Spineology Rampart One™ Standard ALIF Interbody Fusion System Gains FDA Clearance for Stand-Alone Use

Published: Jun 04, 2018

ST. PAUL, Minn.--(BUSINESS WIRE)-- Spineology Inc., announces FDA clearance of its Rampart One™ Standard ALIF device allowing it to be used with or without supplemental fixation.

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Spineology Rampart One (Photo: Business Wire).

Spineology Rampart One (Photo: Business Wire).

“Following the success of our beta launch, this stand-alone clearance will provide additional momentum as we prepare for the full market release of the Rampart One ALIF Interbody Fusion System,” said John Booth, CEO of Spineology.

The Rampart One ALIF Interbody Fusion System is another anatomy-conserving technology from Spineology. The system includes both standard and oblique interbody devices, each with integrated fixation screws and is designed to minimize vascular retraction and exposure to maximize safety. Additionally, Rampart One is manufactured from Invibio® PEEK-OPTIMA® HA Enhanced material to support bone on-growth.

“Minimal retraction and minimal exposure are very important for the anterior approach. The Rampart One instruments work collinear with the access, providing surgeons the ability to keep the incision to a minimum,” said Dr. Jeremy Shore of Boston, Massachusetts. “Additionally, divergent fixation screw angles and midline screw placement keep vascular retraction to a minimum.”

“Advanced biomaterials are showing great promise in enhancing patient outcomes. It’s very exciting to have access to an implant like Rampart One which is constructed from PEEK-OPTIMA HA Enhanced”, said Dr. Clifford Tribus of Madison, Wisconsin.

PEEK-OPTIMA HA Enhanced provides improved osteoconductive surfaces for bone on-growth while preserving the traditional benefits of PEEK-OPTIMA Natural including a modulus of elasticity similar to that of human bone, reduced stress shielding and artifact-free imaging.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

 

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

 
 

Source: Spineology Inc.

 

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