In a clinical study doing a side-by-side comparison, MESA Rail showed better curve correction than standard circular rods
LEESBURG, Va., July 14, 2016 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (NASDAQ:KTWO) (the "Company" or "K2M"), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced results from a study published in the July 15 issue of the journal Spine. The study, entitled: A Uniquely Shaped Rod Improves Curve Correction in Surgical Treatment of Adolescent Idiopathic Scoliosis (AIS), found that K2M’s MESA Rail™ Deformity Spinal System results in significantly better major curve correction than standard circular rod constructs. MESA Rail features a beam-like design that provides enhanced rigidity to aid in the restoration of sagittal balance while maintaining a low profile.
The results showed that major curve correction was significantly better in the beam-like rod (BR) group (66%) compared to the circular rod (CR) group (57%), evidenced by whole spine standing antero-posterior and lateral radiographs that were taken pre-operatively and within seven days following the surgery. Further, the MESA Rail (BR) cohort showed shorter operative times, less blood loss, and shorter hospital stays when compared to the standard CR cohort. Both groups showed a slight decrease in thoracic kyphosis.
The findings, authored by Dr. Martin Gehrchen, Dr. Søren Ohrt-Nissen, Dr. Dennis W. Hallager, and Dr. Benny Dahl of Rigshospitalet at the University of Copenhagen in Denmark, were gathered from 129 surgical cases for patients treated for AIS between May 2011 and May 2015. Subjects were placed into two groups based on the rod they were treated with (BR or CR). The study utilized craniocervical instability (CCI) to eliminate bias caused by differences in preoperative flexibility and demonstrated that their results were not significantly influenced by a surgical learning curve. Long-term follow-up is needed to assess if correction is maintained over time.
"K2M is pleased to see published data supporting the MESA Rail Deformity Spinal System as a means for improving curve correction in patients surgically treated for AIS,” said Eric Major, President and CEO of K2M. “These findings reinforce that low-profile constructs—like MESA Rail with its unique beam-like design—are not only safe, but allow surgeons to achieve a better curve correction, while also reducing, in some patients, the frequency of implant-related discomfort or pain. K2M is committed to achieving the highest level of excellence in developing innovative technologies, such as MESA Rail, that increase the quality of life for patients suffering from complex spinal deformities.”
Key findings from the study will be presented by study authors Dr. Martin Gehrchen and Dr. Benny Dahl in an interactive session entitled: “Correcting & Maintaining Sagittal Balance in AIS – Current Concepts” at the 23rd International Meeting on Advanced Spine Techniques (IMAST) in Washington, D.C. on July 14. The session will begin at 5:30 p.m. in Salon 14.
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. Christian Emering, 212-299-8985 Christian.Emering@ZenoGroup.com Investor Contact: Westwicke Partners on behalf of K2M Group Holdings, Inc. Mike Piccinino, CFA, 443-213-0500 K2M@westwicke.com
Source:K2M Group Holdings, Inc.