FDA approves Icotec pedicle screw system

Icotec AG received FDA approval for its Vader Pedicle System for use with or without bone cement augmentation, the company announced Nov. 10.

Advertisement

The Vader Pedicle System temporarily restores integrity to the spinal column without fusion for patients with advanced stage tumors in the thoracic or lumbar spine. The system is designed as a fusion alternative for patients who aren’t stable enough to undergo a fusion procedure.

Roger Stadler, Icotec CEO, said, “We are so proud to present today the Vader product family which represents our continued commitment to develop and commercialize spinal implants made from our radiotransparent, nonmetallic BlackArmor material that produces minimal image artifact while eliminating shielding and scattering of radiation during oncology treatments.”

It’s unclear when the company will start commercialization efforts.

More articles on healthcare:
10 recent ASC leadership moves
Virginia ASC takes infection prevention to new level — 3 insights
Surgery Partners goes all-in on cardiology — 5 quotes on its quarterly performance

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Register to Attend Webinar

160 ambulatory leaders just ranked the EHR as the single system most overdue for AI reinvention

Tuesday, August 11
12:00 PM - 1:00 PM CDT

Presenter: Gautam Shah, MBA, FACHDM, NextGen Healthcare

Advertisement

Next Up in Spinal Tech

Advertisement

Comments are closed.