Your single source for VCF solutions. - · PDF fileFrom our new iVAS Inßatable Vertebral Augmentation System to our ... Your single source for VCF solutions. 1958 Simplex C Bone Cement

StrykerIVS.com

Stryker Interventional Spine.

Your single source for VCF solutions.

Osteoporotic fractures are a serious and growing problem for older adults and the healthcare system. In fact, one in two women and one in four men will have an osteoporotic fracture during their lifetime.1 Vertebral compression fractures (VCFs) are the most common with an estimated 700,000 such fractures reported each year.2, 3

Relieving pain. Improving lives.

With the addition of Cortoss Bone Augmentation Material, Stryker offers you a broad portfolio of products for VCF treatments. From our new iVAS Inflatable Vertebral Augmentation System to our mixer and delivery systems, cements, and needles, our unprecedented portfolio of products lets you customize your treatment approach. In fact, Stryker’s product configurations offer more flexibility, which helps contain costs and avoid waste.

The benefit of choice. The advantage of Stryker.

Needle is guided into fractured vertebra using fluoroscopy

Vertebroplasty involves injection of bone cement or bioactive composite15,16 directly into a fractured vertebral body from a percutaneous approach. The hardened cement or bioactive composite15,16 stabilizes the fracture, relieving pain.4,5

Vertebral augmentation is a treatment option for vertebral compression fractures that creates a void in the cancellous bone by way of an inflated balloon. This procedure helps ensure controlled and contained cement delivery into the factured vertebral body. Clinical results for both procedures show substantial pain relief 2,6 in approximately 90% of patients6 and potentially a significant increase in quality of life.2,7

The balloon is inflated, compacting the trabeculae and creating a cavity

Balloon catheter is inserted into the fractured vertebra

Vertebral Augmentation

Once the balloon is deflated and withdrawn, the cavity is filled with bone cement

Stabilized vertebral body

Vertebroplasty

Bone cement or bioactive composite is injected


Every spine is unique. Now your treatment options are too.

Vertebral compression fracture is identified

Hand drill is inserted into the anterior third of the vertebral body to create a pathway

Needle is guided into fractured vertebra using fluoroscopy

Cortoss Bone Augmentation MaterialCortoss is an injectable, non-resorbable composite consisting of cross-linking resins and reinforcing glass ceramic particles. It has been clinically proven to meet the safety and effectiveness of Polymethylmethacrylate (PMMA) for vertebral augmentation. Cortoss material properties create flow characteristics and fill patterns that may improve procedural safety and control.

FeaturesFlow and Fill: Properties improve short-term pain and long-term function15

Safety: Low incidence of adjacent fractures*15; minimal exotherm17 and monomer release18

Control: Procedural flexibility with mix-on-demand and start/stop delivery19

Data: Robust compilation of clinical data19

* In patients with one level treated and no previous fracture.

Stryker Bioactive Composite

1992

Orthovita founded

1997-1999

Cortoss development - a bioactive glass filled composite16

2002

US IDE Pilot Study: Vertebroplasty

2003

CE Mark Vertebral Augmentation

US IDE Pilot Study: Kyphoplasty

2004

US IDE Pivotal Study: Vertebroplasty

2009

FDA Cleared: Vertebral Augmentation

2011

Stryker acquired Orthovita

International Multi-Center Clinical Trials

Clinical testing provides the proof.15

The safety and efficacy of Cortoss have been demonstrated in an extensive multi-centre clinical study involving three U.S. and multiple European centres15

30% less material was required during vertebroplasty to achieve desired fill patterns15

In patients with a first-time fracture at one level, there was a 43% reduction in adjacent level fractures in the Cortoss patient population15

Axial View Coronal View Sagittal View

Aliquot Delivery System

Stryker Aliquot Accessories

Ordering Information

With mix-on-demand, working time is no longer a concern.

