Integrity Implants Receives CE Mark for FlareHawk Expandable Lumbar Interbody Fusion Device

By Julie A. Vetalice

Integrity Implants Receives CE Mark for FlareHawk Expandable Lumbar Interbody Fusion Device

Integrity Implants received CE mark certification for its FlareHawk Expandable Lumbar Interbody Fusion Device. FlareHawk launched in the United States in 2016 and more than 8,500 FlareHawk devices have been implanted in more than 6,000 patients to date.

The uniqueness of the FlareHawk multidirectional interbody fusion cage called for a different approach than that used by many medical device manufacturers to demonstrate equivalence to other previously approved products. Instead, Integrity Implants compiled original retrospective clinical evidence data on FlareHawk’s performance and safety, including fusion rates, patient-reported outcome scores and adverse events.

The data utilized in the study followed strict inclusion criteria and was drawn from participants with comorbidities often seen in the general patient population, including high BMI, diabetes, coronary heart disease, hypertension and a history of smoking. The study also only allowed allograft or autograft to help facilitate fusion as opposed to more expensive spinal biologics like BMP, DBM or other processed biologics. Among the 129 study patients, TLIF (51%) or PLIF (49%) surgery was performed on 171 levels. A minimally invasive approach was used in 88% of the cases.

Outcomes were impressive, with 97.4% of levels achieving fusion based on the well-respected Bridwell-Lenke grading classification. Additionally, there were no (0%) reported device-related adverse events, no (0%) observations of cage subsidence (defined as an overlap between the vertebral endplates and the device exceeding 25% of the device height), and only one case (1.7%) of observed device migration (defined as displacement of the device relative to the position within intra-operative or immediate post-operative images). More than 70% of patients also demonstrated clinically significant improvements in VAS leg and back pain scores.

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.

Source: Integrity Implants

Product Labels: Spinal Fusion

Tags: CE Mark, Regulatory