RICHARDSON, Texas--(BUSINESS WIRE)--Fuse Medical, Inc. (OTCPINK: FZMD) (“Fuse” or the “Company”) an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace, announced the initial launch and first implantations of the Fuse Orbitum™ Compression Staple. This is the latest addition to Fuse’s comprehensive orthopedic portfolio of internal fixation devices for upper and lower extremities.
The patented Orbitum™ Staple System, consisting of the Orbitum™ VI and Orbitum™ X Staples, indicated for use in the foot or hand, is a significant departure from legacy bone staple fixation. The industry’s current designs revolve around staple leg compression, yet the actual need is to achieve full bone compression. The design of the titanium alloy Orbitum™ implant is novel in shape and function, with multiple narrow legs arranged in a radius around a central bridge. This unique geometry consists of multiple tines beveled to diverge upon implantation and generate bone compression. The Orbitum™ VI is designed for use in applications similar to a traditional staple or a plate and screw construct. The Orbitum™ X round staple provides circumferential compression and can be utilized for three or four corner fusions with a single implant.
Leslie Richey-Smith, DPM, Corinth, TX, was the first to implant the Orbitum™ Compression Staple in the calcaneocuboid. Due to the high loads and small bone architecture in the foot, Dr. Richey-Smith opted for the Orbitum™ VI hourglass staple because of its unique design offering the compression of a staple and strength of a plate. Upon final implantation of the device, Dr Richey-Smith stated, “This staple is incredible. It just reduced my surgical time by more than half!” demonstrating the system’s ease of use and implantation.
“We are excited to bring to market an innovative new way to provide compression in small bone fracture management, with a streamlined insertion technique,” commented Christopher C. Reeg, Chief Executive Officer of Fuse. “While there are many staples on the market, we believe that the Orbitum™ Staple System offers an innovative 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.”
Robert Weinstein, DPM, FACFAS, Atlanta, GA, the first surgeon to implant the Orbitum™ Staple for a tarso-metatarsal fusion, stated “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. 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. This system is a true game changer.”
Orbitum™ employs a unique method for insertion into decorticated or softer bone using a punch tool, while retaining a traditional drill template and drill bit for stronger bone mineral density. This gives the surgeon flexibility when implanting into different regions of the body, which substantially reduces operative 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 the surgeon to visually confirm size and orientation prior to the actual placement of the implant, demonstrating higher accuracy of sizing and staple leg insertion angles to further enhance the implant's efficiency and surgical outcome. Moreover, the Orbitum™ implant leg geometry promotes superior pull out resistance five times greater than comparable staples.*
Reeg further added, “As we continue to add innovative products to our comprehensive portfolio, our priority at Fuse remains, to provide effective solutions for today’s clinical challenges, and assist with improving surgical outcomes.”
About Fuse Medical, Inc.
Fuse is an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace. We provide a comprehensive portfolio of products in the orthopedic total joints, sports medicine, trauma, and extremity space, as well as, degenerative and deformity spine, osteobiologics, wound care, and regenerative products.
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Forward Looking Statements
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