First Surgical Case Using CASCADIA Lateral Completed Following Receipt of FDA 510(k) Clearance and a CE Mark
LEESBURG, Va., Jan. 08, 2016 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it has recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CASCADIA™ Lateral Interbody System featuring Lamellar Titanium Technology™, the Company’s innovative and proprietary technology that uses 3D printing with the goal of allowing for bony integration throughout an implant. In addition to U.S. regulatory clearance, K2M also received a CE Mark for the system, which allows the Company to expand the global availability of the product.
K2M’s Lamellar Titanium Technology uses an advanced 3D printing method to create structures that were once considered impractical with traditional manufacturing techniques. Starting with a titanium powder, the implants are grown through the selective application of a high-energy laser beam, allowing for the incorporation of both a porosity and surface roughness that pre-clinical data have associated with bone growth activity.*
“By incorporating the porosity and rough surfaces of the Lamellar Titanium Technology into the CASCADIA Lateral interbodies, an alternative now exists to the traditional PEEK and Titanium cages commonly used in direct lateral fusion procedures,” stated Dr. Pierce Nunley, director of the Spine Institute of Louisiana, who completed the first surgical case using CASCADIA Lateral in December 2015. “The design of the CASCADIA Lateral implant offers me a greater bone graft volume than my normal ALEUTIAN® PEEK implant, while increasing the endplate contact surface area and still allowing me the ability to radiographically evaluate the fusion.”
K2M's Lamellar Titanium Technology incorporates titanium with a surface roughness of 3-5 microns and is designed to allow for direct bony ongrowth.* The technology also incorporates 500 micron longitudinal channels throughout the implant which, in conjunction with traverse windows, create an interconnected lattice designed to allow for bony integration.* Lamellar Titanium Technology exploits the material properties of titanium in conjunction with a product design that incorporates an approximately 70% porosity to mitigate the device’s radiographic signature.
The CASCADIA Lateral Interbody System features a reverse hourglass implant design that allows for increased endplate contact compared to an ALEUTIAN implant and without sacrificing internal bone graft volume. The system includes a full range of implant sizes and is designed to work in conjunction with theRAVINE® Lateral Access System, offering a full line of instrumentation for the far lateral transpsoas approach.
“We are pleased to receive FDA 510(k) clearance and a CE Mark for the CASCADIA Lateral Interbody System, further expanding the offering of our proprietary Lamellar Titanium Technology, which uses 3D printing and is designed to allow for bony ongrowth and ingrowth,” stated Eric Major, K2M's President and CEO. “These regulatory milestones, coupled with the successful completion of the first surgical case late last year, underscore our commitment to expanding our minimally invasive spine portfolio by bringing innovative and differentiated technologies and products to the global spine market.”
CASCADIA Lateral is K2M’s third product to feature its Lamellar Titanium Technology. The Company also received FDA 510(k) clearance and a CE Mark for the CASCADIA AN and TL Interbody Systems in 2015.
For more information on Lamellar Titanium Technology, the CASCADIA Interbody Systems, and K2M's complete product portfolio, visit www.K2M.com.
* Supporting literature and data on file. Pre-clinical data may not represent clinical results.
K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.
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Media Contact:Zeno Group on behalf of K2M Group Holdings, Inc.Marcie Kohenak, 202-965-7811Westwicke Partners on behalf of K2M Group Holdings, Inc.Marcie.Kohenak@ZenoGroup.com Investor Contact:K2M@westwicke.comMike Piccinino, CFA, 443-213-0500
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