GRAND RAPIDS, Mich., Could 8, 2023 /PRNewswire/ — HAPPE Backbone, a medical machine firm targeted on bringing revolutionary supplies to orthopaedic implants, pronounces that the corporate’s INTEGRATE-C™ Interbody Fusion System has acquired 510k clearance from the FDA.
Powered by the HAPPE® platform, INTEGRATE-C™ is the primary interbody fusion cage that’s totally built-in with porosity and hydroxyapatite to offer a superior therapeutic surroundings. The interconnected, cancellous porosity promotes bone ingrowth from endplate-to-endplate. Hydroxyapatite is uncovered on all surfaces to advertise cell signaling and bone on-growth. The INTEGRATE-C™ is each radiolucent and radiovisible for superior intra-operative and post-operative imaging.
Andrew Iott, CEO of HAPPE Backbone stated, “We’re very excited to have gained 510K clearance for HAPPE’s new revolutionary know-how and sit up for launching game-changing product options within the close to future. The mixture of cancellous porosity with hydroxyapatite uncovered on all pore surfaces represents a real leap ahead in interbody fusion units.”
Dr. Stephen Smith, MD, Neurosurgeon on the Beacon Health System and a co-inventor of the HAPPE know-how stated, “Our staff at HAPPE is proud and excited to share this development with our colleagues. We’ve got achieved our objective of creating an ACDF that’s distinguished from all different current units used for interbody fusion. The HAPPE INTEGRATE-C™ delivers superior radiographic visibility, optimum biomechanical properties for each load bearing and therapeutic, and true graft incorporation.”
Dr. Daniel Riew, MD, Professor of Orthopedics and a number one skilled in cervical spine surgical procedure stated, “I sit up for using HAPPE’s revolutionary product, which has all of the radiographic and scientific advantages of an artificial cage whereas overcoming the damaging features of an inert, hydrophobic PEEK machine that can’t osteointegrate.”
The INTEGRATE-C™ system gives a mess of sizes and lordotic angles to accommodate affected person anatomy. The corporate’s commercialization technique is presently targeted on a restricted consumer launch to ascertain efficacy with scientific information.
About HAPPE Backbone:
HAPPE Backbone was based by Dr. Ryan Okay. Roeder, a Professor on the College of Notre Dame and CTO of the corporate. HAPPE Backbone LLC is a medical machine improvement firm that designs and commercializes revolutionary orthopedic and spinal implants using the patented Hydroxyapatite Porous Polyetheretherketone (HAPPE®) materials platform. HAPPE transforms polyetheretherketone from a hydrophobic, inert, and non-integrating materials right into a hydrophilic, floor energetic, and osteointegrating materials, confirmed by strong bone in-growth and on-growth in preclinical testing. In vitro efficiency or animal research will not be consultant of scientific efficiency. The HAPPE INTEGRATE-C™ interbody fusion system is the primary to supply bone-like cancellous porosity with uncovered hydroxyapatite on the pore surfaces, in addition to porosity extending throughout your complete implant peak to advertise endplate-to-endplate osteointegration. INTEGRATE-C™ is designed to advertise each load bearing and therapeutic, in addition to superior post-operative imaging. The HAPPE INTEGRATE-C™ interbody fusion system thus gives allograft-like qualities in an artificial implant which will enhance scientific outcomes in interbody spinal fusion by overcoming the issues of pseudoarthrosis, subsidence and imaging artifacts that restrict present PEEK and titanium implants.
Be taught extra about HAPPE Backbone and HAPPE® materials platform at happeortho.com.
SOURCE HAPPE Backbone