Healthcare Industry News: HSMN NewsFeed
News Release - March 3, 2021
First U.S. Patient Treated With BAGUERA(R)C Cervical Disc ProsthesisLAGUNA HILLS, Calif., March 3, 2021 -- (Healthcare Sales & Marketing Network) -- Spineart USA Inc. announced today that clinical principal investigator, Dr. Domagoj Coric at Carolina Neurosurgery and Spine Associates in Charlotte NC, performed the first surgery in the two-level U.S. Investigational Device Exemption (IDE) Clinical Trial of the BAGUERA®C Cervical Disc Prosthesis. The BAGUERA®C implant is an investigational device designed to reconstruct the cervical disc. The goal of this surgery is to restore the height and preserve motion at that spinal level.
"The BAGUERA®C cervical disc is a modern generation artificial disc and the technique is straightforward compared to other devices I have used. I am excited to continue enrolling more patients and to start collecting outcome data," said Dr. Coric, Principal Investigator at Carolina Neurosurgery and Spine Associates.
Jerome Trividic, President of Spineart USA Inc., said, "The enrollment of the first patient in our BAGUERA®C two-level trial is an important achievement made possible by the relentless work of our employees and partner surgeons. We have embarked on an ambitious project to gather additional solid scientific evidence of safety and effectiveness for our BAGUERA®C artificial disc with the ultimate goal of providing spine surgeons in the United States and their patients with new treatment options."
ABOUT THE BAGUERA®C CERVICAL DISC PROSTHESIS
The BAGUERA®C Cervical Disc Prosthesis, developed by Spineart SA (Geneva, Switzerland), is an investigational device designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease. The BAGUERA®C is designed to maintain the natural behavior of a functional spinal unit. This design enables the BAGUERA®C nucleus to move in all six degrees of freedom, with independent angular rotations and translational motions.
ABOUT THE BAGUERA®C IDE CLINICAL TRIALS
The BAGUERA®C IDE trials, prospective, multi-center, randomized clinical studies, will evaluate the safety and efficacy of BAGUERA®C compared to the Mobi-C® cervical disc in the treatment of symptomatic cervical disc disease at a single- or two contiguous levels in the cervical spine. Each study will enroll approximately 300 subjects at up to 30 study sites in the U.S. Results of this pivotal clinical trial will be the basis of a premarket approval (PMA) submission to the U. S. Food and Drug Administration.
Spineart, a privately held medical device company based in Geneva (Switzerland), is focused on simplifying the surgical act by designing, developing and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients. Spineart is a pioneer in its field, having introduced unique patented and clinically validated technologies in the fields of Minimally Invasive Surgery, Motion Preservation, Fusion, Biologics, and Fractures Treatment. Spineart markets a complete portfolio combining traceable barcoded sterile packed implants with compact instrument sets, thus proudly promoting greater safety, cost-efficiency, and compliance at the hospital. Its 100% US subsidiary is located in Laguna Hills, California. For more information, visit www.spineart.com.
CAUTION—Investigational device. Limited by United States law to investigational use.
Source: Spineart USA
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