SeaSpine Holdings (SPNE) Reports FDA 510(k) Clearance of Shoreline ACS System
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SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Shoreline™ ACS Anterior Cervical Standalone System, featuring TruProfile™ technology. TruProfile offers a low profile plate designed to minimize cephalad-caudal encroachment onto the vertebral bodies and maximize the distance from adjacent disc spaces. The Shoreline ACS anterior plate is 1.6mm thick, providing minimal profile on the anterior spine.
The Shoreline ACS System is designed to maximize intraoperative flexibility by offering a full complement of zero and low-profile plating options, including two-, three- and four-hole variations, as well as 10 degree lordotic implants. This complement of options provides surgeons the ability to address the variety of patient anatomical needs and surgical scenarios that may be encountered in the operating room.
“SeaSpine set out to build a product platform that reflects the critical needs of its surgeon customers, and it shows,” stated James Bruffey, MD. “The design of this system addresses common challenges, without sacrificing ease of use and technical reliability. I believe Shoreline ACS will provide a safe and effective option for my cervical fusion surgery patients.”
The Shoreline ACS System incorporates proprietary NanoMetalene® surface technology. NanoMetalene interbody implants are designed to provide the benefits of a titanium surface while retaining the benefits associated with traditional PEEK devices, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging. NanoMetalene describes a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK-OPTIMA® polymer from INVIBIO®. It is applied in a proprietary, high-energy, low-temperature process that differs from other coating applications and maximizes implant surface area with titanium nanotopography.
“We are excited about the Shoreline ACS System because it provides advantageous intraoperative flexibility, while addressing key clinical challenges often encountered by surgeons,” stated Keith Valentine, Chief Executive Officer of SeaSpine.
SeaSpine will be conducting initial cases through a limited launch over the next few months and expects a full commercial launch in the first half of 2017.
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