WARSAW, Ind.–(BUSINESS
WIRE)–Biomet, Inc., a global leader in the manufacture of orthopaedic and
biotechnology products, today announced clearance of two new products by the
United States Food and Drug Administration (FDA): the E1® humeral bearing for
use with the Comprehensive® Reverse Shoulder System, and the Comprehensive® Segmental
Revision System.
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 Biomets 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.
1 Greene M., et al. Two Year RSA Evaluation of the Wear of
Vitamin E Stabilized Highly Cross-linked Polyethylene, the Stability of the
Regenerex Acetabular Shells, and Femoral Components with 32mm Heads. ORS 2011
Annual Meeting; Poster No. 1176.
2 Kurtz, S., et al. The UHMWPE Handbook: Ultra High
Molecular Weight Polyethylene in Total Joint Replacement (2nd ed.), Elsevier
Academic Press, San Diego, CA 2009.
3 Data on file at Biomet. Bench test results not necessarily
indicative of clinical performance.
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. Biomets product portfolio encompasses large joint
reconstructive products, including orthopaedic joint replacement devices, and
bone cements and accessories; sports medicine, extremities and trauma products,
including internal and external orthopaedic fixation devices; spine and bone
healing products, including spine hardware, spinal stimulation devices, and orthobiologics,
as well as electrical bone growth stimulators and softgoods and bracing; dental
reconstructive products; and other products, including microfixation products
and autologous therapies. Headquartered in Warsaw, Indiana,
Biomet and its subsidiaries currently distribute products in approximately 90
countries.
Posted by Sean Fenske, Editor-in-Chief, MDT
