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Merit Medical Expands Embolics Portfolio with New Siege™ Vascular Plug and Bearing nsPVA Express™ Prefilled Syringe

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Merit Medical (NASDAQ: MMSI) has expanded its embolics portfolio with the FDA-cleared Siege Vascular Plug and the launch of Bearing nsPVA Express Prefilled Syringe in the US and Australia. These products complement existing microsphere, particle, and foam offerings. The Siege Vascular Plug, available in three sizes, offers rapid vessel occlusion within 1.3 minutes, enhancing precision in peripheral artery treatments. The Bearing nsPVA Express, a 20-mL prefilled syringe, simplifies procedures by saving time and reducing waste. Both products will be showcased at the 18th Annual GEST Meeting (May 16-19, 2024) in New York, where Merit will also exhibit other embolic solutions and delivery systems.

Positive
  • FDA 510(k) clearance for Siege Vascular Plug.
  • Launch of Bearing nsPVA Express Prefilled Syringe in US and Australia.
  • Siege Vascular Plug achieves vessel occlusion within 1.3 minutes.
  • Bearing nsPVA Express simplifies procedures, saving time and minimizing waste.
  • 100% of clinicians found Bearing nsPVA Express easy to use.
  • Participation and product showcasing at the 18th Annual GEST Meeting.
  • Merit's commitment to innovation, education, and research in embolotherapy.
Negative
  • No specific negative aspects reported in the press release.

Insights

Merit Medical's recent FDA 510(k) clearance for its Siege Vascular Plug and the launch of the Bearing nsPVA Express Prefilled Syringe are significant milestones. The clearance from the FDA is a green light, suggesting that the product is safe and effective for its intended use. This could potentially boost the company's revenue by increasing its product offerings in the rapidly growing embolotherapy market.

In the short term, investors might expect a positive reaction in the company's stock price due to the immediate market opportunity presented by these new products. However, it is essential to consider the competitive landscape and how these products will perform against existing solutions from other companies. Long-term growth will depend on Merit Medical's ability to capitalize on this opportunity through effective marketing and adoption by medical professionals.

The fact that these products complement the company's existing range strengthens its market position, making it more attractive to hospitals and healthcare providers who prefer comprehensive solutions from a single supplier. This could lead to more consistent revenue streams and potentially higher margins as the company leverages existing customer relationships and sales channels.

The introduction of the Siege Vascular Plug and Bearing nsPVA Express Prefilled Syringe highlights Merit's commitment to advancing embolotherapy. The Siege Vascular Plug's ability to occlude vessels within 1.3 minutes is particularly noteworthy as it addresses a critical need for speed and precision in minimally invasive procedures. This feature can be important in emergency scenarios where quick intervention is needed to stop bleeding or block blood flow to a tumor.

Additionally, the Bearing nsPVA Express Prefilled Syringe offers a practical benefit by reducing preparation time and minimizing waste. This not only enhances procedural efficiency but also potentially improves patient outcomes by reducing the risk of errors and contamination. Physicians' positive feedback further supports the clinical value of these innovations.

From a broader perspective, these advancements could lead to wider adoption of embolotherapy, a market that is already growing due to the increasing preference for minimally invasive procedures. This could have a ripple effect, driving further innovations and improvements in related medical technologies.

  • New products broaden Merit’s leadership in embolotherapy.
  • Full portfolio will be exhibited at the 18th Annual GEST Meeting May 16-19 in New York City.

SOUTH JORDAN, Utah, May 14, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced US Food and Drug Administration (FDA) 510(k) clearance for its Siege Vascular Plug. Merit also announced the launch of its Bearing nsPVA Express Prefilled Syringe in the United States and Australia.

The latest additions to Merit’s Embolics portfolio, Siege Vascular Plug and Bearing nsPVA Express, complement a comprehensive offering of microsphere, particle, and gelatin foam products supported by a range of microcatheters, guide wires, and other enabling devices.

Embolization is a minimally invasive procedure where physicians implant devices or materials to occlude blood vessels or abnormal vascular channels. It may be used to stop bleeding or to block the flow of blood to a tumor or abnormal area of tissue. Embolization has made remarkable advances in recent years, becoming a widely adopted treatment option.

