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Merit Medical Systems Announces Four Regulatory Approvals
SOUTH JORDAN, Utah, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary
About this update from Merit Medical Systems, Inc.
[{"type":"text","content":"SOUTH JORDAN, Utah, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, announced today that regulatory clearances have been issued with respect to four products Merit owns or holds the rights to distribute.\n Merit received clearance from the China National Medical Products Association (NMPA) to market the Swift Ninja™ Steerable Microcatheter in China. This device previously received clearance in the United States as well as the European Union (CE mark). The Swift Ninja has received strong reviews for its time efficiency as well as the ability to employ its steerable characteristics to access difficult or tortuous anatomy. Secondly, the NMPA also gave Merit clearance to market in China the InQwire® Amplatz Guide Wire, which has been selling successfully in the United States and Europe. “Although it has taken some time to receive these approvals, they are complementary to our peripheral product offering, especially our embolic products,” said Fred P. Lampropoulos, Merit’s Chairman and CEO. Thirdly, Merit received the CE mark for its Cianna Scout® Surgical Guidance System. Initial procedures utilizing the Scout Surgical Guidance System have been completed in Great Britain with preparations to launch the Scout Surgical Guidance System throughout the EU over the next several weeks. “In an environment where international approvals are becoming more difficult to obtain, we are pleased to add these to our product portfolio,” Lampropoulos said. Finally, Merit received notice from BlueGrass Vascular Technologies, Inc. (Bluegrass Vascular) that the FDA has granted to Bluegrass Vascular a De Novo classification order for its Surfacer® Inside-Out® Access Catheter System. Merit owns approximately 19% of the common equity of BlueGrass Vascular and has been the worldwide exclusive distributor of the system for the last three years. Merit has the option to acquire the remaining equity of Bluegrass Vascular within the next two months. Merit plans to evaluate the Surfacer Inside-Out System in several U.S. accounts and feature the system at the Society of Interventional Radiology (SIR) meetings scheduled to take place in Seattle March 28-April 2. Additional information about the Surfacer Inside-Out...