Healthcare Industry News: K2M
News Release - July 31, 2014
K2M Continues Momentum with Complex Spine & Minimally Invasive Line Extensions & Regulatory ClearancesLEESBURG, Va., July 31, 2014 -- (Healthcare Sales & Marketing Network) -- K2M Group Holdings, Inc. (KTWO) (the "Company" or "K2M"), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced the Company's recent product highlights, which include 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CASPIAN(R) Occipital Anchor Spinal System, the introduction of the SERENGETI(R) Minimally Invasive Retractor System in Japan, and the launch of the CAYMAN(R) Minimally Invasive Plate System in the United States, Australia and the United Kingdom.
"These highlights reaffirm K2M's continued commitment to evolving and expanding our technologies, specifically in the areas of complex spinal pathologies and minimally invasive procedures," stated Eric Major, K2M's President and CEO.
Enhancing K2M's Complex Spine Portfolio with CASPIAN Occipital Anchor Clearance
FDA clearance of CASPIAN Occipital Anchor marks the latest addition to the Company's complex spine portfolio. It provides surgeons—specifically those in the neurosurgical community— with another option in the CASPIAN product family, which already includes the CASPIAN Occipital Plate. CASPIAN Occipital Anchor allows for fixation behind the occiput, anchoring posterior cervical and thoracic constructs to the spine. The system provides a strong alternative to mid-line fixation and allows for flexible implant positioning to accommodate varying patient anatomy. K2M's MESA(R) Mini and DENALI(R) Mini systems are compatible with CASPIAN Occipital Anchor.
"CASPIAN Occipital Anchor is a good option for occipital fusions," stated Faheem Sandhu, MD, PhD, Professor of Neurological Surgery and Director of Spine Surgery at Georgetown University Hospital. "The low-profile system helps to maximize the amount of occipital bone for fusion and will be a strong alternative to plate systems, where hardware often obscures the occipital bone."
Expanding K2M's Minimally Invasive Offerings in the Global Spine Market
In addition to enhancing its complex spine portfolio, K2M also continued the global expansion of its minimally invasive technologies with the introduction of SERENGETI in Japan and the launch of CAYMAN Minimally Invasive in the United States, Australia and the United Kingdom.
SERENGETI is an existing K2M flagship minimally invasive product, featuring a flexible polymer Retractor that provides direct visualization and access to the screw heads to allow for simplified rod insertion. The Retractor is inserted with the screw, allowing for one-step, percutaneous placement of the implants. The Pharmaceuticals and Medical Devices Agency (PMDA) clearance of SERENGETI in Japan follows K2M's 2009 entrance into the Japanese market via its MESA(R) Spinal Systems. Similar to 510(k) clearance in the United States, the PMDA clearance allows for sale and distribution of SERENGETI and MESA in Japan.
The launch of CAYMAN Minimally Invasive follows K2M's first quarter release announcing FDA 510(k) clearance. The plate's single-level, stackable design allows for one-level and multi-level constructs. The low-profile, four screw construct features K2M's proprietary tifix(R) Locking Technology, a plate-screw locking technology whereby each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism. CAYMAN Minimally Invasive is specifically designed for insertion through the RAVINE(R) Lateral Access System, allowing surgeons to preserve the position of the lateral implant and insert the plate without repositioning the RAVINE Retractor.
According to Thomas Reilly, MD, an orthopaedic spine surgeon at Indiana Spine Group, "The CAYMAN Minimally Invasive Plate allows for the application of low-profile anterior instrumentation after placement of the lateral interbody without having to significantly modify the typical minimally invasive approach. For appropriate patients, this enables use of a stable, stand-alone lateral construct."
For more information on K2M's product portfolio, visit www.K2M.com.
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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