Cresco Spine Receives Breakthrough Device Designation for Scoliosis System

Cresco Spine’s Spring Distraction System, which is intended to treat early onset scoliosis, has received an FDA Breakthrough Device designation.

Early onset scoliosis is a spine deformity that is presents before 10 years of age — scoliosis generally presents around age 13 — that often includes deficient cardiopulmonary development. In early onset of the condition, treatments are often associated with high complication rates, multiple surgeries, and high economic burdens on the young patient group and their guardians, Cresco said.

The Spring Distraction System is meant to allow for 3D guided spinal growth, even in extreme deformations, minimizing the number of operations. According to the company, the system is currently being tested on “a significant number of patients” in clinical exemption trials and is seeing successful results.

The FDA Breakthrough Device Designation was created in 2015 to expedite access to medical devices that treat life-threatening and debilitating conditions and diseases for which no other approved or cleared alternatives exist or that offer significant advantages over available alternatives.

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