MINNETONKA, Minn.--(BUSINESS WIRE)--Anulex Technologies, Inc., a privately held medical device manufacturer, announced today that the U.S. Food and Drug Administration (FDA) has cleared additional indications for use of its fiXate™ Tissue Band product. The fiXate Tissue Band previously received clearance for securing Spinal Cord Stimulation (SCS) lead anchors to fascia or interspinous/supraspinous ligaments in patients with chronic, intractable pain of the trunk and/or limbs. The new indication allows for securing intrathecal pain pump catheters in the same tissue.
The Anulex Technologies fiXate™ Tissue Band provides more consistent SCS lead and intrathecal catheter anchor securement by offering a novel delivery system that facilitates efficient fixation to surrounding tissue in less than 30 seconds. By utilizing an in-line design, fiXate facilitates a smaller incision to allow less invasive surgery.
After trying fiXate™ Tissue Bands for securing intrathecal catheter and spinal cord stimulation leads, Dr. Michael Gofeld from the Center for Pain Relief at University of Washington Medical Center had this to say: “fiXate firmly secures the catheter anchor in the desired place. Additionally, implantation time and incision size is minimized in patients of all sizes.” Jeff Peters, Anulex’s Chief Executive Officer, goes on to say, “with the expansion of indications for fiXate Tissue Band, Anulex continues to demonstrate its commitment to developing novel and clinically relevant solutions for soft tissue fixation and repair.”
About Anulex Technologies, Inc.
Anulex Technologies,
Inc. is dedicated to the development and commercialization of unique and
proprietary soft tissue repair and fixation products. This latest
clearance builds on our existing product platform which includes the
XcloseTM Plus Tissue Repair System and the VersacloseTM
Tissue Repair System which utilize proprietary InvisilocTM
Technology enabling surgeons to easily re-approximate soft tissue to
facilitate the healing process. More information on the Company can be
found at www.anulex.com.
fiXate, Xclose, Versaclose and Anulex are trademarks of Anulex Technologies, Inc.