The first cell impermeable membrane covered stent has been approved by the FDA for market launch

December 27, 2024  Source: drugdu 31

Recently, Merit Medical announced that its non permeable membrane covered stent, Wrapsody, has been approved by the FDA for sale. This is the first product approved by the FDA for the treatment of vascular stenosis or thrombosis in hemodialysis patients. It is reported that Merit Medical will start commercialization in the United States next year."/The first heavyweight product has been launched
Founded in 1987, Merit Medical is a leading medical device manufacturing enterprise that produces instruments used in cardiac and radiological interventional surgeries. The product line of Merit Medical Company includes interventional filling devices and their accessories, diagnostic and therapeutic catheters and guide wires, disposable pressure monitoring equipment, contrast agent management systems, non vascular stents, thrombolytic catheters, syringes and needles, etc. The company is committed to meeting the needs of global cardiology and radiology experts through product development and high-quality production.

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

However, complications such as AVF or AVG can lead to narrowing or occlusion of the dialysis outflow circuit, which can damage the vascular pathway and reduce dialysis efficiency or even render the vascular pathway useless.

Based on this background, Merit Medical has launched a heavyweight product - Wrapsody, a cell impermeable membrane stent, which is a cell impermeable internal prosthesis used to prolong the long-term vascular patency of dialysis patients.

And Wrapsody also adopts a unique three-layer structure. The outermost layer is standard ePTFE, allowing necessary tissue to grow inward to prevent stent displacement; The middle layer adjacent to the nickel titanium alloy stent is a cell impermeable fluoropolymer, which is used to prevent cells from migrating across the graft cover layer and avoid the use of drug coatings; The innermost layer is spun PTFE, designed to reduce fibrin deposition and subsequent thrombosis without the need for coatings, chemicals, or drugs.

In addition, the end row design of Wrapsody has a smaller radial force to better conform to healthy tissue, reduce vascular damage, and improve long-term patency. The nickel titanium alloy stent allows for a lift of up to 25% to achieve better vascular consistency. The Wrapsody can withstand internal forces within the cavity and external pressure applied to the instrument, and is consistent across all diameter sizes.

According to the previous Wrap Sody Critical Clinical Study (WAVE) data, Wrap Sody not only solves the problem of vascular pathway stenosis, but also reduces stent restenosis, maintaining a high patency rate of 88.6% after surgery.

Regarding this, Fred P. Lampropoulos, Chairman and CEO of Meriton, expressed great pride in designing and delivering such an innovative solution, which has proven to be the most effective to date.

Six core products
On the 17th of this month, Merit Medical suddenly announced a personnel change message. Its CEO Joseph C. Wright has 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, and Meriton conducted an independent investigation into these allegations, stating that they are not related to the company's "operational or financial performance".

The position of CEO has once again fallen to Fred P. Lampropoulos, Chairman and CEO of Meriton. As one of the founders of Meriton, Lampropoulos' leadership has been very successful since 1987, leading Meriton from a startup to a globally leading medical device giant.

Under the guidance of Lampropoulos, currently, Meritus' products are grouped into six core product categories for combined sales, including peripheral intervention products, cardiac intervention products, cardiovascular and intensive care products, interventional tumor and spine products, breast cancer positioning and guidance products, and endoscopy. The specific product types are as follows:
 Endoscopic examination: Merit Endotek, Endoscopy Department ™ Our products are aimed at gastrointestinal, pulmonary, and thoracic surgery. The product portfolio includes: non vascular stents, expansion balloons NvisionVLE ® Advanced imaging systems, as well as kits and accessories for endoscopic and bronchoscopic examination procedures;
 Peripheral intervention products: Peripheral intervention products are used for the diagnosis and treatment of peripheral vascular and organ diseases other than the heart. The product portfolio includes access, angiography, intervention, biopsy, drainage, and solutions;
 Cardiac intervention products: The cardiac intervention product portfolio includes access, angiography, hemostasis, intervention, interventional fluid management, pressure monitoring, thermal dilution and pulmonary artery catheterization, 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: intervention liquid management and pressure monitoring;
 Interventional oncology and spinal 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 embolization. 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, ultrasonic transmission system, etc.

In addition to the core products mentioned above, Merit Medical also offers proprietary surgical products, including Fibroviein for the treatment of varicose veins ® Medications, medical tube and wire coating services for OEM brands, and microelectromechanical system sensor components composed of piezoresistive sensors.

In addition, this year, Merit Medical has also been very active: in June, Merit Medical reached a cooperation with Medtronic to provide a single manipulable balloon catheter for the treatment of minimally invasive vertebral compression fractures (VCF) - Kyphon KyphoFlex; On November 1st, it acquired Cook Medical's wire management product portfolio for $210 million, consolidating its electrophysiological and cardiac rhythm management businesses and enhancing its position in the global cardiac intervention market.

Conclusion
Despite the small incident of changing coaches at the end of 2024, looking at the whole of 2024, Merit Medical continues to maintain a high-speed development trend and move forward rapidly. What kind of wonderful performance will Merit Medical bring in the future? Worth looking forward to.

Source: https://news.yaozh.com/archive/44741.html

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