SafeGuard
Limit uncertainty with a safe and simple carpal tunnel release procedure
A two-component system that simplifies the “Mini Open” surgical technique while providing a high-level of control and median nerve protection.
System features & benefits
- An Instrumentation with a protective guide and knife SafeGuard™ Knife which provides high level of control.
- A direct visualization of median nerve to define the “Safe Zone” for carpal tunnel release.
- Procedure with no need for endoscopic equipment. The 2 instrument system reduces the Operating Room set-up time.
Indications
The SafeGuard™ Mini Carpal Tunnel Release System is indicated in the treatment of carpal tunnel syndrome and in addition to that, for those patients who fail to respond to a full course of conservative treatment.
Contraindications
Recurrenty after a previous carpal tunnel release.
- Distortion of anatomy.
- Repeat carpal tunnel release.
- Neurologic defects.
- Previous soft tissue injury at the surgical site.
Ordering Information
Each knife is provided sterile in packaging and is a single-use, disposable product.
- The guide is non-sterile and must be removed from packaging and autoclaved prior to surgery.
Product Catalogues
Integra® SafeGuard™ Mini Carpal Tunnel Release System
Guide
| Reference | Description |
|---|---|
| 08-0001 | Integra® SafeGuard™ Guide |
Cutting Knife
| Reference | Description |
|---|---|
| 08-0003 | Integra® SafeGuard™ Knife |
| 08-0005 | Integra® SafeGuard™ Knives (set of 5) |
Component Materials
Guide
| Reference | Description |
|---|---|
| 316L | Stainless Steel as per ASTM A276 |
Cutting Knife
| Reference | Description |
|---|---|
| PE955I | Handle Polyethylene |
| AISI.SAE 51440 A | Blade Stainless Steel |
Regulatory Information
Products mentioned in this page are CE class I and IIa devices. Please contact Integra customer service should you need any additional information on devices classification.
Integra LifeSciences Corporation
4900 Charlemar Drive – Building A
Cincinnati – OH 45227 – USA
Phone: +1 (609) 275-0500
Integra LifeSciences Services (France) SAS
Immeuble Séquoia 2 97 allée Alexandre Borodine
Parc technologique de la Porte des Alpes
69800 Saint Priest • FRANCE
Phone: +33 (0)4 37 47 59 00
Fax: +33 (0)4 37 47 59 99
integralife.eu
Legal information
Please contact Integra customer service should you need any additional information on devices classification.
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.
All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.
Consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.
Non contractual document. Integra reserves the right, without prior notice, to modify the products in order to improve their quality.
WARNING: Applicable laws restrict these products to sale by or on the order of a physician.
Integra and the Integra logo are registered trademarks of Integra Lifesciences Corporation.
EndoRelease is a trademark of Integra LifeSciences Corporation.
Last revision date: 10/2016. 0550089-1-EN
For complete product information, please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions, and instructions for use.
