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Osseoflex® SN steerable needle

 

Osseoflex-SN-Prod-pg
The Osseoflex® SN
is a 10 gauge steerable, articulating needle, which allows unparalleled navigation within the vertebral body. The Osseoflex SN steerable needle provides direct unipedicular access to the entire vertebral body for percutaneous vertebral augmentation with or without cavity creation (PVA/PVACC). Channels or cavities are achieved by steering the device and disrupting bone, thereby creating a void within the vertebral body. After a cavity or channel is created, polymeric bone cement is injected through the Osseoflex SN needle to fill the previously created void.

The Osseoflex SN steerable needle is designed for use with PMMA bone cement for the treatment of vertebral compression fractures.

Osseoflex® SN/SN+ Steerable Needle Sales Sheet (PDF)
Osseon Product Brochure (PDF)

Features

Steerable and Articulating:

Because of the unique Osseoflex SN distal tip design, the physician has complete control over the articulation and direction of the delivery needle at all times, providing direct access to the entire vertebral body. The following graphics highlight the Osseoflex SN’s dynamic range of motion for precise delivery of bone cement.

The Osseoflex SN steerable needle combined with PMMA bone cement is the first system to provide this degree of flexibility and control, which allows for specific cement delivery and fracture correction in a single device for percutaneous vertebral augmentation.

 

Data on file at Osseon LLC

Description and Indications for Use

Osseoflex SN Description

The Osseoflex SN steerable vertebral augmentation needle is a mechanical device used to disrupt bone by steering and channeling through the bone, creating a void within a vertebral body. After the bone is disrupted, polymeric bone cement is injected through the Osseoflex SN steerable vertebral augmentation needle to fill the previously created void.

Osseoflex SN Indications for Use

The Osseoflex SN steerable vertebral augmentation needle is used during a vertebroplasty or kyphoplasty to fill a fractured vertebral body with polymeric bone cement. Painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

Product Specifications

The Osseoflex SN steerable needle includes the following components:

Osseoflex SN steerable and flexible needle

  • Size = 10 gauge compatible

2 cannulas

  • Size = 10 gauge
  • Both cannulas have 45 degree beveled edges

4-point Diamond tip stylet

Beveled tip stylet

Biopsy needle

  • Size = 12 gauge