FDA Clears Conventus PH Cage™, MIS Proximal Humerus Fracture Solution

Conventus Orthopaedics has received FDA clearance of the PH Cage™ , the first expandable cage for the surgical repair of shoulder fractures.

Background

If you’ve never heard of Conventus Orthopaedics (me neither), the company was named after the Latin word for “coming together” or “union.” As such its sole purpose is to develop its platform technology with less invasive solutions to a broad range of challenging peri-articular fractures.

Patients needing surgical treatment for multipart fractures of the shoulder’s proximal humerus have hitherto 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.

Made of nitinol, the Conventus Cage™ 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. The design prioritizes 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.

Conventus says it plans a measured U.S. market introduction in the coming weeks. The news of the PH cage’s clearance comes on the back of the recent announcement that Conventus had raised $24million with which it intended to accelerate product commercialization and invest in new research and development.

Physician comments

“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.”

Company comments

“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.”

Source: Businesswire

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