DECIMA SPINE The Simple Approach to Treat Lower Back Pain

Transcription

1 DECIMA SPINE The Simple Approach to Treat Lower Back Pain PDS/FCD-2 System The first, and only PERCUTANEOUS Bilateral Facet Augmentation System, that can treat L5-S1 effectively.

2 Biomechanical data shows that this device has the ability to treat degenerative disc disease (DDD) and spinal stenosis by significantly decreasing extension motion and reducing intradiscal pressures at the treated level without causing long term degenerative effects on adjacent levels. AP and Lateral Views of PDS/FCD-2 Placement into Model Cross-sectional pressure distribution during extension (peak: MPa) (a) Intact model: 8 Nm bending moment (peak: MPa) (b) Instrumental model: 8 Nm bending moment PDS/FCD-2 System Design Qualification Decreases intradiscal pressure Reduces annular pressure/strain Preserves Posterior Disc Height and Foraminal Areas during all ROM Prevents facet hypertrophy Disc Pressure (PA): extension 2

3 The PDS/FCD-2 System has the benefit of being a completely percutaneous one, which can be used at all levels of the lumbar spine, including L5-S1. The PDS/FCD-2 System limits painful spinal motion, enlarges the foramina, and achieves intradiscal decompression. Fig. 2. Fluoroscopic images marked with red lines showing a method of calculating fluoroscopic data. TABLE 4 Change in posterior disc height and foraminal area from neutral to extension* Change in Height (mm) Change in Area (mm) Specimen Intact Instrumented Diff % Diff Intact Instrumented Diff % Diff A B C D E mean 0.64 ± ± ± ± ± ± ± SD *.p = 002 for change of height, and p = for change of area. Source: Sylvain Palmer, M.D., Andrew Mahar, M.S., Richard Oka, B.A. Biomechanical and radiographic analysis of a novel, minimally invasive, extension-limiting device for the lumbar spine. Neurosurg Focus. 22 (1):E4,

4 A1 A2 Item Description Quantity Part Number A1 PDS/FCD-2 ANCHOR / A2 PDS/FCD-2 STABILIZER / PDS/FCD-2 System (Instruments) 1 Item Description Quantity Part Number 1 Access Needle* *Access Needle is supplied separately from the procedure system 4

5 PDS/FCD-2 System Instruments with Tray, Item Description Quantity Part Number 2 PDS/FCD-2 Kirschner Wire (0.062, 1.6mm) PDS/FCD-2 Slap Hammer PDS/FCD-2 Pre-Drill (3.0mm) PDS/FCD-2 Tap (4.5mm) PDS/FCD-2 Countersink PDS/FCD-2 Driver PDS/FCD-2 Insertion Tool PDS/FCD-2 Removal Driver PDS/FCD-2 Quick-Connect Handle DECIPORT Access Tool PDS/FCD-2 Tray Assembly PDS/FCD-2 System Instruments with Tray Only device that can treat L5-S1 effectively Least invasive over-the-wire percutaneous device Technically easier Less hardware implanted in patient Less post-operative pain Significantly less OR time One-size-fits-all One small instrumentation tray 5

6 L4 - L5 Complete Versatility 2 - Level L5 - S1 6

7 PDS/FCD-2 System from Decima Spine DECIMA SPINE The Simple Approach to Treat Lower Back Pain 7

8 Visit to learn more about Decima Spine, our products available outside the U.S, our educational services including our Surgery Meeting/Exhibit Schedule, and a listing of our Distributors worldwide. DECIMA SPINE The Simple Approach to Treat Lower Back Pain Decima Spine, Inc. 986 SE 42 Street Suite B Reparto Metropolitano San Juan, PR United States of America Ph Distributor: Manufactured by Interventional Spine Decima Spine, PDS/FCD-2 System, are marks registered with the U.S. Patent and Trademark Office. As of the date of print, Decima Spine has several issued and pending U.S. patents The products have been assessed in conjunction with the Notified Body as applicable, and are considered to meet the Essential Requirements and so bear the CE Marking of Conformity Decima Spine, Inc Rev. D