WARSAW, Ind.--(BUSINESS WIRE)--Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, announced today the first U.S. implantation of the Comprehensive® Nano Stemless Shoulder, part of an FDA Investigational Device Exemption (IDE) multi-center prospective clinical study.
The first Comprehensive® Nano IDE study patient was treated on October 2, 2013, 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 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.
About Biomet
Biomet, Inc. and its subsidiaries design, manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy. Biomet's product portfolio includes knee and hip reconstructive products; sports medicine, extremities and trauma products; spine, bone healing and microfixation products, including spine hardware, spinal stimulation devices, osteobiologics, and non-invasive bone growth stimulators; as well as neurosurgical and craniomaxillofacial reconstructive devices, and thoracic products; dental reconstructive products; and bone cement products, biologics, and other products. Headquartered in Warsaw, Indiana, Biomet and its subsidiaries currently distribute products in approximately 90 countries.
