Exactech (NSDQ:EXAC) said yesterday it launched its Opterak revision knee system and that the system has been successfully implanted in its 1st set of patients.
The revision knee system is composed of proprietary net compression molded polyethylene and is indicated for use in skeletally mature patients undergoing surgery for total knee replacements due to osteoarthritis, osteonecrosis, rheumatoid arthritis and post-traumatic degenerative problems, as well as to revise previously failed reconstructions, Exactech said.
“I was honored and pleased to be the 1st to use the new instruments and devices for revision of a failed knee replacement. The implant provided excellent early stability and kinematics, and allowed my patient to be discharged to home within 2 days. The instruments were intuitive, comfortable to use and allowed for a straightforward and accurate approach to assessing bone loss, and for re-establishing proper implant position, alignment and stability. This was a satisfying experience that I believe many surgeons will be able to share, as this innovative new implant and instrument system helps them to address the myriad of problems encountered in revision total knee replacement,” Dr. Bernard Stulberg of St. Vincent Charity Medical Center in Cleveland, Ohio said in a press release.
The pilot launch of the revision knee system will continue through 2015, with full market availability in the U.S. slated for 2016.
“We are reaffirming our commitment to revision arthroplasty. It is our goal to deliver patient-driven solutions that allow surgeons to provide a wide continuum of care. Clinical use of this knee system is the culmination of years of collaboration with world-renowned revision total knee surgery experts,” CEO David Petty said in prepared remarks.
The Gainesville, Fla.-based company said it is also pilot-launching a revision hip stem and shoulder humeral reconstruction prosthesis.
In June, Exactech said it won FDA 510(k) clearance for its Optetrak Logic constrained condylar prosthesis for revision knee arthroplasty patients.
The post Exactech launches Opterak revision knee system appeared first on MassDevice.
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