30 Day Trial

Study Results: Benvenue Medical, DiscGenics, Stryker

Share:

Clinical studies of Benvenue Medical's Luna™ interbody fusion device in minimally invasive Transforaminal Lumbar Interbody Fusion (TLIF) showed improved patient outcomes and decreased back and leg pain at 12 months post-op. Biomechanically, Luna performed better in reducing intervertebral motion than the Anterior Lumbar Interbody Fusion (ALIF) control cage, per results of a separate independent analysis of the data.

Single center data from 47 consecutive MIS TLIF patients showed lordosis was maintained or improved equally with the Luna lordotic and parallel cages, and back and leg pain were equally relieved for both cages, with a fusion rate of 95%. Findings suggest that the larger footprint of the Luna cage plus preservation of the anterior soft tissue tension band may lead to better biomechanical fusion.

Luna is a multi-expandable interbody fusion device that combines ALIF principles with a posterior approach designed to provide anterior column stability, strength and fusion support. (Source: Benvenue Medical, Inc.)

 

Preclinical study results demonstrated that intradiscal injection of Discogenic Cells, the active ingredient in DiscGenics' IDCT allogeneic cell therapy, may be a viable treatment for degenerative disc disease. The cells produce an extracellular matrix that may rebuild depleting tissue within the discs. 

Earlier this month, DiscGenics announced that the first 30 subjects have been safely treated in its first-in-human 60-patient U.S. clinical study of IDCT. An independent data safety monitoring committee reported no safety issues, and recommended that the trial continue with no changes to the protocol. (Sources: DiscGenics, Inc.; ORTHOWORLD)

 

Results from the SAKOS pivotal trial of Stryker's SpineJack® implantable fracture reduction system successfully demonstrated non-inferiority to balloon kyphoplasty (BKP), with an excellent risk/benefit profile for up to 12 months.

SAKOS was a prospective, multicenter, randomized study designed to support a non-inferiority finding for use of SpineJack vs. BKP to treat vertebral compression fractures. This trial also provided compelling evidence to establish superiority of SpineJack vs. BKP in the absence of adjacent level fractures and restoration of midline vertebral body height at 12 months.

Over 70,000 SpineJack units have been implanted in patients worldwide. (Source: Stryker)

Stryker SpineJack System - ORTHOWORLD
Stryker's SpineJack Fracture Reduction System