Accelus, a privately held medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, today announced the first spinal surgeries with the FlareHawk® TiHawk11™ Interbody Fusion System (TiHawk11). TiHawk11 is designed to provide a minimal insertion profile with maximum interbody expansion to increase stability and the likelihood of fusion.

The first TiHawk11 procedure was performed by Dr. Kalman D. Blumberg, a fellowship-trained orthopaedic spine surgeon at Florida Spine Specialists, in Fort Lauderdale, Fla. in May 2022, and since then more than 150 TiHawk11 devices have been implanted to date.

“The titanium-bonded TiHawk11 continues the solid performance of all the Accelus interbody devices produced so far,” Dr. Blumberg said. “This latest version allows a minimal insertion profile compared to its expanded size, which is especially useful for my revision cases requiring a tight dissection. I have found the performance of TiHawk11 to be unparalleled.”

TiHawk11 is part of Accelus’s flagship FlareHawk Interbody Fusion System and features an 11mm-wide insertion profile that expands to 17mm in width and up to 14mm in height within the disc space. This provides surgeons with a 70% increase in footprint as compared to a 10mm-wide interbody device of identical length and allows for two 17mm-wide TiHawk implants to be implanted via a posterior approach to create a 34mm-wide footprint within the disc space.

“Utilizing the TiHawk11 device allows me to maximize expansion in both the medial/lateral and cephalad/caudal planes,” said Dr. Frank P. Cammisa, spine surgeon at Hospital for Special Surgery in New York City. “Its biplanar expansion helps me significantly lower the risk of subsidence, and its ability to conform to the patient’s endplates while allowing for substantial post-packing of graft provides structural support that ultimately increases the chance for fusion.”

TiHawk11 features all the advantages of FlareHawk, now bonded with titanium. TiHawk’s titanium surface technology provides a 0.5 micron-thick layer of commercially pure titanium bonded onto the PEEK through a proprietary process called ion beam assisted deposition. This thin layer of titanium does not alter the favorable properties found with PEEK implants nor does it generate a ghost artifact under fluoroscopic imaging as is common with all-titanium implants, allowing ease of radiographic visualization for TiHawk11 implant placement and fusion assessment.

“We are excited about the key features, advantages and benefits that TiHawk11 brings to surgeons and the results we have seen from these first surgeries,” said Chris Walsh, Accelus CEO and Co-Founder. “Historically the spine market has chased larger footprint implants through adaptive trajectory. Footprint has given rise to interbody approaches such as LLIF, OLIF and ALIF that offer a surgeon the ability to insert larger-footprint implants. However, Accelus’s Adaptive Geometry™ creates medial-lateral and caudal-cranial expansion functionality. Subsequently, many of our surgeon customers are adapting a posterior approach to many of their fusion cases as all the FlareHawk implants allow the surgeon to directly decompress the nerve root without a compromise in footprint or nerve health, what we term Access without Compromise.”

Source: Company Press Release