02.04.22
AxioMed submitted its lumbar viscoelastic total disc replacement PMA Module II to the FDA on January 28, 2022.
“The demand for disc replacement has been compounding over years in the USA, Europe and Australia and will J curve with the FDA approval of the superior AxioMed lumbar viscoelastic disc at the same time that we see more insurance coverage of disc replacement and patient awareness of the pitfalls of spinal fusions versus greater benefits of total disc replacements,” says chief technology officer and Harvard-trained orthopedic spine surgeon professor Kingsley R Chin MD, MBA.
Harvard-trained orthopedic spine surgeon Dr. Erik Spayde and Dr. William Costigan, MBA are two leading board-certified orthopedic spine surgeons who see their practices immediately moving towards more outpatient lumbar surgeries using the AxioMed viscoelastic lumbar disc replacement.
“With FDA approval of the AxioMed anterior lumbar disc, and to follow next with a lateral lumbar disc would allow me to perform my own access above L5-S1, so my fusion cases for degenerated intervertebral disc disease would soon be replaced by the AxioMed disc,” comments Dr. Spayde.
“We are grateful for the consistency demonstrated by our team to execute on the completion of each module to meet our targeted FDA submission dates,” says Vito Lore, VP of Innovation for the KICVentures Group.
There is increasing demand for cervical disc replacements among spine surgeons and patients to treat degenerative disc disease. AxioMed anticipates similar demand to follow with introduction of the AxioMed lumbar disc replacement and more positive insurance reimbursement. The amount of lumbar spinal fusions is increasing but we expect reimbursement and margins to decrease with bundling and price contraction from competition and commoditization.
“We are already working on the third and final module to submit by April to complete the full FDA submission,” says John Sullivan, VP of Global Quality Affairs and Regulatory Compliance for the KICVentures Group.
USA surgeons can soon join surgeons in Australia, Europe and the Caribbean who have used the cervical and lumbar discs in spine surgery clinically.
The AxioMed viscoelastic disc replacement’s properties allow for a single-piece design with 4-12 degrees of lordosis and acts identical to the normal human disc to restore disc height and provide for shock absorption. The competition are ball and socket designs based on copying knee replacements so there are multiple pieces moving against surfaces with NO shock absorption property. Published clinical studies are showing incidences of implant dislocation, heterotopic bone formation and microscopic wear debris production which causes bone osteolysis, all complications similar to what we saw with their hip and knee joint replacement cousins.
“The demand for disc replacement has been compounding over years in the USA, Europe and Australia and will J curve with the FDA approval of the superior AxioMed lumbar viscoelastic disc at the same time that we see more insurance coverage of disc replacement and patient awareness of the pitfalls of spinal fusions versus greater benefits of total disc replacements,” says chief technology officer and Harvard-trained orthopedic spine surgeon professor Kingsley R Chin MD, MBA.
Harvard-trained orthopedic spine surgeon Dr. Erik Spayde and Dr. William Costigan, MBA are two leading board-certified orthopedic spine surgeons who see their practices immediately moving towards more outpatient lumbar surgeries using the AxioMed viscoelastic lumbar disc replacement.
“With FDA approval of the AxioMed anterior lumbar disc, and to follow next with a lateral lumbar disc would allow me to perform my own access above L5-S1, so my fusion cases for degenerated intervertebral disc disease would soon be replaced by the AxioMed disc,” comments Dr. Spayde.
“We are grateful for the consistency demonstrated by our team to execute on the completion of each module to meet our targeted FDA submission dates,” says Vito Lore, VP of Innovation for the KICVentures Group.
There is increasing demand for cervical disc replacements among spine surgeons and patients to treat degenerative disc disease. AxioMed anticipates similar demand to follow with introduction of the AxioMed lumbar disc replacement and more positive insurance reimbursement. The amount of lumbar spinal fusions is increasing but we expect reimbursement and margins to decrease with bundling and price contraction from competition and commoditization.
“We are already working on the third and final module to submit by April to complete the full FDA submission,” says John Sullivan, VP of Global Quality Affairs and Regulatory Compliance for the KICVentures Group.
USA surgeons can soon join surgeons in Australia, Europe and the Caribbean who have used the cervical and lumbar discs in spine surgery clinically.
The AxioMed viscoelastic disc replacement’s properties allow for a single-piece design with 4-12 degrees of lordosis and acts identical to the normal human disc to restore disc height and provide for shock absorption. The competition are ball and socket designs based on copying knee replacements so there are multiple pieces moving against surfaces with NO shock absorption property. Published clinical studies are showing incidences of implant dislocation, heterotopic bone formation and microscopic wear debris production which causes bone osteolysis, all complications similar to what we saw with their hip and knee joint replacement cousins.