Carlsmed, Inc., today announced it has been granted 510(k) clearance and Breakthrough Device Designation by the FDA for its aprevo patient specific interbody devices for the correction of adult spinal deformity. The Carlsmed aprevo device is the first implant ever to receive both Breakthrough Device Designation and 510(k) market clearance from the FDA.
To meet the designation criteria, FDA has determined that aprevo provides for more effective treatment of an irreversibly debilitating condition than the current standard of care.
Carlsmed’s aprevo is also the only spinal device to qualify for the Alternative Inpatient New Technology Add-On Payment (NTAP) Pathway for Transformative New Devices that was enacted by the Centers for Medicare & Medicaid Services (CMS) beginning with NTAP applications for FY 2021. Upon authorization of the NTAP, which is currently under review by CMS for FY 2022 approval, hospitals will receive an add-on payment from CMS of up to 65% of the cost of the device.
“Today’s announcement is great for patients, surgeons, and providers, with a major step forward towards true personalization of surgical correction for spinal disorders,” said Mike Cordonnier, CEO of Carlsmed. “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.”
In the U.S. alone, it is estimated that more than 6 million adults have mild to severe spinal deformity. Each year, more than 1.6 million patients seek surgical or non-surgical treatment for this debilitating condition. Shay Bess, MD, world-renowned orthopedic spine surgeon at Denver International Spine Center and advisor to Carlsmed commented, “For many patients, surgical treatment has been shown to significantly reduce disability and pain and to improve quality of life. This outcome is best achieved by obtaining the optimal correction for each patient while also reducing complications and minimizing the need for revision surgery. Carlsmed’s aprevo is poised to help align outcomes with surgeon and patient expectations.”
“Emerging technologies like aprevo are vital for improving healthcare efficiencies and patient satisfaction,” said Jenell Paul-Robinson, MSN, RN; formerly the Director of the Value Analysis Program at UCLA Health, and previously 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.”
Carlsmed is leveraging Machine Learning technologies and prior outcomes data to personalize the treatment of complex adult spinal deformities. The Company’s proprietary aprevo solution makes surgical plans and devices tailored to the precise medical situation of each patient. Our mission is to transform healthcare by finally giving spine surgeons the tools to obtain better results at a lower cost of treatment while helping adults regain their active lifestyles.