Dekompressor

Disc Dekompressor

A minimally invasive solution for

relieving pain and providing an

alternative to surgery.

Disc Dekompressor ®

Advanced technology. Measurable results.

Literature Number: 1000-906-001 Rev. DDDM/PSCopyright © 2009 StrykerPrinted in USA

Stryker Instruments4100 East Milham AvenueKalamazoo, MI 49001 USAt: 269 323 7700 f: 800 999 3811toll free: 800 253 3210www.stryker.com

The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Products referenced with TM designation are trademarks of Stryker. Products referenced with ® designation are registered trademarks of Stryker.

EMS Equipment

Patient Handling Equipment

Communications

Endoscopy

Navigation

Interventional Spine

Surgical Products

Biologics

Spine

Craniomaxillofacial

Trauma, Extremities, Deformities

Joint Replacements

Imaging

Neuro & ENT

Footnotes

1. Alò K, Wright RE, Sutcliffe J, Brandt SA. Percutaneous lumbar discectomy: clinical response in an initial cohort of 50 consecutive patients with chronic radicular pain. Pain Pract. 2004; 4(1):19-29

2. Carey TS, Garrett J, Jackman A, Mclaughlin C, Fryer J, Smucker D. The outcomes and costs of care for acute low back pain among patients seen by primary care practitioners, chiropractors, and orthopedic surgeons. The North Carolina Back Pain Project. N Eng J Med. 1995; 333(14):913-7

3. Amoretti N, David P, Grimaud A, Flory P, Hovorka I, Roux C, Chevallier P, Bruneton JN. Clinical follow-up of 50 patients treated by percutaneous lumbar discectomy. Clinical Imaging. 2006; 30(4):242-4

4. Alò KM, Wright RE, Sutcliffe J, Brandt SA. Percutaneous lumbar discectomy: one-year follow-up in an initial cohort of 50 consecutive patients with chronic radicular pain. Pain Pract. 2005; 5(2):116-23

5. Alò K, Wright RE, Fu ZJ. Open human torso laboratory dissection with annular and nuclear lumbar disc analysis pre and post Dekompressor®. Denver, CO: University of Colorado Health Sciences Center College of Medicine, Department of Anatomy; January 19/20, 2003

6. Wright R. Preclinical laboratory analysis of Dekompressor® percutaneous decompression in sheep and human cadaver discs: Internal Data. Fort Collins, CO: Colorado State University; May 2000

7. Onik G, Maroon J, Helms C, Schweigel J, Mooney V, Kahanovitz N, Day A, Morris J, McCulloch JA, Reicher M. Automated percutaneous diskectomy: initial patient experience. Work in progress. Radiology. 1987; 162(1 Pt 1):129-32

8. Davis, GW, Onik G. Clinical experience with automated percutaneous discectomy. Clin Orthop Relat Res. 1989; 238:98-103

9. Onik G, Mooney V, Maroon JC, Wiltse L, Helms C, Schweigel J, Watkins R, Kahanovitz N, Day A, Morris J, et al. Automated percutaneous discectomy: a prospective multi-institutional study. Neurosurgery. 1990; 26(2):228-32; discussion 232-3

10. Maroon JC, Onik G, Sternau L. Percutaneous automated discectomy. A new approach to lumbar surgery. Clin Orthop Relat Res. 1989; 238:64-70

11. Gill K, Blumenthal SL. Clinical experience with automated percutaneous discectomy: the Nucleotome system. Orthopedics. 1991; 14(7):757-60

12. Gill K, Blumenthal SL. Automated percutaneous discectomy. Long-term clinical experience with the Nucleotome system. Acta Orthop Scand Suppl. 1993; 251:30-3

13. Castro WH, Jerosch J, Hepp R, Schulitz KP. Restriction of indication for automated percutaneous lumbar discectomy based on computed tomographic discography. Spine. 1992; 17(10):1239-43

14. Yeo SJ, Tay BK. Clinical experience with automated percutaneous discectomy. Singapore Med J. 1993; 34(4):313-5

15. Mathews R, Kent G, Miller M. APLD: A prospective study in an outpatient surgical setting. ISIS Newsletter, 1997

16. Carragee EJ, Han MY, Yang B, Kim DH, Kraemer H, Billys J. Activity restrictions after posterior lumbar discectomy: a prospective study of outcomes in 152 cases with no postoperative restrictions. Spine. 1999; 24(22):2346-51

17. Mariconda M, Galasso O, Secondulfo V, Rotonda GD, and Milano C. Minimum 25-year outcome and functional assessment of lumbar discectomy. Spine. 2006; 31(22):2593-9

* Information current as of 6.30.09

Ordering Information

Dekompressor KitsIncludes: One percutaneous discectomy probe, one introducer cannula with bevel stylet, one probe cleaner

407-265-000 6" 13 Gauge Straight Dekompressor Kit



407-251-000 6" 17 Gauge Curved Dekompressor Kit


407-260-000 9” 17 Gauge Straight Dekompressor Kit


Includes: One percutaneous discectomy probe, one introducer cannula with bevel stylet, one blunt stylet, one probe cleaner

Cannulae Sterile; 5 per pack. For use with 6" 17 gauge straight or curved Dekompressor kits:

407-253-000 6" 17 Gauge Straight Introducer with Stylet

407-254-000 6" 17 Gauge Curved Introducer with Stylet

407-255-000 6" 17 Gauge Blunt Introducer with Stylet

For use with 6” 13 gauge straight Dekompressor kit:

407-275-000 6” 13 Gauge Straight Introducer with Stylet

For use with 6” 15 gauge straight Dekompressor kit:

407-276-000 6” 15 Gauge Straight Introducer with Stylet

Lower back with radicular leg pain is a

condition affecting nearly 10 million people.

