Benvenue Medical, a developer of minimally invasive solutions for spine repair, today announced U.S. commercial launch of the Luna® 3D Interbody Fusion System in conjunction with the North American Spine Society (NASS) Annual Meeting.
At the meeting, Benvenue Medical will also accept the 2015 Spine Technology Award for Luna in the Minimally Invasive Spine and Thoracolumbar Care categories.
Luna 3D’s full-scale launch follows a successful limited rollout, in which more than 100 patient levels were treated via both minimally invasive and open TLIF approaches. Luna 3D was cleared by the FDA in November 2014 and represents the next generation of expandable interbody fusion devices.
"Luna 3D is a significant improvement over other available static and expandable TLIF cages," said Michael Wang, MD, chief of neurosurgery at University of Miami Health System. "Due to the implant’s cannula delivery, implantation is possible through a narrow surgical corridor, resulting in minimal nerve root retraction and tissue dissection."
Luna 3D is a new expandable interbody designed for minimally invasive surgery (MIS), mini-open or open posterior approaches. Luna 3D’s controlled, atraumatic insertion through a 6-8 mm cannula is designed to minimize nerve retraction and mitigate implant migration.
In-situ 3D expansion provides zero-impaction delivery, intended to preserve and protect vertebral endplates. Once in the disc space, Luna 3D expands to 25 mm in diameter and up to 13 mm in height. Bone graft is inserted into the Luna 3D cage after expansion, thereby optimizing this critical aspect of fusion surgery.
"The launch of Luna 3D and its recognition as a spine technology of the year further solidifies Benvenue Medical as an innovative company focused on minimally invasive spine," said Robert K. Weigle, CEO of Benvenue Medical, Inc. "Our portfolio features award-winning, proprietary expandable technology that is well-positioned for spine surgeons’ clinical requirements while serving the unmet needs of the open and MIS spinal implant markets."
In addition to Luna, Benvenue offers the Kiva VCF treatment system, which was recently awarded a 2015 Medical Design Excellence Gold Award in the Implant and Tissue-Replacement Products category.
Kiva is a circular implant for spinal fractures, proven in a randomized, controlled study published in Spine to restore kyphotic angle and reduce the rate of adjacent level fractures vs. balloon kyphoplasty – with added economic benefits. It uses expandable spinal implant technology to create a predictable structure.