Spine technology company ulrich medical USA has received clearance from the US Food and Drug Administration (FDA) for expanded indications of its Momentum and Momentum MIS posterior spinal fixation systems.
This approval allows the systems to be used with G21 V-STEADY Radiopaque Bone Cement, enhancing treatment options for patients with advanced-stage spinal tumours.
ulrich medical USA Technology vice-president Eric Lucas said: “We are pleased to have received this expanded indication from the FDA.
“The combination of Momentum with V-STEADY offers our surgeon customers a new treatment option to support their most challenging patients.”
The Momentum systems are designed for stabilisation, fixation, and correction of the thoracolumbar and sacroiliac spine.
They support various adult degenerative and deformity cases, including occiput to pelvis connections, bone cement augmentation, and revisions for adjacent segment disease in spinal alignment restoration.
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By GlobalDataUCSF health orthopaedic spine surgery assistant professor Alekos Theologis said: “I’m excited that I can now use Momentum in conjunction with V-STEADY.
“Momentum has been a valuable treatment option and this enhancement will be beneficial to a segment of my patients.”
In October 2023, ulrich medical USA commercially introduced the Momentum MIS posterior spinal fixation system in the country.
This device was introduced earlier this year and the limited launch phase recently concluded successfully.
Momentum MIS offers a percutaneous solution to ulrich medical USA to meet the demand in the minimally invasive surgery market.
The company, a subsidiary of Germany-based ulrich medical, offers innovative spine technology and expandable corpectomy devices.