SOURCE: Spine Wave, Inc.

Spine Wave, Inc.

July 01, 2015 08:00 ET

Spine Wave Announces the Commercial Launch of the Leva™ Interbody Device System

The Leva™ Interbody Device System Allows Spine Surgeons to Maximize Bone Graft Volume in a Novel, Expandable Titanium Device

SHELTON, CT--(Marketwired - Jul 1, 2015) -  Spine Wave, Inc. is committed to the commercialization of high-quality, innovative medical devices for the treatment of spinal disorders. Through the StaXx® family of products, Spine Wave pioneered the field of expandable spacers and with this commercial launch of the Leva Interbody Device, the company is significantly broadening its product offering in this important and rapidly growing market segment. 

The Leva Interbody Device is an expandable titanium implant that is optimized for ease of insertion and for maximum post expansion bone graft capability. The retractable bullet nose design facilitates insertion, while the instrumentation provides controlled expansion within the interbody space. Perhaps most important, following the implantation and expansion of the device, the Leva Interbody Device is easily filled with bone graft with up to 68.5% of the total implant volume being available for graft material. The Leva Interbody Device is also available in a non-expandable version designed to appeal to surgeons whose primary interest is maximizing graft volume within a titanium device.

"The StaXx® line of expandable PEEK spacers has a well-established track record in the marketplace and we are very pleased to complement our existing product offering with a novel, titanium device designed to maximize the opportunity for bone grafting," said Mark LoGuidice, Spine Wave Chief Executive Officer. "In our recently completed limited market release, the Leva Device was clinically implanted over 100 times and the feedback from surgeons has been overwhelmingly positive. We are confident that this device will become an important part of our product offering and with that in mind we are aggressively ramping manufacturing to meet the anticipated demand."

Dr. Dennis Crandall, Medical Director of Phoenix, AZ-based Sonoran Spine, gained significant clinical experience with the Leva Interbody Device over the past few months. Dr. Crandall stated, "Successful fusion surgery is all about proper disc preparation followed by maximizing endplate contact with bone graft. The Leva expandable cage accommodates a significant increase in the amount of bone graft within the device, which can be filled entirely after the cage is deployed. The open architecture of the expandable implant not only allows for complete backfill of the cage, but it also facilitates backfill of the entire disc with bone. For the first time, bone graft can be continuous, front to back, left to right, and top to bottom, all connecting through the open design of the expanded cage. If there is an expandable device on the market with a similar capacity for graft volume, I have not seen it." Dr. Crandall is Founder of the Sonoran Spine Research and Education Foundation, Clinical Professor at the University of Arizona College of Medicine, and faculty for the Mayo Clinic-Scottsdale's Orthopaedic Surgery Residency Program.

About Spine Wave
Spine Wave's product portfolio features many highly differentiated technologies including the StaXx® IB Expandable Interbody Device and the StaXx® XD Expandable Device, which has a seven year proven track record in posterior surgery. The StaXx® IBL Expandable Interbody Device, the Abacus® Lateral Spacer System and the XLR® Lateral Access System represent Spine Wave's offering for the lateral surgical approach. In addition to the expandable spacer technologies, the Sniper® Spine System has developed a reputation as a leading MIS screw system and is now complemented with the Annex® Adjacent Level System. Spine Wave provides the simple yet versatile CapSure® PS3 Spine System which is proving to be a high quality, user friendly, traditional screw system. Spine Wave is dedicated to continuously delivering a robust and highly differentiated product pipeline, with a strong emphasis on minimally invasive solutions that will meet and exceed the expectations of our spine surgeon customers.

The Company is growing rapidly and continues to recruit new sales managers and independent distributors to fuel the growth. For further information on all of the Spine Wave products please visit the Company's website at www.SpineWave.com.

Contact Information

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    Terry Brennan
    Chief Financial Officer
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    203-712-1810