The Cortoss pastes are contained in a ready-to-use dual chamber cartridge

Material preparation is an on-demand process that takes seconds to complete

The concern of “working time” is irrelevant with Cortoss as fresh material is available as the need arises

Cortoss

2101-0002 Cortoss Cartridge, 5cc


2110-0008 Mixing and Delivery Gun

2110-0027 Mixing and Delivery Gun (Reusable)

2110-0031 Mix-Tips, Leur (qty 3)

Syringe Delivery System Kit

2090-0501 Syringe Delivery System, 4" Includes: 11g 4" Bevel Tip needle, 11g 4" Diamond Tip needle, 13g 6" Reamer, 13g 6" Catheter (qty 5), Side-port syringe (qty 5)

Plunger Delivery System Kit

2090-0502 Plunger Delivery System, 4" Includes: 11g 4" Bevel Tip needle, 11g 4" Diamond Tip needle, 13g 6" Reamer, 13g 6" Catheter (qty 5), 13g 6" Plunger (qty 5)

Ordering Information, continued

Intuitive injection control is fundamental to start/stop delivery.

Procedural flexibility if leaks are detected

Procedural control if needle repositioning is required

Control of operative workflow

Start and stop delivery as required until treatment goals are achieved

Aliquot Delivery System

2110-0505 11g 4" (10cm) Bevel Tip needle

2110-0506 13g 4" (10cm) Diamond Tip needle

2110-0501 13g 6" (15cm) Plunger

2110-0503 13g 6’’ (15cm) Catheter

2110-0507 Flexible Extension

2110-0513 Side Loading Syringe

As one of the world’s leading manufacturers of bone cement, Stryker continues to set the industry standard by providing physicians with a range of bone

cements that address specific viscosity and working time preferences for the treatment of vertebral compression fractures.

Stryker’s three unique VCF bone cements, compared at right, are indicated for use with percutaneous vertebroplasty and kyphoplasty,

providing the flexibility you want and the options you need for individualized patient care.

Once a benchmark, always a benchmark.

Stryker PMMA Bone Cements

Over the last three and a half decades, Stryker has implanted more than 23 million doses of bone cement. This expertise is grounded in Stryker’s Simplex P Bone Cement. In 1971, Simplex P became the first surgical bone cement approved by the FDA for total hip replacement. For more than 40 years, tens of thousands of physicians have trusted Stryker bone cements derived from Simplex P including SpinePlex, VertaPlex, and now VertaPlex HV.

Stryker Interventional Spine.Your single source for VCF solutions.

1958

Simplex C Bone Cement introduced in Europe

1962

Simplex P Bone Cement introduced in Europe

1971

Simplex P first to receive FDA approval in the U.S. for total hip arthroplasty

1973

Simplex P Bone Cement approved for total knee arthroplasty

1975

Simplex antibiotic Bone Cement (with Erythromycin and Colistin) introducedin Europe

1976

Simplex P approvedfor pathological fractures and general prosthetic fixation

1999

Over 15 million doses of Simplex P have been implanted

2000

Simplex P with Tobramycinintroduced in Europe

2003

Simplex P with Tobramycinintroduced in U.S.

SpinePlex introducedin Europe

2004

SpinePlex introduced in U.S.and used in thousands of VCF cases worldwide

2008

VertaPlex introduced worldwide

2010

VertaPlex HV introduced worldwide

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Graph 1. Independent lab results from Fluid Dynamics, Inc. commissioned by Stryker, Inc. July 2009. Testing conducted at 20-21˚C (68-70˚F).

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Stryker PMMA Bone Cement Viscosity

VertaPlex HV Ready when you are.

VertaPlex HV is a high viscosity bone cement that contributes to improved visibility and control. VertaPlex HV reaches a thick viscosity as soon as it’s mixed and maintains its viscous state for an average of 18 minutes.

