Carlsmed today said it received FDA 510(k) clearance and breakthrough device designation for its Aprevo patient-specific interbody devices to correct adult spinal deformity.
Aprevo is a spinal device that is designed to provide more effective treatment of an irreversibly debilitating condition than current standards of care, according to the company.
“Today’s announcement is great for patients, surgeons, and providers, with a major step forward towards true personalization of surgical correction for spinal disorders,” CEO Mike Cordonnier said in a news release. “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.”
The devices provide personalized correction using planning tools and personalized implants based on a patient’s pathology.
“Emerging technologies like Aprevo are vital for improving healthcare efficiencies and patient satisfaction,” said Jenell Paul-Robinson, former director of the value analysis program at UCLA Health, and previous VP of clinical value and provider relations at MedTech Innovator. “Solutions like Aprevo bring significant efficiencies to the healthcare industry. Early adopter surgeons and hospitals will be positioning themselves as true trailblazers for this type of personalization in spine surgery.”