Empirical Spine
Empirical Spine is dedicated to providing innovative, minimally invasive, motion-preserving solutions for spinal conditions such as degenerative spondylolisthesis and lumbar spinal stenosis. Their flagship product, the LimiFlex™ Dynamic Sagittal Tether, offers an alternative to traditional spinal fusion, aiming to restore natural motion and stability while reducing surgical invasiveness and associated risks.
Industries
Nr. of Employees
small (1-50)
Products
Dynamic sagittal tether implant (motion-preserving posterior tension band)
An implantable device intended to augment the posterior tension band after lumbar decompression to provide elastic resistance to flexion, maintain lordosis, encourage facet engagement, and preserve segmental motion as an alternative to rigid fusion for selected patients.
Dynamic sagittal tether implant (motion-preserving posterior tension band)
An implantable device intended to augment the posterior tension band after lumbar decompression to provide elastic resistance to flexion, maintain lordosis, encourage facet engagement, and preserve segmental motion as an alternative to rigid fusion for selected patients.
Services
Pivotal IDE clinical trial execution
Management and enrollment of a pivotal IDE clinical study for a motion-preserving posterior tension-band spinal implant; includes investigational-arm management and data presentation.
Regulatory submission support (PMA)
Preparation and submission of PMA documentation and interaction with regulatory authorities for implantable spinal devices.
Pivotal IDE clinical trial execution
Management and enrollment of a pivotal IDE clinical study for a motion-preserving posterior tension-band spinal implant; includes investigational-arm management and data presentation.
Regulatory submission support (PMA)
Preparation and submission of PMA documentation and interaction with regulatory authorities for implantable spinal devices.
Expertise Areas
- Motion-preserving spinal implant development
- Minimally invasive spine surgery
- Pivotal IDE clinical trial management
- FDA PMA regulatory strategy and Breakthrough Device interactions
Key Technologies
- Dynamic tension-band implant mechanics
- Motion-preserving spinal implants
- Minimally invasive posterior implantation techniques
- Posterior tension-band augmentation