The new 7mm insertion profile, combined with the company’s proprietary Adaptive Geometry™ technology, aims to respect the patient’s nerves, blood vessels, bones and soft tissue anatomy during and after insertion to promote long-term stability
Palm Beach Gardens, Florida, August 17, 2021 (Global News Agency) — Accelus, a private medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of spinal care, today announced the launch of FlareHawk7, a multi-directional The expandable lumbar fusion device is inserted with a 7 mm ultra-low profile to help minimize nerve retraction before the cranio-caudal and medial-lateral planes are expanded to provide sagittal and coronal corrections and intervertebral foramina height restoration And stability promotes integration.
The FlareHawk7 platform is also equipped with a set of instruments designed to promote surgeons’ technical preferences. For endoscopic TLIF surgery, the surgeon can access with instruments to allow direct visualization of disc preparation and implant delivery. For MIS surgery, the surgeon can enter the intervertebral disc space through the Kambin triangle, while still preserving the patient's normal anatomy. In the "mini-open" procedure, the insertion footprint is smaller and similar to the outline of the No. 2 pencil, so the need for nerve traction can be minimized.
"FlareHawk7 enables me to perform complete endoscopic interbody fusion in outpatient surgery, with the best endplate preparation and excellent clinical results," said the world-renowned leader in endoscopic spine surgery, MD and PhD.
FlareHawk7 allows simultaneous expansion of height and width to restore the height of the disc without sacrificing stability. It enters the intervertebral disc space in a compact profile of 7 mm x 7 mm, and then expands to 11 mm x 12 mm-57% increase in width and 72% increase in height-with 0° and 6° lordosis options. This provides a larger surface contact area to distribute the load, with the goal of reducing the sinking of fragile osteoporotic bones. The open structure design of the implant also allows a large number of grafts to be delivered to the surrounding intervertebral disc space through the implant.
"FlareHawk7 is a game changer," said Jason Huffman, a recognized leader in the field of minimally invasive spinal fusion and director of the Hoffman Clinic in Napa, California. "It allows me to quickly and effectively perform thorough discectomy and interbody fusion kick butt, multi-planar expandable, structured cage, and at the same time use a minimally invasive, percutaneous method to pass the Kambin triangle."
Dr. Paul Houle, MD, a board-certified neurosurgeon at Cape Cod Healthcare Neurosurgery in Hyannis, Massachusetts, agrees. "Historically, when patients have scars, my surgical options are very limited," said Dr. Houle. "However, FlareHawk's narrow insertion profile means that I can treat these patients backwards from a single position-which is currently not available in other products on the market."
The first in its class FlareHawk® series of implants uses a PEEK shell and internal gasket to provide a small insertion profile to minimize nerve retraction during insertion, and then allow height, width, and lordosis expansion, designed to Reduce sinking, restore the height of the intervertebral foramen and re-establish sagittal balance. Peer-reviewed studies have shown that FlareHawk’s adaptive geometry is a potential contributor to the positive fusion rate of implants, as well as the unobserved sinking 1-4. This is a problem for the overall cage, that is, the inter-implant The elastic modulus does not match the bone. To date, more than 10,500 FlareHawk cages have been implanted in more than 9,000 patients.
"No other implant can represent our Adaptive Geometry and Access Without Compromise™ philosophy, and the ultra-low 7mm insertion profile of FlareHawk7 extends to 11mm, which is exactly 2mm wider than the average 9mm TLIF implant. This allows for less nerve retraction than the device, but takes up more space," said Chris Walsh, CEO of Accelus. "We reject dogma in our approach because FlareHawk7 supports endoscopic, percutaneous, micro-opening, and dual-implant open PLIF procedures-all of which benefit from Accelus' Access without Compromise promise."
About FlareHawk Expandable Lumbar Intervertebral Fusion System
FlareHawk interbody fusion system is suitable for spinal interbody fusion of autologous bone grafts and/or allogeneic bone grafts composed of cancellous bone and/or cortical cancellous bone, in patients with degenerative disc disease (DDD) Of skeletal mature individuals, from L2 to one or two consecutive levels S1, after discectomy. DDD is defined as discogenic back pain, and disc degeneration is confirmed by medical history and radiological studies. These patients should receive at least six (6) months of non-surgical treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or posterior spondylolisthesis at the level involved. FlareHawk system gaskets are designed to be used with supplemental fixation devices, which have been approved for use in the lumbar spine.
Accelus is committed to accelerating minimally invasive spinal surgery through its surgical support technology, which can broadly enter previously underserved markets. Founded in 2021, the company, through the combination of Integrity Implants and Fusion Robotics, focuses on providing practical and economical navigation and robotics solutions for its proprietary adaptive geometry technology, which has a wide range of clinical uses in spinal surgery.
The photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/06410131-d598-4c8c-a4fb-ef00c23db9ce
Media Contact: Brandy Craig 305-676-1679 bcraig@accelusinc.com
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