the company gain traction among healthcare providers seeking durable vascular access solutions, while the growing body of clinical evidence could support further commercial expansion. This positions WRAPSODY as an important contributor to Merit Medical's long-term growth opportunities.
MMSI currently has a market capitalization of $5.26 billion.
Image Source: Zacks Investment Research
More on WRAPSODY CIE
The WRAPSODY CIE is designed to restore vascular access functionality in hemodialysis patients experiencing stenosis or occlusion, conditions that restrict blood flow through an arteriovenous fistula. Maintaining a functional AVF is critical for patients requiring regular dialysis, as access complications can lead to repeated procedures andresult in life-threatening consequences.
The WRAP Global registry is an international, multicenter, prospective study evaluating WRAPSODY CIE performance in routine clinical practice over 24 months following device placement. The AVF cohort included 237 patients across 31 sites in nine countries. The six-month TLPP and ACPP rates of 92.7% and 76.7%, respectively, compared favorably with the WAVE pivotal trial results of 89.8% and 72.8%.
The WRAPSODY CIE received FDA premarket approval in December 2024 and Health Canada approval in April 2025. Merit Medical began U.S. commercialization in January 2025. The device also holds the CE Mark and is available in the European Union and Brazil.
Beyond the WRAP Global registry, Merit Medical is evaluating the device through the WRAP North America registry, which is designed to enroll up to 250 patients across the United States and Canada. Together with the WAVE pivotal trial, these studies are expected to generate an extensive body of clinical evidence on WRAPSODY's performance in dialysis access.
Industry Prospects Favoring the Market
According to Grand View Research, the global vascular access procedures market is estimated to reach $99.6 billion in 2026 and is projected to witness a CAGR of 5.3% through 2030.
Factors such as the rising prevalence of chronic kidney disease and end-stage renal disease, growing demand for hemodialysis, increasing need for long-term vascular access and advancements in minimally invasive vascular access treatments are driving market growth.
Other News
Merit Medical recently acquired Solo Pace, Inc. for approximately $45 million, adding temporary pacing technologies for transcatheter aortic valve replacement (TAVR) and other transcatheter heart valve (THV) procedures. The acquisition expands MMSI’s Cardiac Therapies platform with the SOLO PACE CONTROL and FUSION systems, strengthening its structural heart portfolio and broadening its offerings to support minimally invasive valve procedures.
Some better-ranked stocks from the broader medical space are Glaukos (GKOS - Free Report) , Intuitive Surgical (ISRG - Free Report) and West Pharmaceutical Services (WST - Free Report) .
Glaukos, currently flaunting a Zacks Rank #1 (Strong Buy), reported third-quarter 2026 adjusted earnings per share (EPS) of 47 cents, which surpassed the Zacks Consensus Estimate by 491.7%. Revenues of $211 million beat the Zacks Consensus Estimate by 25%. You can see the complete list of today’s Zacks #1 Rank stocks here.
GKOS has an estimated earnings growth rate of 155.6% for 2026. The company’s earnings beat estimates in three of the trailing four quarters and missed once, the average surprise being 138.6%.
Intuitive Surgical, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2026 adjusted EPS of $3.00, which beat the Zacks Consensus Estimate by 13.6%. Revenues of $3.05 billion surpassed the Zacks Consensus Estimate by 4.9%.
Intuitive Surgical has a long-term estimated growth rate of 15.5%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.1%.
West Pharmaceutical, currently carrying a Zacks Rank #2, reported a third-quarter 2026 adjusted EPS of $2.66, which surpassed the Zacks Consensus Estimate by 22%. Revenues of $874.5 million beat the Zacks Consensus Estimate by 5.9%.
WST has an estimated long-term earnings growth rate of 17.4%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 18.6%.
View the Zacks #1 Rank List
Image: Bigstock
Merit Medical Reports Strong Real-World Data for WRAPSODY Device
Key Takeaways
Merit Medical Systems (MMSI - Free Report) recently announced positive real-world clinical data from the arteriovenous fistula (AVF) cohort of its WRAPSODY Global registry. The WRAPSODY Cell-Impermeable Endoprosthesis (CIE) demonstrated six-month target lesion primary patency (TLPP) of 92.7% and access circuit primary patency (ACPP) of 76.7%. Both results exceeded the corresponding outcomes from the WAVE pivotal trial, reinforcing the device's favorable performance in routine clinical practice.
