Antibacterial implant coatings and spine-related tech dominated digital traffic this past week.

The top pageview producer was Onkos Surgical, which won FDA de novo approval for its antibacterial-coated implants. To gain approval, the company presented the FDA with preclinical safety and efficacy data that showed the proprietary coating does not elute and is bactericidal, with a 99.999% (five log) kill rate in in-vitro testing of bacteria that are commonly found in the operating room. However, the technology’s effectiveness has not been shown in human clinical trials to prevent or reduce infection rates.  

Orthobond also drove ODT website traffic with its antibacterial technology. Like Onkos Surgical, the company gained FDA de novo approval for its antibacterial surface treatment on a permanent medical device. The company claimed the Ostaguard approval is the first de novo nod for a non-eluting coating to actively kill bacteria that contaminate a medical device’s surface. Orthobond’s method for covalently bonding its antibacterial molecule to implant surfaces is reportedly highly effective in killing multiple bacterial strains that could come in contact with an implant in the OR, while remaining safe for mammalian cells. The surface technology is applied during manufacturing before packaging and sterilization. Ostaguard’s initial application is in spinal implants. 

Spinal implants (possibly) like the TriALTIS spine system, the latest innovation from DePuy Synthes. Cleared by the FDA in October 2023, the next-gen posterior thoracolumbar pedicle screw system features an implant portfolio and instrumentation designed to be integrated with enabling technology, according to DePuy Synthes. Combined with navigation-enabled instruments, TriALTIS aims to address unmet clinical needs across degenerative, tumor, trauma and deformity pathologies in the spine. DePuy Synthes showcased the TriALTIS system this past week at the 31st International Meeting on Advanced Spine Techniques 2024.

Other pageview dynamos this second week in April inclluded the FDA clearance of Peleton Surgical’s single-use surgical power driver, and new executive appointments at Accelus. 

1. FDA Grants De Novo Approval to Onkos Surgical’s Antibacterial-Coated Implants

2. DePuy Synthes Releases TriALTIS Spine System

3. Orthobond’s Antibacterial Surface Treatment OK’ed for Spinal Devices

4. FDA Clears Peleton Surgical’s Single-Use Surgical Power Driver

5. Accelus Appoints New R&D and Product Management Leaders