Merit Medical Systems announces four regulatory approvals

Merit Medical Systems announces four regulatory approvals

Press releases may be edited for formatting or style | February 21, 2020 Cardiology Endoscopy Operating Room
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.

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.

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“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.

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 in excess of 300 individuals. Merit employs approximately 6,400 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

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