The MIScoli system, a vertebral body tethering (VBT) device to treat scoliosis in young adolescents, has received Breakthrough Device Designation from the U.S. Food and Drug Administration, Spino Modulation Inc, a subsidiary of Montreal-based Spinologics, announces.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain medical devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions, including a prioritized review of market approval regulatory submissions.
VBT is a promising and lesser invasive alternative to spine fusion, the standard of care surgical intervention to correct a curvature of the spine. Fusion tends to be associated with long in hospital and at-home recovery times, growth and mobility restrictions, longer term pain and narcotics requirements, and significant surgical scars, the release explains.
Adolescent Idiopathic Scoliosis (AIS) is a common and underdiagnosed condition among adolescents. If detected, physical rehabilitation and braces are used to delay the progression of spine curvature. In the more severe cases, surgical intervention is needed.
Spine fusion is mostly recommended once the patient has finished growing. Therefore, teenagers must live with a worsening condition until early adulthood. VBT has the potential to disrupt treatment paradigms as it can be performed earlier in the patient’s history. A key mechanism to the success of this therapy is by leveraging the patient’s growing spine, known as growth modulation, per the release.
Spinologics was founded in 2010 by three orthopedics spine surgeons from Montreal (Canada) to create an environment where they develop surgical tools for back surgery.
Spino-Modulation focuses on the development of the MIScoli system, including sponsoring a pivotal clinical trial in Canada.
[Source(s): Spinologics, PR Newswire]
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