Benvenue Medical Announces Commercial Availability of Luna® 3D Interbody Fusion System, 2015 Spine Technology Award

CHICAGO–(BUSINESS WIRE)–Benvenue Medical, Inc., 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.

“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’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.

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“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.

To learn more about Luna 3D and Kiva, visit Benvenue Medical during NASS at booth 829.

About Spinal Fusion

Spinal fusion is a procedure that fuses, or joins, two or more vertebrae to treat low back pain from degenerated discs. One of the most common causes of low back pain, degenerated discs often cause symptoms of pain and can result in radiating pain, weakness or numbness in the legs. Fusion is designed to eliminate motion in that fused segment of the spine, thereby decreasing or eliminating the back pain. Recent advances in surgical technology and techniques have allowed fusion to be performed in a less invasive manner, with reduced incision size, tissue dissection, bone removal, and blood loss. This Minimally Invasive Surgery, or MIS, approach is often equated with reduced hospital stays and recovery times and is experiencing rapid growth within spine.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is designed to provide the least minimally invasive approach to lumbar spinal fusion while providing spine surgeons control and flexibility in implantation. The Luna 3D System features a small profile PEEK implant designed to expand in three dimensions within the disc space, allowing surgeons to restore height via a posterior approach while providing the stable fixation of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 360 Implant is delivered through a small diameter cannula into the disc space and then expanded with the insertion of a middle section. When the cannula is removed, bone graft is placed in the middle of the implant and the implant is locked in place with a locking wire.

About Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by InterWest Partners, Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.

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