MAPLE GROVE, Minn., Aug. 15, 2016 /PRNewswire/ — Conventus Orthopaedics, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new Conventus Cage™ DU (Distal Ulna) and PU (Proximal Ulna) Systems, designed as innovative solutions to address fracture repairs of the ulnar bone. These new implants, the fourth and fifth approved indications for the company, continue Conventus’ momentum in providing solutions for fracture fixation throughout the body based on a self-expanding scaffold.
Utilizing the shape memory properties of nitinol, the Conventus CageTM expands within the bone creating robust, stable fixation and thus prevents collapse of the fracture repair. Similar to the company’s first three products, and aligned with the company’s principles of 3-dimensional design, these new Conventus Cages™ create rigid substrates designed to self-expand within the bone to avoid interference with soft tissues. The self-expanding scaffolds provide options to achieve reliable and less invasive repairs while potentially eliminating the need for a second surgery when compared with alternative options.
Paul Buckman, Conventus President and CEO said, “The approval of this additional indication reflects our commitment to provide more innovative solutions and options for surgeons working to repair orthopedic fractures throughout the body. Our overall goal is to provide a complete platform technology enabling surgeons to treat all trauma and fracture repairs from a 3-dimensional approach.”
Paul Paterson, M.D. of Excelsior Orthopaedics, Buffalo, NY said, “Plate fixation of the distal ulna is not an easy fix due to the size of the bone. The Conventus Cage DU offers tremendous stability of the fracture—better than plates and screws—and decreased recovery time due to the minimally invasive technique.” Andrew Palmer, M.D. added, “There is a definite benefit to the Conventus devices that are implanted into the bone. It eliminates the potential for interference of plates, screws or tension band wiring as well as the need for a second surgery to remove fixation.”
Conventus’ 3-dimensional Cage platform technology, emphasizes 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 continues to expand their product portfolio and surgical applications in their quest to provide solutions throughout the entire musculoskeletal system.
The Conventus Cage™ DU and PU are for treatment of distal and proximal ulna fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device. For more information regarding use of the device please refer to www.conventusortho.com.
About Conventus Orthopaedics, Inc.
Conventus Orthopaedics, Inc. was founded by a team of medical device professionals and physicians with the sole purpose of improving patient care by creating a platform technology with less invasive solutions to a broad range of challenging peri-articular fractures. Taking its name from the Latin word for coming together or union, Conventus Orthopaedics is focused on creating less invasive solutions for fractures in and around the joints. The company is dedicated to working with surgeons to improve healing and enable their patients’ return to normal activities.
SOURCE Conventus Orthopaedics, Inc.