The US Food and Drug Administration (FDA) has issued a first-in-world approval for a customized 3D-printed bone replacement. The Patient Specific Talus Spacer is designed to replace the talus bone, which sits at the top of the foot and forms part of the ankle joint, in patients with avascular necrosis (AVN) of the ankle.
Patients with ankle joint AVN number fewer than 8,000 yearly in the US, but the condition presents patients and their caregivers with dire options: when AVN degrades the talus, the ankle joint is unstable, making walking extremely painful or even impossible. Choices include ankle fusion, which eliminates motion of the joint and affects gait, or amputation of the leg below the knee.
“The implant provides a joint-sparing alternative to other surgical interventions commonly used in late-stage AVN that may disable motion of the ankle joint,” wrote FDA in announcing the approval of the talus spacer as a Humanitarian Use Device (HUD) through the agency’s humanitarian device exemption (HDE) process.
The pathway places strictures on any profits that Additive Orthopaedics, LLC, which received the approval, may make from the device. However, HUDs may get the nod if they show that they “will not expose patients to an unreasonable or significant risk of illness or injury,” rather than the “reasonable assurance of safety” standard set for premarket applications (PMAs). HDEs also are expressly exempt from a requirement to demonstrate effectiveness and need only demonstrate probable benefit.
The Patient Specific Talus Spacer was approved after FDA examined data showing results from 31 patients who had 32 talus replacement surgeries. After 3 years, patients showed, on average, a decrease in reported pain and an increase in average ankle joint range of motion.
FDA hits record for novel devices in 2020
The announcement comes just a day after FDA issued a report on its novel device activity in 2020.
A record 132 novel devices were authorized for use in 2020 by FDA’s Center for Devices and Radiological Health (CDRH). “Novel or innovative does not simply mean ‘new.’ They address an unmet need, or may be safer or more effective than currently available alternatives,” wrote CDRH director Jeffrey Shuren, MD, JD, in an FDA Voices piece detailing CDRH work with novel devices in 2020.
The prior yearly high for novel device clearances, approvals, and authorizations was 106, in 2018. Novel device authorizations have generally been climbing year-over-year over the past decade; FDA includes devices that come to market through several pathways in this tally; these include original premarket authorizations (PMAs), panel track supplement PMAs, de novo applications, humanitarian device exemptions, breakthrough 510(k)s, and specific emergency use authorizations.
“For FDA-approved and FDA-cleared medical devices, innovation, and safety are two sides of the same coin,” wrote Shuren.
Shuren highlighted some of 2020’s novel devices, which ran the gamut from surgical implants to diagnostic tests to a smart-phone based app.
The latter, dubbed EndeavorRx, is the first game-based digital therapeutic device designed to improve attention in children with attention deficit hyperactivity disorder (ADHD). (RELATED: First video game-based treatment gets go ahead from FDA, Regulatory Focus 15 June 2020).
FDA also authorized an implant to be used as an alternative to anterior cruciate ligament (ACL) reconstruction to treat tears of the knee’s ACL.
Several of the “firsts” came in a variety of novel in vitro diagnostic tests for COVID-19, including tests that involved sample pooling, point-of-care diagnostic and antibody tests and tests designed for home use. “These examples demonstrate the remarkable ability of the device ecosystem and the FDA to adapt and respond to emerging public health needs,” wrote Shuren.
FDA also launched its Digital Health Center of Excellence in 2020, and continues work through the Breakthrough Devices Program, added Shuren, noting that the latter program has now granted breakthrough designation to over 400 devices, with 23 having been approved, authorized or cleared by FDA. “Programs like these facilitate more rapid progress of innovative devices through the regulatory process,” he wrote.