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SeaSpine Holdings Corporation, a global medical technology company focused on surgical solutions for the treatment of spinal disorders, recently 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.”
For Further Information
More on the MIS interbody fusion market in in the United States can be found in a report suite published by iData Research entitled the U.S. Market for Minimally Invasive Spinal Implants. The suite covers reports on the following markets: Spinous Process Fixation, MIS Interbody Fusion, MIS Pedicle Screws, and MIS Sacroiliac Joint Fusion.
The iData report series on minimally invasive spinal implants covers the U.S., Australia, Japan, South Korea, China, Taiwan, Argentina, Brazil, Mexico, and 15 countries in Europe including Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, the U.K., and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about MIS spinal implant market data or procedure data, register online or email us at [email protected] for a U.S. Market for Minimally Invasive Spinal Implants brochure and synopsis.
About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Dental Operatory Equipment, X-Ray Imaging, Vascular Access, Peripheral Vascular, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Diagnostic Imaging, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Oncology, Ultrasound, Laparoscopy, Urology, Gynecology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large and Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics and more.
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