The FDA has awarded Carlsmed's aprevo device its breakthrough device designation, which will expedite the time it takes to reach clinical trials.
The device is the only spine technology to receive the FDA's breakthrough device designation and is now available for use.
"Obtaining breakthrough designation means the FDA believes that aprevo could improve the standard of care and wants to provide patients with more timely access to this technology," CEO Mike Cordonnier said in a Dec. 8 news release.
Aprevo is a patient-specific interbody for the treatment of adult spinal deformity, and the first Carlsmed device to receive FDA clearance and breakthrough device designation.
Aprevo also qualified for CMS' alternative inpatient new technology add-on payment track for "transformative new devices," beginning with NTAP applications for fiscal year 2021.
CMS is reviewing the device for its NTAP application for fiscal year 2022. If approved, hospitals will receive additional CMS payment of up to 65 percent of the cost of aprevo.