01 Jul Integrity Implants Inc. receives CE mark certification for flagship FlareHawk Expandable Lumbar Interbody Fusion Device
Ortho Consulting Group (OCG) have welcomed the news that Integrity Implants Inc., the leader in Adaptive Geometry™ technology for innovative spine surgery solutions, has received CE mark certification for its flagship FlareHawk Expandable Lumbar Interbody Fusion Device.
FlareHawk launched in the United States in August 2016 and more than 10,500 FlareHawk devices have been implanted in more than 8,500 patients to date.
In addition to receiving FDA clearance and CE mark approval, FlareHawk has also received approvals in Argentina, New Zealand, Taiwan and the United Arab Emirates. Spine surgeons in the European Union Economic Area (EEA) will soon be able to access FlareHawk’s minimal insertion profile, multiplanar and endplate-conforming expansion, and maximum graft delivery.
OCG were appointed to help drive Integrity Implants Inc.’s expansion in 2020, by strengthening their global sales channels with a focus on opening European markets.
“This milestone is a huge success for José and the team at Integrity Implants” said OCG founder Matt Woods. “As companies, we share similar values, and we are excited to be part of this project. Integrity Implants Inc. are an established industry leader that are building game-changing products for the industry”
“We look forward to continuing to bring our experience engaging distribution partners across Europe, and to the continued success of Flarehawk.”
The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
“Integrity Implants achieved a significant milestone in earning the CE Marking for this novel technology, and is thrilled to have partnered with Ortho Consulting Group in finding and recruiting several of Europe’s finest distributors in the UK, Spain, Germany, Portugal, Italy, and Greece,” said Jose Calleja, Integrity Implants Inc. Executive Vice-President, International.
“Ortho Consulting Group’s expertise in finding top-tier partners for orthopaedic companies has been invaluable not only in finding the top talent but rather in determining the allies that best fit our needs. Together, we will bring this game-changing product to deserving patients and surgeons in the United Kingdom and the European Union.
“I look forward to a long and fruitful relationship with Matt, Andrew, and the entire OCG team.”