Orthopaedic device giant Biomet, Inc., has trumpeted the first U.S. implantation of its Comprehensive® Nano Stemless Shoulder. The procedure was part of an FDA Investigational Device Exemption (IDE) multi-center prospective clinical study.
Biomet says it has pioneered short stem and stemless shoulder arthroplasty technology to address growing demand for less invasive treatments. The Comprehensive® Nano shoulder is part of the Comprehensive® System, a platform system offering unmatched options for the surgeon and patient, and the market-leading shoulder system in the United States.
The Comprehensive® Nano shoulder was developed based on the clinical heritage of the Biomet T.E.S.S. stemless shoulder, available in European and International markets since its launch in 2004.
The first patient was treated on October 2, 2013, by Stephen Brockmeier, MD, orthopedic surgeon at University of Virginia Medical Center in Charlottesville, Virginia.
Dr Brockmeier stated; “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.”
Source: Biomet, Inc., Business Wire