MCRA, LLC, the leading privately held medical device and biologics advisory firm and Clinical Research Organization (CRO) integrating the U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Medical Device Cybersecurity, is pleased to announce its role in the successful management and execution of Simplify Medical’s two clinical studies and approvals by the U.S. Food and Drug Administration (FDA) for the Simplify Cervical Artificial Disc (Simplify Disc) to be used at one-level and two contiguous levels in the cervical spine.
Abigail Allen, MCRA’s Vice President of Clinical Affairs, said, “MCRA is honored to have supported Simplify Medical with the approval of their two-level disc just six months after the one-level approval. It has been a true testament to the teamwork and collaboration between the two companies, and all of our sites, to get these studies enrolled, locked, and approved during the challenges 2020 brought to us all.”
The Simplify Disc is designed to offer best-in-class capabilities for cervical total disc replacement across key performance functions including a radiologic design, physiologic motion, and various anatomic disc heights. The device is indicated for use in patients with intractable radiculopathy with or without neck pain, or myelopathy, at one or two contiguous cervical levels (C3-C7). The Simplify Disc demonstrates clinical superiority to ACDF1 and has the highest overall clinical success rate at both one- and two levels compared to any other approved cervical disc.
Kyle Malone, MS, Vice President of Clinical, Medical, and Regulatory Affairs at NuVasive, Inc., said, “NuVasive would like to recognize MCRA for their regulatory, clinical, and quality support, expertise, and responsiveness provided throughout the one- and two-level Simplify Disc clinical trials and PMA submissions. MCRA played a key role in this outcome and our ability to bring this treatment option to more patients around the world. We look forward to their continued partnership moving forward.”
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Justin Eggleton, MCRA’s Vice President of Spine Regulatory Affairs, said, “The Simplify Disc’s expanded labeling to include use at two contiguous cervical levels was earned through a rigorous clinical study that demonstrated a positive benefit-risk profile in this patient population. While the original PMA approval focused on the novel biomaterials and lower device heights that address an unmet clinical need, the two-level study highlighted the overall benefits of device design and kinematic profile with two cervical implants in series. We look forward to continuing to work with NuVasive as the result of its acquisition of Simplify Medical and the different pathways available to continue building on clinical performance set by the IDE studies and FDA approvals.”
To date, MCRA’s clinical and regulatory teams have supported fifteen successful PMAs, including eight spinal technologies.
Source: Biospace
