EOI Announces FDA Clearance for the FLXfit15, the Only 3D Articulated Expandable Cage With 15 degrees of Lordosis Correction
FLXfit™15, unique anatomical fit for sagittal and coronal alignment
OR AKIVA, Israel, September 28, 2017 /PRNewswire/ --
Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced FDA 510(k) clearance for the FLXfit™15, enhancing the already successful FLXfit™ 3D Expandable Cage System. The FLXfit™15 will expand the surgeon’s flexibility and capability by offering a family of products in different length options with infinitely adjustable expansion and lordosis correction of upto 4mm and 15°.
Dale Binke, EOI’s VP of US Sales, notes that, “One of the major trends in fusion surgeries is progression towards MIS style procedures, inpatient or outpatient.” However, Dale explains, “There is an inherent challenge in inserting a large interbody cage that restores lumbar lordosis while controlling sagittal and coronal alignment.” He adds, “The FLXfit expandable cage is already providing the ultimate expandable TLIF solution, combining the best-in-class footprint that can be delivered through a MIS window and a unique expansion mechanism that restores lordosis.” Dale summarizes, “With the FLXfit15™, EOI’s engineering team has pushed the envelope a step further by combining an articulating cage with optimal footprint which can be easily delivered and expanded in a controlled manner up to 4mm and 15° of lordotic restoration.”
Expandable cages are gaining market momentum and play a key role in successful fusion procedures. Ofer Bokobza, CEO of Expanding Orthopedics, comments, “The FLXfit™ System has already trail blazed the way for anatomical fit, expandable cages by providing great clinical promise so far.” Ofer says, “The FLXfit15™ will further enhance the anatomical fit with its 15° lordosis and the shorter footprint version (32mm) will offer great flexibility in treating patients with smaller anatomies.” He concludes, “We are thrilled with the release of the FLXfit™15 in the US and certain that the enhanced versatility of the new FLXfit™ family will help gain a greater share in the fusion surgery market, both in MIS and open approaches.”
About Expanding Orthopedics Inc.
Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.
Contact info:
David Elkaim,
VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347)-3219683
SOURCE Expanding Orthopedics Inc.
