Conventus Orthopaedics Receives FDA Clearance for PH Cage™, Proximal Humerus Implant Device
MINNEAPOLIS–(BUSINESS WIRE)–With the recent FDA clearance of the Conventus PH Cage™ for the surgical repair of shoulder fractures, patients and their surgeons can soon benefit from the industry’s first expandable fracture cage.
The Conventus Cage™, made of nitinol, a nickel titanium alloy, expands within the bone creating robust fixation and preventing further collapse of the fracture. 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.
Until now, patients needing 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, Conventus Orthopaedics CEO. “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 measured U.S. market introduction in the coming weeks.
Conventus designed and developed the proprietary device in close consultation with an expert 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 Dr. Andrew Schmidt, Chief of Trauma, Hennepin County Medical Center. “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.”
