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CTDR

CTDR

CTDR

Product catalog summary
Introduction
This document provides an overview of the Simplify Cervical Disc, a medical device designed to treat cervical disc degeneration while preserving spinal motion. It is intended for informational purposes and should not replace professional medical advice.

Cervical Disc Degeneration
Cervical disc degeneration occurs when the discs between the vertebrae wear down, causing stress and potential pain, tingling, numbness, or weakness in the neck and arms. The Simplify Cervical Disc may be a suitable treatment option for those diagnosed with this condition.

Why Simplify Cervical Disc?
Implant Design: The disc is designed to treat symptoms of cervical disc degeneration and preserve spinal motion. It offers various disc height options to match healthy disc spaces.
Implant Materials: Made from PEEK with titanium coating and a ceramic core, the materials are nickel-free and allow for MRI imaging post-surgery.

Candidate Criteria
The Simplify Cervical Disc is intended for patients with cervical disc degeneration at one or two levels. Candidates are typically treated non-surgically first, and surgery is considered if symptoms persist or worsen.

Warnings and Risks
The device should only be used by trained professionals. Risks include serious bleeding, neurological damage, and potential for reduced cervical motion. Complications may include numbness, weakness, infection, and potential need for additional surgery.

Contraindications
The Simplify Cervical Disc should not be used in patients with active infections, osteoporosis, allergies to implant materials, severe facet disease, or unstable cervical spine conditions.

Legal and Safety Information
The device is restricted to sale by or on the order of a trained physician. Additional safety information is available at nuvasive.com/eIFU.
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Catalog excerpts

CTDR-1

Simplify Cervical Disc Designed to treat conditions and symptoms associated with cervical disc degeneration while helping you keep your motion This booklet provides general information on Simplify Cervical Disc. It is not meant to replace any personal conversations that you might wish to have with your physician or other member of your healthcare team. Not all the information here will apply to your individual treatment or its outcome.

 Open the catalog to page 1
CTDR-2

It’s hard to live in pain. Is cervical disc replacement right for you? Cervical disc degeneration occurs when one or more of the discs between the vertebrae (small bones that form the spinal column) begins to wear. This adds stress to the disc, nearby joints, muscles, and nerves. It may cause pain, tingling, numbness, and/or weakness in the neck and arms. If you’ve been diagnosed with or are experiencing unwanted effects of cervical disc degeneration, cervical disc replacement with an artificial disc like Simplify Cervical Disc might be right for you. Please speak to your physician to understand...

 Open the catalog to page 2
CTDR-3

Why Simplify Cervical Disc? Implant design • Simplify Cervical Disc is designed to treat conditions and symptoms associated with cervical disc degeneration, while preserving motion of the spine. • Disc height options are designed to closely match patients’ healthy disc spaces. Implant materials • Simplify Cervical Disc’s material combination of PEEK (medical-grade plastic) endplates with titanium coating and a ceramic core is nickel-free. • These materials allow for imaging after surgery using magnetic resonance imaging* (MRI) instead of a CT scan.

 Open the catalog to page 3
CTDR-4

Candidate: The Simplify Cervical Disc is a cervical artificial disc used for disc replacement. The disc is used in patients with cervical disc degeneration at one or two levels in your neck. This degeneration may cause pain, numbness, or weakness. A doctor may recommend Simplify Cervical Disc surgery based on your symptoms as confirmed by X-rays, CT, and/or MRI. Your doctor will tell you if you are a candidate for this procedure. You will likely be treated non-surgically first. This often includes rest, physical therapy, and injections. If your treatments do not provide relief after 6 weeks or...

 Open the catalog to page 4

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.