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news.Merit Medical Systems, a manufacturer and marketer of disposable devices used primarily in cardiology and radiology procedures, has received 510(k) clearance from the FDA for the Prelude short sheath introducer. Sales will commence worldwide in the next few weeks.
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Merit Medical Systems said that this device, which is used primarily for access to dialysis fistulas and grafts, provides several advantages for clinicians, including a marker tip to easily identify the exact placement of the device and an angled large-bore side arm for enhanced removal of blood clots. It will replace an existing product that is currently manufactured by an outside vendor, the company added.
Fred Lampropoulos, Merit’s chairman and CEO, said: “Prior to this introduction, the existing product was available only in the US and Canada. Our new, internally manufactured product has the features and benefits needed for us to become a market leader. We believe this product will allow us to compete worldwide with substantially improved margins in a market that continues to be an area of focus for Merit.”