Merit Medical Receives 510(K) Approval for Embocube™ Embolization Gelatin for Embolization of Hypervascular Tumors
EmboCube brings speed, precision and consistency to gelatin foam.
SOUTH JORDAN, Utah – November 29, 2018 – Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in interventional, diagnostic and therapeutic procedures, announces that it has received 510(k) clearance for EmboCube Embolization Gelatin.
EmboCube is indicated for use in embolization of hypervascular tumors. The uniformly cut cubes of gelatin foam have been specifically designed to address preparation concerns and inconsistent particle sizes associated with using traditional gelatin foam sheets as an embolic. EmboCube is preloaded in a Medallion® syringe for smooth delivery with minimal to no resistance.
Using traditional gelatin foam sheets as an embolic agent requires the physician to manually prepare the gelatin foam before use, which can be messy and time consuming, and can result in inconsistently sized particles that may clog the delivery catheter or lead to nontargeted embolization.
“I have witnessed many times physicians preparing gelatin foam for endovascular use. They often use a scalpel to cut the gelatin foam, which can be dangerous, and no matter how carefully cut, the particle sizes are inconsistent,” said Fred Lampropoulos, Chairman and CEO of Merit Medical. “We designed EmboCube to make the process of using a gelatin embolic faster, easier and more efficient so the physician can focus on the patient.”
EmboCube Embolization Gelatin is available in two sizes, 2.5 mm and 5.0 mm. The 2.5-mm EmboCube is compatible with the EmboCath® Plus and Merit Maestro® microcatheters with a 0.024” (0.62 mm) or larger inner diameter. The 5.0-mm EmboCube can be delivered through catheters with a 0.040” (1.02 mm) or larger inner diameter. EmboCube is intended for use with an EmboCube Delivery Kit, also by Merit Medical, that includes two injection syringes (1 mL and 3 mL) and a 3-way stopcock for added convenience.
More information about EmboCube may be found on Merit Medical’s website.
About Merit Medical
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 is committed to furthering the growth of radial access through its specialized education program, ThinkRadial®, and a full suite of tailored devices for peripheral and cardiology radial procedures. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 290 individuals. Merit employs approximately 5,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore.
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