Patient-specific implants, which tout more accurate spine and orthopedic surgery, have made several advances in 2021. Reception among surgeons remains mixed, however.
Here are seven industry observations and opinions from surgeons:
1. Medtronic's patient-specific UNiD Rods were cleared for use with the devicemaker's CD Horizon, Solera, Voyager and Infinity OCT spinal systems, which comprise rod, hooks, screws and interbody fusion devices, in June.
2. Custom spine implants are making inroads with CMS. Carlsbad's implant, Aprevo, received two reimbursement boosts in October: transitional pass-through payment and the new technology add-on payment. These nods came shortly after Post Falls, Idaho-based Northwest Specialty Hospital became the first specialty hospital in the U.S. to use the device.
3. The FDA approved the first patient-specific talus spacer in the U.S. as a humanitarian use in February. The 3D-printed implant is the first of its kind to be approved for use in the country and is used to treat avascular necrosis of the talus.
4. Hospital for Special Surgery is making strides in custom joint replacement technology. In March, the New York City-based hospital teamed with devicemaker Lima to open a 3D-printing facility for joint replacements. The ProMade Point of Care Center at HSS' main campus creates implants for more complex cases to meet the needs of each patient's anatomy.
5. Data released in March validated the cost-effectiveness of patient-specific total knee implants. An independent review of surgeon data between 2016 and 2019 show that Conformis' iTotal knee replacement implants lead to expedited surgical time and shorter hospital stays. Months later, the second-generation version of the iTotal implant was debuted in the outpatient setting at Coastal Virginia Surgery Center in Newport News, Va.
6. Spine surgeon Vijay Yanamadala, MD, told Becker's he sees more companies and surgeons utilizing custom implants.
"Right now, we see Medicrea with Medtronic creating patient-specific rods that allow us to achieve the lordosis we want," he said. "A lot of this came out of work that the Scoliosis Research Society has done. We spend hours planning surgery, but oftentimes — particularly in complex spine surgery, multilevel fusions, spinal deformity surgery for scoliosis, revision surgery — we realize in 30 to 40 percent of cases we may not achieve our alignment goals. We measure parameters like pelvic incidence and lumbar lordosis and try to match those. There are lots of software packages that allow us to plan surgery."
7. Orthopedic surgeon Andrew Bush, MD, said he was skeptical of patient-specific joint implants.
"Having performed several hundred robotic assisted joint replacement surgeries, I am of the opinion that robotic assisted surgery is the future of joint replacement surgery," he told Becker's. "A patient will be best served at our current level of technological development by having a well-designed generic implant that is made from the appropriate materials and is appropriately sized during the robotic procedure, implanted with automated precision that is based on the dynamic force measurements intraoperatively obtained by the computer-driven robotic system."
Cory Calendine, MD, is optimistic that orthopedic implants will improve, but said he isn't convinced they're the "final frontier."
"Speaking specifically of hip and knee replacement, every surgery must be customized and unique to that single patient," he said. "The implant is one part of this equation, but a patient's soft tissue is the other. To place a custom implant without accommodating the patient's soft tissue is to err. The challenge is: How do we reveal the patient's soft tissue needs prior to surgery? Or do we develop a way to fabricate a custom implant on site, during surgery?"