Fuse Medical Launches Orbitum Compression Staple System

Fuse Medical Inc. has launched the Fuse Orbitum Compression Staple, a product designed for the foot or hand that is significantly different than legacy bone staple fixation solutions.

The company also announced the first Orbitum implantations in Georgia and Texas. The staple is the latest addition to Fuse’s portfolio of internal fixation devices for upper and lower extremities.

“We are excited to bring to market a new way to provide compression in small bone fracture management, with a streamlined insertion technique,” Fuse CEO Christopher C. Reeg said. “While there are many staples on the market, we believe the Orbitum Staple System offers a compression mechanism relying on physics, rather than the elasticity of memory metal alloys. Combining a unique compression mechanism with a robust, plate-like construct has proven to be beneficial for anatomies requiring the strength of a traditional plate, without the additional complications of proper alignment of a two-legged staple, or a plate/screw construct.”
 
The patented Orbitum Staple System consists of the Orbitum VI and Orbitum X Staples—products that differ considerably from the current industry standard of staple leg compression. The titanium alloy Orbitum implant has multiple narrow legs arranged in a radius around a central bridge; the design consists of multiple tines beveled to diverge upon implantation and generate bone compression. The Orbitum VI can be used similarly to a traditional staple or a plate and screw construct. The Orbitum X round staple provides circumferential compression and can be used for three or four corner fusions with a single implant.
 
Leslie Richey-Smith was one of the first surgeons to implant the Orbitum Compression Staple. Considering the foot’s high loads and small bone architecture, Richey-Smith chose the Orbitum VI hourglass staple because its design offers the compression of a staple and strength of a plate. “This staple is incredible. It just reduced my surgical time by more than half!” demonstrating the system’s ease of use and implantation,” Richey-Smith said. 
 
Robert Weinstein of Atlanta used the Orbitum Staple for a tarso-metatarsal fusion. “The Orbitum Staple is an elegant, technically straightforward implant that eliminated the difficulty often encountered with isolated central tarso-metatarsal fusion. The rapid insertion sequence and ease of placement of the Orbitum Staple could not be more appreciated, as fixation is a common pain point of this operation. When I employ current bone staples in fusions and osteotomies, I consistently see gapping of the far cortex. This can be attributed to leg convergence which seems to induce a deleterious stress in the interface,” he said. “Since the objective is to compress bone ends symmetrically, top to bottom, the Orbitum Staple System solves this problem, and fundamentally changes the way bone staples should be designed.”
 
Orbitum is inserted into decorticated or softer bone using a punch tool, though a traditional drill template and drill bit is still needed for stronger bone mineral density. Orbitum gives the surgeon flexibility when implanting devices into different parts of the body, and it heps substantially reduce OR time by minimizing or eliminating the need for power instrumentation while minimizing removal of critical bone material essential for friction seating.
 
Orbitum’s templating system allows surgeons to visually confirm size and orientation before placing the implant, resulting in better sizing and staple leg insertion angle accuracy. The Orbitum implant leg geometry also has pull out resistance that is five times greater than comparable staples, according to data on file.
 
“As we continue to add products to our portfolio, our priority at Fuse remains, to provide effective solutions for today’s clinical challenges, and assist with improving surgical outcomes,” Reeg concluded.