The US Food and Drug Administration (FDA) has approved additional indications for use of Anulex Technologies' fiXate tissue band product.
Previously fiXate tissue band 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 fiXate tissue band provides consistent SCS lead and intrathecal catheter anchor securement by providing a delivery system that facilitates efficient fixation to surrounding tissue in less than 30 seconds.
Anulex said, now the new indication allows for securing intrathecal pain pump catheters in the same tissue.
University of Washington Medical Center Center for Pain Relief Michael Gofeld said fiXate firmly secures the catheter anchor in the desired place.
Anulex chief executive officer Jeff Peters said additionally, implantation time and incision size is minimized in patients of all sizes.
"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," Peters added.