The cost is measured in more than just pain:

medical treatment is estimated to cost $20

billion annually.1,2 Percutaneous discectomy

using the Stryker Dekompressor System gives

you a highly effective treatment for relieving pain

due to bulging discs or contained herniations.

An innovative solution for a costly problem.

Physical therapyMedication Bed rest

Open surgery

Noninvasive InvasiveMinimally Invasive

This minimally invasive approach completes

the continuum of care for patients who haven’t

responded to conservative treatments, but want

an alternative to surgery. It reduces pain, shortens

recovery time, and often returns patients to

their previous level of activity.2 Developed with

respected medical professionals, use of the

Stryker Dekompressor for percutaneous

discectomy can benefit your patients, your

practice, and the healthcare system.

Figure 1. The continuum of care.

The Stryker Dekompressor System is an innovative minimally

invasive disc removal system for disc bulges or contained

herniations. It was developed with leading practitioners

for measurable, selective extraction of herniated nucleus

pulposus without annular or nuclear disruption.1,4,5,6

Using a patent-pending Archimede’s pump principle,

Stryker’s Dekompressor provides a highly efficient method

for removing intervertebral disc nucleus through the

smallest available channel under fluoroscopic control.

Smart technology. Quantifiable results.

The Stryker Disc Dekompressor is used in the aspiration of disc

material during percutaneous discectomies. Material removed

can also be used for disc biopsies.

Product Benefits• Removesquantifiablediscmaterial

• NocapitalequipmentrequiredUnique to Stryker*

• Nothermaldamagetothenerveroot

• ProvidessampleforbiopsyUnique to Stryker*

• Fourcannulasizesthatregulatetheamountofmaterialaspirated

• Multiplelengths,gauges,andshapesallowprocedurecustomization

• Maybeusedinthelumbar,thoracic,andcervicalregionsofthespine

Results Compared to Surgery• Possiblereductionin:

o Perineural scarring

o Postoperative fibrosis

o Permanent structural alterations

o Spinal instability

• Decreasedcomplicationrate:0.5%vs.3%

with open surgical discectomy4,16

• Lowerre-herniationrate:5%vs.10-15%

compared to open lumbar discectomy17

• Noincisionrequired

• Decreasein:

o Anesthesia

o Procedure time

o Recovery time

Chart 1. Please refer to this chart for Stryker recommended product pairings.

Probes are straight unless otherwise indicated.

Probes

6" Dekompressor

9" Dekompressor

3" Dekompressor

Regions of Spine19 Gauge13 Gauge 15 Gauge 17 Gauge

X†

X X X

X

X**

† Available straight or blunt** Available straight, blunt, or curved

Uses

Cervical

Thoracic / Lumbar

Lumbar

Procedure BenefitsBenefits of Stryker Disc Decompression are reported

to include excellent success rates,1,4 maintained

annular integrity,1,5,6 low outpatient treatment costs,

rapid rehabilitation, and low risk.

• Significantpainrelief1,4

• Reduceduseofanalgesics1,4

• Returnspatientstotheirpreviouslevelsofactivity4

• Quantifiablediscmaterialremoval4

• Lessepiduralscarring

• Noovernighthospitalstay

• Quickrecoverytime

• Lowcomplicationandmorbidityrates7-15

Table 1.

Outcomes 6 Mo1 1 Year 4

PainReduction 60% 65%

AnalgesicReduction 74% 79%

FunctionalImprovement 90% 91%

OverallSatisfaction 80% 88%

Multiple clinical studies have shown that percutaneous

discectomy using the Stryker Dekompressor is successful

for90%ofpatients.4 This minimally invasive procedure

reduces pressure on the nerve root by removing disc

nucleus. It results in minimal annular disruption, preserving

disc strength and future treatment options, including

surgery.1,5,6 Recovery time is rapid, generally 3 to 5 days.

Stryker Disc Decompression is typically performed on an

outpatient basis and requires only local anesthetic and

mild sedation, alleviating the expense and possible

complications of open surgery and general anesthesia.

It typically takes only 15 to 30 minutes to perform and

doesn’t require a hospital stay.

Quick relief. Simple procedure.

Bulging/Herniated Disc Dekompressor needle is guided into the herniated disc, behind the nerve.

Aspiration of disc material using the

Dekompressor.

Decompressed disc.

9" Dekompressor

6" Dekompressor

3" Dekompressor

Image 2. Stryker Dekompressor

removes a measurable amount of

disc material without annular or

nuclear disruption.1,4,5,6

Image 1. MRI image of a

disc herniation.

Dekom

pre

ssor

Dekompressor

Documents

Transcript of Dekompressor