Biomet получило регистрацию FDA на два новых продукта:
E1® Humeral Bearing для системы Comprehensive® Reverse Shoulder
и систему Comprehensive® Segmental Revision
Biomet, Inc., мировой лидер в сфере ортопедии и биотехнологии, сегодня обявил о регистрации двух своих систем в United States Food and Drug Administration (FDA), это: E1® humeral bearing для использования совместно с Comprehensive® Reverse Shoulder System, а также Comprehensive® Segmental Revision System.
"Этот продукт специально разработан для решения проблем дефицита костной ткани при ревизионных и онкологических вмешательствах."
The E1® humeral bearing with exclusive Antioxidant-Infused Technology is the first Vitamin E advanced bearing option for reverse shoulder applications. Biomet first applied the clinically successful1 E1® technology to its hip and knee products. The integration of E1® technology into the Comprehensive® Reverse Shoulder portfolio will provide surgeons and patients with an advanced bearing surface with oxidative stability, high strength and low wear.2,3
"Biomet is the first company to bring advanced bearing surfaces to the shoulder," said John Sperling, MD, orthopaedic surgeon, Rochester, Minnesota. "The outstanding wear characteristics and proven track record of E1® bearings will provide a tremendous benefit to patients undergoing reverse shoulder arthroplasty."
The FDA also cleared Biomet's Comprehensive® Segmental Revision System (SRS), a humeral replacement system designed to address significant bone loss, both proximally and distally. The Comprehensive® SRS offers oncologic options, soft tissue attachments, and multiple sizing options, and is compatible with the Comprehensive® Shoulder system and the Discovery® Elbow system.
"The Comprehensive® SRS is a breakthrough in shoulder and elbow arthroplasty design," said Dr. Sperling. "This system is specifically designed to address humeral bone deficiency in revision and oncologic settings."
"This system is particularly helpful for surgeons specializing in revision shoulder or elbow surgery where modularity and intra-operative flexibility is critical," said Quin Throckmorton, MD, orthopaedic surgeon, Memphis, Tennessee.
"Этот продукт специально разработан для решения проблем дефицита костной ткани при ревизионных и онкологических вмешательствах."
The E1® humeral bearing with exclusive Antioxidant-Infused Technology is the first Vitamin E advanced bearing option for reverse shoulder applications. Biomet first applied the clinically successful1 E1® technology to its hip and knee products. The integration of E1® technology into the Comprehensive® Reverse Shoulder portfolio will provide surgeons and patients with an advanced bearing surface with oxidative stability, high strength and low wear.2,3
"Biomet is the first company to bring advanced bearing surfaces to the shoulder," said John Sperling, MD, orthopaedic surgeon, Rochester, Minnesota. "The outstanding wear characteristics and proven track record of E1® bearings will provide a tremendous benefit to patients undergoing reverse shoulder arthroplasty."
The FDA also cleared Biomet's Comprehensive® Segmental Revision System (SRS), a humeral replacement system designed to address significant bone loss, both proximally and distally. The Comprehensive® SRS offers oncologic options, soft tissue attachments, and multiple sizing options, and is compatible with the Comprehensive® Shoulder system and the Discovery® Elbow system.
"The Comprehensive® SRS is a breakthrough in shoulder and elbow arthroplasty design," said Dr. Sperling. "This system is specifically designed to address humeral bone deficiency in revision and oncologic settings."
"This system is particularly helpful for surgeons specializing in revision shoulder or elbow surgery where modularity and intra-operative flexibility is critical," said Quin Throckmorton, MD, orthopaedic surgeon, Memphis, Tennessee.
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