Acuity Surgical Units, LLC has obtained regulatory clearance from the FDA by means of a particular 510(ok) software for his or her additively manufactured spinal interbody gadget portfolio with HAnano Floor, increasing the number of spinal units in medical use with HAnano Floor.
GOTHENBURG, SWEDEN AND DALLS (PRWEB) OCTOBER 13, 2022 –
Promimic AB, the world’s main innovator in nano floor therapies for improved osseointegration, is happy to announce a particular 510(ok) clearance from the U.S. Food and Drug Administration (FDA) for Acuity Surgical Units, LLC. That is the second particular 510(ok) FDA clearance of a medical gadget with HAnano Floor, validating that the regulatory pathway is permitting an expedited clearance course of.
The Align portfolio contains additively manufactured titanium units meant for the next approaches: stand-alone Anterior Lumbar Interbody Fusion (ALIF), Indirect Lumbar Interbody Fusion (OLIF), and Lateral Lumbar Interbody Fusion (LLIF). Every Align gadget options an enhanced porous construction designed to enhance adhesion to the vertebral physique endplates. With this particular 510(ok) clearance, Align implants additionally combine the super-hydrophilic HAnano Floor that has been proven to advertise sooner and stronger osseointegration in pre-clinical research with roughened titanium implants.
“We’re delighted that Acuity Surgical Units selected our hydrophilic HAnano Floor to additional differentiate their product portfolio. That the clearance got here after an expedited particular 510(ok) additional establishes a sooner path to marketplace for our clients, in order that extra implants with improved osseointegration can be utilized clinically”, says Magnus Larsson, Promimic CEO.
“We’re very excited to reinforce our choices inside within the Align product household. This collaboration is an instance of how Acuity listens to its surgeon companions and continues to put money into complete spine options to match surgeon wants with affected person advantages. We imagine the bioactive efficiency of the nano floor supplementing our enhanced porous construction will make Align implants with HAnano Floor the brand new gold commonplace in stability”, says John Davidson, President of Acuity Surgical Units.
HAnano Floor has been evaluated in additional than thirty pre-clinical research, testing quite a lot of implant supplies and designs in numerous fashions. It has confirmed to extend anchoring power for titanium implants by as much as 35% in simply three weeks. The research additionally present that HAnano Floor up-regulates necessary bone marker proteins and improves new bone formation on titanium implant floor by 67% at 4 weeks.*
For extra details about HAnano Floor, please go to https://www.promimic.com/. To be taught extra about Acuity Surgical Units Align portfolio, please go to https://www.acuitysurgical.com/.
*Knowledge on file at Promimic AB.
Promimic is a progress firm that develops and markets biomaterials for improved osseointegration to main firms within the fields of dental and orthopedic implants. The principle product HAnano Floor has been developed from innovative analysis at Chalmers College of Know-how in Sweden. The expertise is confirmed to enhance osseointegration in over thirty scientific research and with over 700,000 implants in medical use. Promimic has places of work in Mölndal, Sweden and Austin, Texas, USA.
Backbone surgeons select Acuity Surgical Units for spinal implant options. They know they’ll depend on Acuity’s unwavering dedication to world class buyer assist of its premier lumbar, cervical, and biologic evidenced-based programs.
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HAnano Floor is a registered trademark of Promimic AB, Mölndal, Sweden.
Align is a registered trademark of Acuity Surgical Units, LLC, Dallas, Texas, USA.