Centinel Spine (New York) has completed the initial cases with three different implant portfolios within its FLX platform of integrated interbody and non-integrated interbody fusion devices.
FLX devices are 3D-printed, all-titanium implants with a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility, as compared to solid titanium implants. The devices also have a proprietary “fuse-thru” trabecular scaffold designed to allow for bony in-growth and on-growth throughout the implant. Centinel Spine received FDA-clearance for multiple cervical and lumbar interbody fusion device families in May of this year.
Centinel’s Stalif C and Stalif M FLX integrated interbody devices are indicated for use at one or two contiguous levels with both autograft and/or allogenic bone graft, unlike other all-titanium implants, according to a company statement. Centinel also makes Stalif devices from PEEK and titanium-surfaced PEEK.
“The FLX implant offers an open bone graft window optimizing graft volume and allowing bone growth throughout the trabecular matrix structure,” said Dr. Stelios Koutsoumbelis, chief of orthopedic surgery at South Nassau Communities Hospital, in the statement.
Koutsoumbelis performed the first Actilif C FLX cervical interbody implantation. “The open configuration also allows for CT visualization post-operatively to assess fusion,” he said.
The initial implantations of the FLX products represent a significant milestone in the evolution of Centinel’s interbody technologies and advanced material platforms, according to company chairman & CEO, John Viscogliosi.
“Our FLX products merge the proven benefits of the Stalif design with a truly novel, all-titanium lattice technology,” Viscogliosi said. “This provides surgeons the flexibility to use multiple implant material options through a single set of instruments to address each patient’s unique pathology.”
Centinel is currently developing stand-alone, no-profile, integrated interbody fusion technology. It raised $132,250,000 in the first quarter of 2018.