SeaSpine Holdings (SPNE) Reports FDA 510(k) Clearance for Mariner Posterior Fixation System

November 7, 2016 5:28 PM EST
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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 Mariner™ Posterior Fixation System.

The Mariner Posterior Fixation System is a pedicle screw system featuring modular threaded technology and accompanying instrumentation. Designed to reduce the number of trays needed for surgery, Mariner is intended to provide surgeons with multiple intra-operative options to facilitate posterior lumbar fixation. Key market differentiators of the Mariner System include in-situ modularity, motion limiting heads and rod versatility with both 5.5mm and 6.0mm offerings.

“In today’s hospital environment, the key is to have as many options as you can for your patient without overburdening your staff,” stated Douglas Orndorff, MD. “Mariner is versatile, yet simple to use. Ultimately, it lets me make intraoperative decisions seamlessly.”

Dr. Warren Yu, Director of Spine Surgery at George Washington Hospital commented, “Mariner’s state-of-the-art instrumentation and modular screw design provide me with the broad selection of implant configurations that I need to address the challenging patient anatomy I see in my adult spine practice – from basic degenerative to complex deformity cases.”

SeaSpine is conducting initial cases with the Mariner Posterior Fixation System through a limited launch that will continue over the coming months. The Company expects a full commercial launch of the Mariner System in the first half of 2017.

“The Mariner Poster Fixation System brings innovative features to the market and utilizes a modular design that increases surgeon flexibility while reducing the number of trays that need to be brought into the operating room,” stated Keith Valentine, Chief Executive Officer of SeaSpine. “The Mariner launch is an important enhancement to SeaSpine’s spinal hardware product offerings in the $1.8 billion posterior lumbar fixation market.”

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