Biomet, a manufacturer of orthopedic and biotechnology products, has announced the first US implantation of its Comprehensive nano stemless shoulder as part of an US Food and Drug Administration investigational device exemption (IDE) multi-center prospective clinical study.
The Comprehensive nano stemless shoulder has been implanted in a study patient on 2 October 2013 by University of Virginia Medical Center’s, Charlottesville, Virginia, orthopedic surgeon Dr Stephen Brockmeier.
Dr Brockmeier said that he was impressed with the initial fixation of the stemless implant and was able to perform the shoulder replacement with minimal bone removal and components aligned with the patient’s natural anatomy.
Biomet has developed the Comprehensive nano stemless shoulder, which is a part of the company’s Comprehensive system, based on the clinical heritage of its T.E.S.S. stemless shoulder.
The T.E.S.S. stemless shoulder was launched in 2004 in the European and international markets.
Holy Cross Hospital in Fort Lauderdale orthopedic surgeon Dr Jonathan Levy, a participant in the clinical study, noted the procedure using the Comprehensive Nano allows him the potential to accurately restore shoulder anatomy without the limitations created by placing a stem within the humerus.
"The IDE study will allow us to objectively compare the efficacy of stemless and stemmed prostheses," Dr Levy added.
To address the increasing demand for less invasive treatments, Biomet has opened up short stem and stemless shoulder arthroplasty technology.