Relievant Medsystems enrolled the first patient in INTRACEPT, a Level I prospective randomized clinical trial comparing the Intracept® Procedure to conservative care to treat chronic low back pain.
Intracept Intraosseous Nerve Ablation uses radiofrequency energy to ablate basivertebral nerves, within the vertebral body. Once ablated, the nerves stop transmitting pain signals. The outpatient procedure lasts up to 90 minutes and can yield instant pain relief.
The study will enroll up to 150 patients at up to 20 U.S. centers. This is the second randomized controlled trial for the procedure, following SMART (Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain Trial), which supported the company's 3Q16 FDA 510(k) clearance. The new trial mimics certain aspects of SMART—such as patient inclusion/exclusion criteria, safety/efficacy enpoints—and will generate outcomes data to support reimbursement.
Source: Relievant MedSystems, Inc.