Vy Spine, a leader in spine innovation leveraging advanced materials and designs, has achieved U.S. Food and Drug Administration (FDA) clearance for its LumiVy OsteoVy PEKK Lumbar Interbody Fusion (IBF) device. This innovative implant is designed for intervertebral body fusion at one or two contiguous levels in the lumbar spine, specifically from L2 to S1, for patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis.<\/p>\n\n\n\n
The LumiVy OsteoVy PEKK Lumbar IBF uniquely combines the osseointegration benefits of the 3D printed OXPEKK material with Vy Spine’s proprietary OsteoVy lattice structure. Available in multiple footprints and heights from 6mm to 21mm, this device addresses a wide range of lumbar interbody approaches, including anterior, oblique anterior, lateral, posterior, and transforaminal. Additionally, the LumiVy system features IBF-S implants with self-drilling screws for enhanced stability directly to the bone.<\/p>\n\n\n\n
“The clearance of the LumiVy OsteoVy PEKK Lumbar IBF exemplifies Vy Spine’s commitment to harnessing our proprietary designs,” said Bret Berry, President of Product Development at Vy Spine. “Our research into OXPEKK has revealed its remarkable properties, surpassing traditional PEEK materials.” Scott DeFelice, CEO of Oxford Performance Materials, noted, \u201cThis milestone reflects the powerful synergy between OPM’s cutting-edge 3D printing technology and Vy Spine\u2019s expertise in spine solutions, positioning us for significant market adoption.\u201d<\/p>","protected":false},"excerpt":{"rendered":"
A Vy Spine anuncia a autoriza\u00e7\u00e3o da FDA para a sua LumiVy OsteoVy PEKK Lumbar IBF, uma solu\u00e7\u00e3o avan\u00e7ada impressa em 3D para a fus\u00e3o inter-corpos lombar, melhorando os resultados dos doentes no tratamento da doen\u00e7a degenerativa do disco.<\/p>","protected":false},"author":2,"featured_media":31571,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"colormag_page_layout":"default_layout","footnotes":""},"categories":[7,711,25],"tags":[687,763],"class_list":["post-31570","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-americas","category-orthopaedics","category-products-technologies","tag-fda","tag-spine"],"_links":{"self":[{"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/posts\/31570","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/comments?post=31570"}],"version-history":[{"count":1,"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/posts\/31570\/revisions"}],"predecessor-version":[{"id":31572,"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/posts\/31570\/revisions\/31572"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/media\/31571"}],"wp:attachment":[{"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/media?parent=31570"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/categories?post=31570"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pt\/wp-json\/wp\/v2\/tags?post=31570"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}