The Siege Vascular Plug has a highly deliverable, recapturable design that enables precise placement. The nitinol self-expanding plug achieves vessel occlusion within 1.3 minutes.Available in three sizes, Siege treats peripheral arteries 1.5 mm to 6.0 mm in diameter. All sizes of the Siege Vascular Plug are delivered with a microcatheter.

“The Siege Vascular Plug will be a valuable addition to my clinical practice. A plug with rapid occlusion, precise placement, and microcatheter compatibility is important to me,” said Gary Siskin, MD, Professor and Chairman of the Radiology Department at Albany Medical Center in Albany, NY, and paid consultant of Merit.

The newly launched Bearing nsPVA Express is a 20-mL, vacuum-sealed syringe prefilled with Merit-manufactured Bearing nsPVA® Embolization Particles. Bearing nsPVA Embolization Particles are small, irregularly shaped, biocompatible, hydrophilic, and nonresorbable particles available in multiple sizes (45-1180 µm). The preloaded syringe offers convenience and ease of use that can save clinicians’ time and minimize product waste. In hands-on testing, 100% of clinicians found the Bearing nsPVA Express to be easily incorporated into a procedure, and 75% said it was easier to use than the vial product.1

“Bearing nsPVA Express streamlines embolization procedures. It eliminates a number of steps involved in using PVA in a vial,” said Jafar Golzarian, MD, Interventional Radiologist and Founder at Northstar Vascular and Interventional in Golden Valley, MN. “Unlike vial products, it’s ready to use, enabling interventional radiologists to focus on the procedure.”

As part of its commitment to innovation, education, and research in embolotherapy, Merit will participate in the 18th Annual Global Embolization Oncology Symposium Technologies (GEST) Meeting, to be held May 16-19, 2024, in New York City, NY. In addition to introducing the Siege Vascular Plug and Bearing nsPVA Express, Merit will be exhibiting other embolic product solutions, including Embosphere® Microspheres, EmboCube™ Embolization Gelatin, and Torpedo™ Gelatin Foam. Merit will also feature the SwiftNINJA® Steerable Microcatheter and the longer-length Merit Maestro® Microcatheter; both delivery systems are ideal for radial procedures.

Physicians can try these products through hands-on workshops held at the Merit booth. GEST attendees will also have access to Merit’s simulator for added prostatic artery embolization and uterine fibroid embolization experience involving Embosphere Microspheres and other Merit devices.

“Merit is a leader in embolotherapy,” said Fred P. Lampropoulos, Merit Chairman and Chief Executive Officer. “Through continued investment in new product solutions, we have developed a strong record of delivering meaningful innovation, new indications, and portfolio extensions designed to meet the needs of our healthcare partners. We look forward to demonstrating this excellence at GEST, showcasing the ways we help physicians deliver a better patient experience.”

ABOUT MERIT MEDICAL

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling over 700 individuals. Merit employs approximately 7,000 people worldwide.

TRADEMARKS
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.

CONTACTS 
PR/Media Inquiries 
Sarah Comstock 
Merit Medical 
+1-801-432-2864 | sarah.comstock@merit.com 

INVESTOR INQUIRIES 
Mike Piccinino, CFA, IRC 
Westwicke - ICR 
+1-443-213-0509 | mike.piccinino@westwicke.com

1. Data on File.

 


FAQ

What new products did Merit Medical (MMSI) introduce in May 2024?

Merit Medical introduced the Siege Vascular Plug and Bearing nsPVA Express Prefilled Syringe.

What is the purpose of the Siege Vascular Plug?

The Siege Vascular Plug is designed for rapid and precise vessel occlusion, treating peripheral arteries 1.5 to 6.0 mm in diameter.

Which regions are the Bearing nsPVA Express Prefilled Syringe launched?

The Bearing nsPVA Express Prefilled Syringe is launched in the United States and Australia.

How fast does the Siege Vascular Plug occlude vessels?

The Siege Vascular Plug achieves vessel occlusion within 1.3 minutes.

Where will Merit Medical showcase its new embolic products?

Merit Medical will showcase its new embolic products at the 18th Annual GEST Meeting, held from May 16-19, 2024, in New York City.

What are the benefits of using the Bearing nsPVA Express Prefilled Syringe?

The Bearing nsPVA Express Prefilled Syringe simplifies procedures by saving time and reducing product waste.

Merit Medical Systems Inc

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