FDA Clears Expanded Indications For Anulex’s fiXate™ Tissue Band

“fiXate firmly secures the catheter anchor in the desired place. Additionally, implantation time and incision size is minimized in patients of all sizes.”

In short

US soft tissue and repair company Anulex Technologies, Inc., has announced that the U.S. FDA has now cleared its fiXate™ Tissue Band product for securing intrathecal pain pump catheters to fascia or interspinous/supraspinous ligaments in patients with chronic, intractable pain of the trunk and/or limbs.

The product’s previous indication limited it to securing Spinal Cord Stimulation (SCS) lead anchors.

Background

According to the company, its 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. It claims that by utilising an in-line design, fiXate facilitates a smaller incision to allow less invasive surgery.

Clinician comments

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.”

Company comments

Jeff Peters, Anulex’s Chief Executive Officer, said “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.”

Regulatory status in Europe

The fiXate™ system is not yet CE marked and the company is not planning a foray into Europe at the present time.

Source: Anulex Technologies, Inc.