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."
Analysis shows gender and racial disparities in pulmonary embolism treatment