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Company officials are calling the device an industry first.
Minneapolis, Minn.-based Conventus Orthopaedics Inc. received U.S. Food and Drug Administration clearance for its PH Cage for the surgical repair of shoulder fractures. The company is calling it the industry’s first expandable fracture cage. The cage is made of nitinol, a nickel titanium alloy, and expands within the bone creating robust fixation and preventing further collapse of the fracture, according to the company. Similar to the company’s first product for the wrist, the new PH Cage creates a rigid internal scaffold upon completion of the implant procedure. Traditionally, patients who need surgical treatment for multipart fractures of the shoulder’s proximal humerus have been limited to traditional fixation technologies or, in some cases, left to consider shoulder replacement alternatives. Because of the shoulder’s unique forces and range of motion, physicians have long sought a new and less invasive surgical approach over current technologies. “For years, shoulder surgeons have expressed the need for more versatile surgical options to repair simple to complex proximal humeral fractures,” said Paul Buckman, CEO of Conventus Orthopaedics. “The Conventus PH Cage will expand what is possible in patient care by enabling surgeons to repair a wider variety of proximal humeral fractures through less invasive means. We believe this is another important building block in our technology platform and has the potential to transform the repair of shoulder fractures.” The company plans a U.S. market introduction in the coming weeks. Conventus designed and developed the device in consultation with a group of surgeon advisors. The design is aligned with the principles of the Conventus platform technology, which emphasize preservation of tissues and blood supply at the fracture site, creating a strong foundation by stabilizing bone fragments and facilitating early motion through less invasive procedures. “The PH Cage provides intramedullary fragment support and flexible fixation within the proximal humerus. These features help solve the problems that have been shown to compromise the outcomes with traditional techniques of open reduction and internal fixation as well as hemi-arthroplasty procedures for complex proximal humeral fractures,” said Andrew Schmidt, M.D., chief of trauma at Hennepin County Medical Center in Minneapolis. “This versatile implant provides robust fixation and facilitates surgeons’ needs to confidently proceed with a challenging repair, knowing they can even stabilize osteoporotic bone fragments. The unique characteristics of the PH cage should lead to fewer complications due to fracture collapse and better outcomes; results that can be demonstrated as we begin to build clinical experience.”
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