New Steerable Balloon Offers Physicians Bipedicular Results via Unipedicular Access in Balloon-Assisted Vertebral Augmentation
SOUTH JORDAN, Utah – January 29, 2020 – Merit Medical Systems, Inc. announced the official market launch of Arcadia Steerable and Straight Balloons for vertebral augmentation. Arcadia balloons are designed to help physicians achieve controlled, precise cavity creation during unipedicular or bipedicular vertebral augmentation procedures.
The Arcadia Steerable Balloon provides a bipedicular footprint through a unipedicular approach for increased control for ideal balloon placement and cement delivery when treating vertebral compression fractures. The Arcadia Steerable Balloon’s unique design has the potential to reduce procedural and fluoroscopy times and lower costs associated with additional incisions. The Arcadia Straight Balloon is designed for simplified cavity creation when treating vertebral compression fractures via a standard bipedicular approach.
“The Arcadia Steerable Balloon offers highly accurate balloon placement through a unilateral approach, as well as a balloon with enough size and durability to reduce prominent fractures and optimize cement fill,” said Douglas P. Beall, MD, Chief of Services, Clinical Radiology of Oklahoma.* “This system has the capability to offer bilateral results with a unilateral approach. Merit got it right on this one.”
The pre-inflation length of both product offerings – five sizes ranging from 10mm to 30mm – accommodates diverse anatomies while providing reduced compliancy and increased balloon volumes. The size range combined with steerability enables the ability to straddle the center midline of the vertebral body, providing a balanced inflation footprint between endplates. A high-pressure rating of 700psi helps to form even cavity creation in varying vertebral body anatomies.
“The commercial launch of the Arcadia is significant for physicians looking to improve control, safety, and operational ergonomics during vertebral augmentation,” commented Fred Lampropoulos, Chairman and CEO, Merit Medical. “The Steerable Balloon, in particular – with its bipedicular footprint through a unipedicular approach – offers doctors unique and desirable advantages over other devices available on the market today. We look forward to seeing Arcadia find a home in interventional suites and operating rooms across the country, and to hearing real-world success stories from our valued customers.”'
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; San Jose and 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.
* Dr. Beall consulted with Merit as part of its development and early evaluation teams for the Arcadia Steerable Balloon.