Benvenue Medical Presents Clinical Evidence on Luna and Kiva Systems at SMISS Annual Forum ‘16

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, today announced key clinical data presentations and company events for the Luna 3D Multi-Expandable Interbody Fusion System and Kiva VCF Treatment System at the Society of Minimally Invasive Spine Surgery (SMISS) Annual Forum ‘16 Oct. 13-15 in Las Vegas.

Data Presentations

• “Multi-Expandable Cages for Minimally Invasive Posterior/Transforaminal Lumbar (P/TLIF) Interbody Fusion – A Preliminary Report” (Paper #38) will be presented by Dr. Jeffrey Coe of the Silicon Valley Spine Institute (Campbell, California) on Saturday, Oct. 15 at 11:17 a.m. The podium presentation will highlight early experience and encouraging outcomes with the Luna Interbody Fusion System in minimally invasive P/TLIF, including absence of nerve retraction injuries and restoration of disc height, segmental lordosis, and foraminal height, along with lack of subsidence and maintenance of sagittal correction.
• “Serious Adverse Events Associated with Re-admission through One Year after Two Different Approaches to Vertebral Augmentation” (Paper #27) will be presented by Dr. Douglas Beall of Clinical Radiology of Oklahoma (Edmond, Oklahoma) on Friday, Oct. 14 at 11:45 a.m. The podium presentation will review serious adverse events requiring unplanned re-admission for patients who had vertebral augmentation using the Kiva VCF Treatment System as compared to balloon kyphoplasty.
• “Superior Articular Process Interbody Reconstruction: Feasibility and Short Term Clinical Outcomes of a Novel Posterior Lumbar Interbody Fusion Approach” (Poster #22) will be moderated by Dr. Joshua Ammerman of Washington Neurosurgical Associates (Washington, DC). The poster highlights Dr. Ammerman’s novel posterior minimally invasive approach to safely access the lumbar disc without intrusion into the spinal canal by use of the Luna 3D interbody cage to restore disc height as a means to achieve indirect canal and foraminal decompression.
• “Community Practice Experience with Subsequent Vertebral Compression Fractures during the Year after Vertebral Augmentation using an Expandable Implant” (Poster # 17) will be moderated by Dr. Ryon Hennessy of Orthopedic Specialists (Elmhurst, Illinois). The poster reviews the rate of subsequent vertebral compression fractures in the year following vertebral augmentation with the Kiva VCF Treatment System.

“At SMISS 2016, we will be presenting much anticipated early clinical experience with our Luna 3D Interbody Fusion System, highlighting the benefits of the multi-expandable implant,” said Robert K. Weigle, CEO of Benvenue Medical. “We will also be presenting important data on our Kiva VCF Treatment System showing its positive impact on potentially reducing subsequent fractures and other adverse events compared to balloon kyphoplasty.”

Benvenue will also exhibit at booth #100 and sponsor the “Elevating Surgical Outcomes: Sagittal Correction and Height Restoration with Expandable TLIF and VCF Implants” Technology Workshop presented by Dr. Coe on Saturday, Oct. 15 at 7:30 a.m.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is designed to provide one of the largest yet least invasive devices for posterior lumbar interbody spinal fusion. Cleared by the U.S. Food and Drug Administration in November 2014, the Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint and secondarily in height, allowing surgeons to effectively restore height via a posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height 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 the Kiva VCF Treatment System

The Kiva VCF Treatment System provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. Kiva was recently launched in the U.S. and it is commercially available in Europe. Kiva has been shown, in at least three comparative studies with a total of more than 500 patients, to meet or exceed the performance of balloon kyphoplasty, the standard of care. Kiva is indicated for the reduction and treatment of spine fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

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 DeNovo Ventures, Domain Associates, Esquilime Partners, InterWest Partners, Technology Partners and Versant Ventures. 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.