Breakthrough Designation for MIScoli Vertebral Body Tethering

By Julie A. Vetalice

Breakthrough Designation for MIScoli Vertebral Body Tethering

Spino Modulation, a subsidiary of Spinologics, received FDA's Breakthrough Device Designation for its MIScoli™ system, an innovative vertebral body tethering (VBT) device to treat scoliosis in young adolescents.

MIScoli is one of a few VBT devices that are under investigation, or limited market release, in many countries. Various medical device developers have committed to developing VBT solutions to serve an unmet need in the scoliosis surgical treatment market.

VBT is an alternative to spine fusion, today's standard of care when adolescents need a surgical intervention to correct a curvature of the spine. Patients, and their parents, are looking for treatment options that are less traumatic than fusion, which is associated with long in hospital and at-home recovery times, growth and mobility restrictions, longer term pain and narcotics requirements and significant surgical scars.

Source: Spinologics

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory