Clinical Study Demonstrates Favorable Patient Outcomes with the FlareHawk® Expandable Cage

Adaptive Geometry™ facilitates compact delivery through minimal insertion exposure and an enlarged form within the disc space to promote fusion

PALM BEACH GARDENS, Fla., March 3, 2020 (GLOBE NEWSWIRE) – Integrity Implants Inc., a privately held medical device company dedicated to delivering innovative solutions for spine surgery, today announced positive data from a retrospective study demonstrating favorable fusion efficacy with its FlareHawk® interbody implant. The study, “Transforaminal/Posterior Lumbar Interbody Fusion with the FlareHawk Expandable Interbody Fusion Device,” was led by principal investigator Domagoj Coric, M.D., Chief of Neurosurgery at Carolinas Medical Center and Spine Division Chief of Atrium Musculoskeletal Institute, both in Charlotte, North Carolina.

Results from the multi-site study of 129 patients validate the safety and efficacy of the FlareHawk expandable fusion device. Among 58 subjects with radiographs at 12 ±3mo, nearly all (56 patients, or 96.6%) achieved fusion based on Bridwell-Lenke grading. Among 45 evaluable subjects, 71% (32 patients) achieved clinically significant improvements in VAS leg pain, and 76% (34 patients) achieved clinically significant improvements in VAS back pain. Additionally, there were no reported device-related adverse events (AEs). Common device-related AEs associated with interbody fusion devices include, but are not limited to, subsidence, displacement, and nerve injury. The incidence rate for non-device related AEs was 14.7%, which is consistent with other TLIF/PLIF studies.

Dr. Coric notes, “This study adds to the evidence base supporting the safe and effective use of expandable interbody spacers in the treatment of lumbar spine diseases. The FlareHawk implant’s ability to expand in both cephalad-caudal and lateral-medial planes is especially advantageous for decreasing neural retraction while maximizing vertebral body endplate coverage and fusion area.”

The FlareHawk spinal implant is the flagship product for Integrity Implants and represents the first of its kind in the expandable cage market. Much like coronary stents that offer patients a less-invasive alternative to open-heart procedures, the FlareHawk expandable cage features a PEEK shell that is inserted in a compressed form that can be effectively passed through small neural pathways and, once within the intervertebral disc space, expanded to a larger footprint and height. A titanium shim inserted within the PEEK shell produces the expansion and creates a solid-state construct that is resistant to collapse. The design accommodates the delivery of appropriate bone graft material into and through the apertures of the cage. The Adaptive Geometry™ philosophy embodied in the FlareHawk device emphasizes respect for patient anatomy through implant geometry that can be optimized for both insertion and long-term stability. To date, over 6,400 FlareHawk cages have been implanted in more than 4,300 patients.

Chris Walsh, Integrity Implants CEO, adds, “Importantly, this data set was achieved without the use of any biologics other than autogenous or allogenic bone graft, further validating our thesis that minimal nerve retraction and a large footprint are design imperatives that decrease the strain on a surgeon and facility to achieve a stable fusion. From the outset, we have heard anecdotally from our surgeon user group that the FlareHawk cage can be implanted with minimal or no nerve retraction and is a ‘fire and forget’ device, so we are thrilled, but not surprised, that the data set showed no device-related adverse events. With our TLIF and PLIF platforms complete, look for Integrity to expand our Adaptive Geometry platform into lateral, Kambin’s, and anterior approaches.”

Rohit Vasan, M.D., FAANS, Chief Medical Officer for Integrity Implants concludes, “Integrity Implants is dedicated to meet head-on the widely recognized, yet paradoxically unaddressed, challenges faced by spine surgeons in daily surgical operations. The company blueprint is simple: combine yesterday’s time-honored fundamental principles of surgery with tomorrow’s technology to offer solutions that are both minimally invasive and maximally effective today. For the surgeon obsessed with patient safety and clinical outcomes above all else, preferentially choosing products designed by this philosophy is as natural as always choosing to wash your hands before a procedure.”