Per management, the WRAPSODY clinical evidence program combines rigorous clinical trials with real-world data to build comprehensive clinical evidence. The company aims to help physicians preserve vascular access and reduce repeat interventions for hemodialysis patients worldwide.
MMSI Stock Trend Following the News
Shares of MMSI have lost 1.7% since the announcement on Nov. 5. Year to date, the stock has inched down 0.1% against the industry’s 22% growth and the S&P 500’s 10.2% rise.
The encouraging real-world results could support wider physician adoption of WRAPSODY and strengthen MMSI's position in the dialysis access market. Consistent clinical performance may help the company gain traction among healthcare providers seeking durable vascular access solutions, while the growing body of clinical evidence could support further commercial expansion. This positions WRAPSODY as an important contributor to Merit Medical's long-term growth opportunities.
MMSI currently has a market capitalization of $5.26 billion.
Image Source: Zacks Investment Research
More on WRAPSODY CIE
The WRAPSODY CIE is designed to restore vascular access functionality in hemodialysis patients experiencing stenosis or occlusion, conditions that restrict blood flow through an arteriovenous fistula. Maintaining a functional AVF is critical for patients requiring regular dialysis, as access complications can lead to repeated procedures andresult in life-threatening consequences.
The WRAP Global registry is an international, multicenter, prospective study evaluating WRAPSODY CIE performance in routine clinical practice over 24 months following device placement. The AVF cohort included 237 patients across 31 sites in nine countries. The six-month TLPP and ACPP rates of 92.7% and 76.7%, respectively, compared favorably with the WAVE pivotal trial results of 89.8% and 72.8%.
The WRAPSODY CIE received FDA premarket approval in December 2024 and Health Canada approval in April 2025. Merit Medical began U.S. commercialization in January 2025. The device also holds the CE Mark and is available in the European Union and Brazil.
Beyond the WRAP Global registry, Merit Medical is evaluating the device through the WRAP North America registry, which is designed to enroll up to 250 patients across the United States and Canada. Together with the WAVE pivotal trial, these studies are expected to generate an extensive body of clinical evidence on WRAPSODY's performance in dialysis access.
Industry Prospects Favoring the Market
According to Grand View Research, the global vascular access procedures market is estimated to reach $99.6 billion in 2026 and is projected to witness a CAGR of 5.3% through 2030.
Factors such as the rising prevalence of chronic kidney disease and end-stage renal disease, growing demand for hemodialysis, increasing need for long-term vascular access and advancements in minimally invasive vascular access treatments are driving market growth.
Other News
Merit Medical recently acquired Solo Pace, Inc. for approximately $45 million, adding temporary pacing technologies for transcatheter aortic valve replacement (TAVR) and other transcatheter heart valve (THV) procedures. The acquisition expands MMSI’s Cardiac Therapies platform with the SOLO PACE CONTROL and FUSION systems, strengthening its structural heart portfolio and broadening its offerings to support minimally invasive valve procedures.
Merit Medical Systems, Inc. Price
Merit Medical Systems, Inc. price | Merit Medical Systems, Inc. Quote
MMSI’s Zacks Rank & Key Picks
Currently, MMSI carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Glaukos (GKOS - Free Report) , Intuitive Surgical (ISRG - Free Report) and West Pharmaceutical Services (WST - Free Report) .
Glaukos, currently flaunting a Zacks Rank #1 (Strong Buy), reported third-quarter 2026 adjusted earnings per share (EPS) of 47 cents, which surpassed the Zacks Consensus Estimate by 491.7%. Revenues of $211 million beat the Zacks Consensus Estimate by 25%. You can see the complete list of today’s Zacks #1 Rank stocks here.
GKOS has an estimated earnings growth rate of 155.6% for 2026. The company’s earnings beat estimates in three of the trailing four quarters and missed once, the average surprise being 138.6%.
Intuitive Surgical, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2026 adjusted EPS of $3.00, which beat the Zacks Consensus Estimate by 13.6%. Revenues of $3.05 billion surpassed the Zacks Consensus Estimate by 4.9%.
Intuitive Surgical has a long-term estimated growth rate of 15.5%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.1%.
West Pharmaceutical, currently carrying a Zacks Rank #2, reported a third-quarter 2026 adjusted EPS of $2.66, which surpassed the Zacks Consensus Estimate by 22%. Revenues of $874.5 million beat the Zacks Consensus Estimate by 5.9%.
WST has an estimated long-term earnings growth rate of 17.4%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 18.6%.