Radiculopathy

MCRA CRO Assists Simplify Medical, Recently Acquired by NuVasive, on FDA-Approval for Two Level use of its Cervical Disc

Retrieved on: 
Wednesday, May 12, 2021
Spinal cord disorders, Radiculopathy, Organ systems, Myelopathy, Cervical, Spondylosis

"\nThe 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.

Key Points: 
  • "\nThe 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).
  • MCRA played a key role in this outcome and our ability to bring this treatment option to more patients around the world.
  • MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally.

NuVasive's Simplify Disc Receives FDA Approval for Two-Level Cervical Total Disc Replacement

Retrieved on: 
Tuesday, April 6, 2021
Anatomy, NuVasive, Branches of biology, Radiculopathy, Intervertebral disc arthroplasty, Cervical vertebrae, Cervical, Vertebral column, ACDF

SAN DIEGO, April 6, 2021 /PRNewswire/ --NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify Cervical Artificial Disc (Simplify Disc) received approval from the U.S. Food and Drug Administration (FDA) for two-level cervical total disc replacement (cTDR).

Key Points: 
  • SAN DIEGO, April 6, 2021 /PRNewswire/ --NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify Cervical Artificial Disc (Simplify Disc) received approval from the U.S. Food and Drug Administration (FDA) for two-level cervical total disc replacement (cTDR).
  • "This approval is an incredible achievement for the Simplify Disc and further broadens the growth opportunities for the NuVasive C360 portfolio," said Massimo Calafiore, executive vice president, Global Business Units at NuVasive.
  • "The Simplify Disc's clinical superiority to ACDF, coupled with its unique design properties, makes it an important tool in how spine surgeons treat cervical radiculopathy."
  • The Simplify Disc is part of the NuVasive C360 portfolio , which offers comprehensive, procedurally integrated solutions for the cervical spine across ACDF, posterior cervical fusion, and cTDR procedures.

NYU Langone Performs First U.S. Procedure with Newly Approved Device to Reduce Herniated Disc Recurrence

Retrieved on: 
Wednesday, June 12, 2019
Organ systems, Musculoskeletal system, Medical specialties, RTT, Spinal cord disorders, Neurosurgery, Pain, Human back, Spinal disc herniation, Spinal stenosis, Discectomy, Radiculopathy

The new implantation procedure improves outcomes for patients undergoing discectomy who suffer from radiculopathy and back pain due to herniated disc in the lower back.

Key Points: 
  • The new implantation procedure improves outcomes for patients undergoing discectomy who suffer from radiculopathy and back pain due to herniated disc in the lower back.
  • Disc herniation is one of the most common causes of lower back and leg painor sciaticain adults.
  • A herniated disc occurs when a fragment of the disc nucleus protrudes through a rupture in the annulus, thereby compressing the nerve, and causing pain.
  • NYU Langone's Spine Center provides excellent nonsurgical and surgical treatment of degenerative spine conditions such as herniated disc and spinal stenosis, and spinal deformities including scoliosis and kyphosis.