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Table 1 Average Preoperative and Postoperative Outcome Scores, rTSA Patients with Augmented Baseplates SST Preop Augment Avg [+ or -] St Dev 4.
This success can be attributed to everyone involved in the clinical trial, especially the study investigators and coordinators; our R&D, regulatory and clinical teams; our partners and suppliers; and most importantly, the patients who participated in the landmark prospective, randomized study comparing Augment bone graft to autograft.
Fakih and Casper have used the Augment treatment in clinical practice since 2014, each focusing initially on poor prognostic women with histories of failed IVF cycles.
Augmented Posterior stabilized modular knee replacement prosthesis consisting of Femoral component size E/5 (asymmetric deep trochlear groove, with variable radii for condyles), titanium/cobalt chrome tibial component size E/5 (Highly polished top surface, modular with provision for attaching stem extension), crosslinked polyethylene modular articular insert, round polyethylene patellar component (three pegs); one medial tibial augment, one tibial extension stem with option of at least 4mm offset; USFDA APPROVED
Augment offers users the capability to simulate their products in 3D augmented reality at scale in real-time in real environments, all from the convenience of their smartphones or tablets.
Implant sizes and augment size use can be predetermined, and the decision can be made of whether or not an aTSA or rTSA would be a better option.
The company added that AUGMENT will be launched in international IVF clinics this year through an international programme called 'ACE' or AUGMENT Centers of Excellence.
For the small defect, the 3 mm step posterior augment glenoid conserves 25% more cancellous bone, 18% more cortical bone, and 23% more bone overall than that using eccentric reaming.
If the panel determines that the product's benefits outweigh any potential risks, the company expects approval of Augment by the FDA within three to six months after the panel date, BioMimetic said.
Augment is non-inferior to autograft in achieving the primary endpoint in the following three populations: (1) all 397 subjects (the randomized, treated, and eligible population) who were properly randomized and treated and met all of the screening and operative inclusion/exclusion criteria and were thus eligible to participate in the study (61.
The following presentations highlighted the clinical and pharmaco-economic need and biologic rationale for Augment Bone Graft as an alternative to autograft.
BioMimetic received regulatory approval in 2009 and 2011 to market Augment in Canada, and in Australia for hindfoot and ankle fusion indications.