Biomet, Inc., a provider of orthopedic and biotechnology products, has announced the first U.S. implantation of the Comprehensive Nano Stemless Shoulder, part of an FDA Investigational Device Exemption (IDE) multi-center prospective clinical study.
In a release, Biomet noted:
The first Comprehensive Nano IDE study patient was treated on October 2, by Stephen Brockmeier, MD, orthopedic surgeon at University of Virginia Medical Center in Charlottesville, Virginia. "We are excited to be a part of the clinical trial evaluating this potentially significant evolution in shoulder arthroplasty. I 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," Dr. Brockmeier said.
"I am excited to be a part of the team investigating the Comprehensive Nano," said Jonathan Levy, MD, of Holy Cross Hospital in Fort Lauderdale, Florida, a participant in the clinical study. "The procedure using the Comprehensive Nano allows me 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."
Biomet said the Comprehensive Nano shoulder is part of the Comprehensive System, a platform system offering unmatched options for the surgeon and patient.
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