A single-use, plastic instrument for spinal surgery has proved its mettle in a comparative strength study performed by the Orthopaedic Trauma Institute at the University of California San Francisco (UCSF). The disposable lumbar device developed by Xenco Medical (San Diego, CA) showed "no visible fracture" at 40 mm of cantilever deflection, whereas "the aluminum instrument exhibited significant deformation," noted the UCSF report.
One component in the company's line of disposable cervical and lumbar spinal systems, the first-of-its-kind device is made of a reinforced composite polymer that withstood a continuously applied load of 25 mm/min. The material's strength and the fact that it eliminates any chance of infection because it is a single-use device are an illustration of the company's manifesto of "disruptive innovation for the purposes of creating a safer surgical environment."
"The composite polymer used in Xenco Medical's devices is paramount to the company's disruption of the spine industry," CEO Jason Haider told PlasticsToday. Surgeons traditionally have had no option but to use "antiquated metal instruments" that may be improperly sterilized, said Haider. "Unlike steel surgical systems that are used repeatedly in hundreds of patients, Xenco Medical's surgical systems ensure every patient is operated on with single-use instruments functioning at their peak condition. The single-use nature of Xenco Medical's products also allows hospitals and ambulatory surgery centers to stock hundreds of Xenco Medical's spinal systems, all of which could be used for emergency cases that would otherwise require late-night delivery of medical equipment to the facility," added Haider.
The strength of the devices is derived from the unique nature of the interfacial bond in the reinforced, composite polymer, explained Haider. "Making use of the crystallinity of polyamides, which allows for less internal tension, and the strength of various compounds, including glass fiber, Xenco Medical engineers all of its surgical instruments from a highly durable fibrous matrix. Capable of withstanding very high loads of force at every contact point, every instrument by Xenco Medical is developed through a dialogue between material science and mechanical design. Because spine surgery requires power at variable angles, Xenco Medical's engineering process employs heuristic searches to optimize every point of the instrument," Haider told PlasticsToday.
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Medical technology companies increasingly must balance improved patient outcomes with costs if they are going to be successful in the marketplace. Haider believes that his company's disruptive approach fully achieves that goal. Referencing a paper published in the Journal of the American Medical Association Surgery (JAMA Surgery) titled, "Costs Associated with Surgical Site Infections in Veterans Hospitals," Haider notes that surgical site infections (SSIs) are associated with significant excess costs. "Among the highest-volume specialties, the greatest mean cost attributable to SSIs was $23,755 among patients undergoing neurosurgery," said the article. Single-use devices represent a real remedy to this epidemic, as hospital-acquired infections have been called. "Xenco Medical's composite-polymer surgical systems have been welcomed across the country because of the safety and savings they provide," said Haider because they "eliminate the costs associated with the autoclave process, the delivery and retrieval process, surgery postponement due to sterilization errors and extended care due to infections."
Xenco Medical, which was first adopted for use by the UCLA Spine Center on July 13, 2015, has expanded its distribution to five states since then.
Chalk this up as another victory for plastics in the medical arena. Last month, we reported on a device for transcatheter aortic valve replacement surgery developed by Direct Flow Medical, which reportedly achieved a significant improvement in patient safety by replacing all of the metal parts with plastic components.