Recently, Meritone announced that its cell-impermeable stent---Wrapsody was approved by the FDA for marketing. This is the first product approved by the FDA for the treatment of vascular access stenosis or thrombosis in hemodialysis patients. It is reported that Meritone will start commercialization in the United States next year.

Founded in 1987, Meritone is a leading medical device manufacturer that produces devices used in cardiac and radiological interventional surgery. Meritone's product line includes interventional filling devices and accessories, diagnostic and therapeutic catheters and guidewires, disposable pressure monitoring equipment, contrast agent management systems, non-vascular stents, thrombolytic catheters and syringes and needles. The company is committed to meeting the needs of global cardiology and radiology experts through product research and development and high-quality production.

Hemodialysis is currently the most widely used blood purification treatment method, suitable for most patients with acute and chronic renal failure. According to statistics and forecasts from Global Info Research, the global hemodialysis market sales reached $12.054 billion in 2022 and are expected to reach $18.129 billion in 2029, with a CAGR of 6.17% from 2023 to 2029.

However, complications such as AVF or AVG can lead to stenosis or occlusion in the dialysis outflow circuit, which can damage the vascular access, thereby reducing dialysis efficiency or even rendering the vascular access useless.

Against this background, Meriton launched its blockbuster product, the cell-impermeable coated stent - Wrapsody, which is a cell-impermeable endoprosthesis used to prolong long-term vascular patency in dialysis patients.

In addition, Wrapsody also uses a unique three-layer structure. The outermost layer is standard ePTFE, which allows the necessary tissue to grow inward to prevent the stent from shifting; the middle layer adjacent to the nitinol stent is a cell-impermeable fluoropolymer, which is used to prevent cells from migrating across the wall through the graft cover layer and avoid the use of drug coatings; the innermost layer is spun PTFE, which is designed to reduce fibrin deposition and subsequent thrombosis without the need for coatings, chemicals or drugs.

In addition, Wrapsody's end-row design has a smaller radial force to better conform to healthy tissue, reduce vascular damage, and improve long-term patency. The nitinol stent allows for up to 25% lift to achieve better vascular consistency. Wrapsody withstands intraluminal forces and external pressures applied to the device and is consistent across all diameter sizes.

According to the data from the previous Wrapsody pivotal clinical study (WAVE), Wrapsody can not only solve the problem of vascular access stenosis, but also reduce the problem of stent restenosis, maintaining a high patency rate of 88.6% after surgery.

In this regard, Fred P. Lampropoulos, Chairman and CEO of Meritone, said that he was very proud to design and deliver such an innovative solution, which has proven to be the highest efficacy to date.

On the 17th of this month, Meritone also suddenly announced a personnel change. Its president, Joseph C. Wright, resigned, which will take effect on January 3, 2025. It is understood that Joseph C. Wright resigned after unspecified allegations about his behavior were exposed. Meritone conducted an independent investigation into these allegations and said that these allegations were not related to the company's "operational or financial performance."

The position of president once again fell to Fred P. Lampropoulos, Chairman and CEO of Meritone. As one of the founders of Meritone, Lampropoulos has been very successful in his leadership since 1987, and has been leading Meritone from a start-up to a global leading medical device giant.

Under the guidance of Lampropoulos, Merit Endotek's products are currently sold in six core product categories, including peripheral intervention products, cardiac intervention products, cardiovascular and critical care products, interventional oncology and spine products, breast cancer positioning and guidance products, and endoscopy. Its specific product types are as follows:

Endoscopy: The products of the endoscopy department Merit Endotek™ are aimed at gastrointestinal, lung and thoracic surgery. The product portfolio includes: non-vascular stents, dilatation balloons, NvisionVLE® advanced imaging systems, and kits and accessories for endoscopic and bronchoscopic procedures;

Peripheral intervention products: Peripheral intervention products are used to diagnose and treat peripheral vascular and organ diseases other than the heart. The product portfolio includes access, angiography, intervention, biopsy, drainage and solutions;

Interventional Cardiac Products: The product portfolio of interventional cardiac products includes access, angiography, hemostasis, intervention, interventional fluid management, pressure monitoring, thermodilution and pulmonary artery catheters, as well as electrophysiology and rhythm management;

Cardiovascular and Critical Care Products: These products are used to treat life-threatening diseases and protect healthcare providers and patients from exposure to blood-borne pathogens. The product portfolio is mainly divided into two categories: interventional fluid management and pressure monitoring;

Interventional Oncology and Spine Products: These products can be used to treat vertebral compression fractures, metastatic spinal tumors, liver cancer, uterine fibroids, symptomatic benign prostatic hyperplasia, arteriovenous malformations and hemostatic embolism. The product portfolio includes delivery systems, embolization therapy, spinal ablation, angiography and vertebral compression fractures;

Breast cancer positioning and guidance products: Breast cancer positioning and guidance products are used for innovative treatment of early breast cancer. The product portfolio includes: SCOUT radar positioning system, SAVI brachytherapy, SCOUT surgical kit, conical sheath, ultrasound delivery system, etc.

In addition to the above core products, Meriton also provides proprietary surgical products, including Fibrovein® drugs for the treatment of varicose veins, medical tube and wire coating services for OEM brands, and micro-electromechanical system sensor components composed of piezoresistive sensors.

In addition, Meriton has also been very active this year: In June, Meriton reached a cooperation with Medtronic to provide it with a single steerable balloon catheter for the treatment of minimally invasive vertebral compression fractures (VCF) - Kyphon KyphoFlex; On November 1, it acquired Cook Medical's lead management product portfolio for US$210 million to consolidate the electrophysiology and cardiac rhythm management business and enhance its position in the global cardiac intervention market.

Although there was a small episode of changing leadership at the end of 2024, looking at the whole 2024, Meritone continued to maintain a high-speed development trend and move forward rapidly. What kind of wonderful performance will Meritone bring in the future? It is worth looking forward to.