FeaturesImmediate high viscosity after mixing

Controlled interdigitation and fill

Working time – approximately 18 minutes

Set time of 10.2 minutes at 37ºC

Lower creep rate

Increased viscosity improves visibility

30% barium sulfate concentration

Stryker PMMA Bone Cements


0507-589-000 (Sterile; 2 per box) VertaPlex HV / PCD System Kit with Straight Short Extension Tube and without Needles Includes: One-half dose of VertaPlex HV bone cement, one PCD mixer and delivery system with straight short extension tube

0607-687-000 (Sterile; 2 per box) AutoPlex System Kit with VertaPlex HV without Needles Includes: One -half dose of VertaPlex HV bone cement, one AutoPlex mixer and delivery system

A là carte

0406-222-000 (Sterile; 2 per box) SpinePlex 20 Gram Twin Pack (One-half Dose

0406-422-000 (Sterile; 2 per box) VertaPlex 20 Gram Twin Pack (One-half Dose)

0406-622-000 (Sterile; 2 per box) VertaPlex HV 20 Gram Twin Pack (One-half Dose)

VertaPlexExtended working time.

Developed for physicians who want lower initial viscosity and longer working time. Advantageous for multiple level vertebroplasties and kyphoplasties, VertaPlex maintains its toothpaste-like consistency for an average of 20 minutes.

FeaturesIncreased working time – approximately 20 minutes

Set time of 10.2 minutes at 37ºC

Low creep rate

30% barium sulfate concentration

SpinePlexProven performance.

SpinePlex is a derivative of Simplex P Bone Cement – the first surgical bone cement approved by the FDA, the first antibiotic-laden bone cement approved by the FDA,8 and the most widely used bone cement in the world.9 SpinePlex contains the same polymethylmethacrylate (PMMA) and is manufactured using the same proprietary process.

Features

minutes at 37ºC

concentration

VertaPlex HV VertaPlex SpinePlex

Recommended Companion Products

iVAS: Inflatable Vertebral Augmentation SystemThe iVAS Inflatable Vertebral Augmentation System is your complete solution for treating VCFs with kyphoplasty. During a kyphoplasty, a balloon catheter is used to create a void in a collapsed vertebra, helping to allow for controlled and contained cement delivery.2,11 Clinical results for kyphoplasty show the potential for substantial pain relief,13 increased mobility, and improved quality of life.2,5,6,7,10,11,12

Simple. Certain. Defined. iVAS measures up to your expectations and your expertise.

Stryker Vertebral Augmentation

iVAS System Kits

All the kits include: Balloon catheter, access cannula with diamond tip stylet, bevel tip stylet, locking syringe, stopcock (Sterile; 3 per box)

0705-210-000 10g iVAS System Kit (10 mm)




0705-815-000 8g iVAS System kit (15 mm)

0705-720-000 8g iVAS System kit (20 mm)

iVAS à la carte

0705-220-500 (Sterile; 3 per box) 20 mm iVAS Balloon à la carte



Supplemental

0306-808-000 (Sterile; 6 per box) 8g Hand Drill

0306-310-000 (Sterile; 18 per box) 8g VertePort Cement Cannulae

0306-125-000 8g Bone Biopsy Kit

0306-810-000 (Sterile; 6 per box) 10g Hand Drill

0306-410-000 (Sterile; 18 per box) 10g VertePort Cement Cannulae

0306-105-000 (Sterile; 6 per box) 10g Bone Biopsy Kit


AutoPlex

PCD

VertePort

All PMMA Cements

Bone Biopsy Kit


The balloon is inflated, compacting the trabeculae and creating a cavity

Once the balloon is deflated and withdrawn, the cavity is filled with bone cement


Procedure Overview

Bipedicular Kyphoplasty

Unipedicular Kyphoplasty

Balloon CatheterStiff distal balloon catheter provides rigidity for smooth insertion

Flexible proximal catheter allows for easy maneuverability

The radiopaque markers on the balloon catheter help facilitate accurate visualization and placement of the balloon

Access Cannula / StyletThe hand drill cuts cleanly through cancellous bone to create a channel for balloon placement

Graduation markings on the access cannula assist in measuring needle depth

Specifications

Inflated Balloon Dimensions (as tested in water at 37°C)

(10 mm) (15 mm) (2-20 mm)

Volume: 2 mL 4 mL 2 mL 4 mL 5 mL 2 mL 4 mL 6 mL

Length (L): 15.1 mm 21.1 mm 16.7 mm 24.0 mm 27.0 mm 19.0 mm 24.6 mm 29.3 mm

Diameter (D): 11.6 mm 15.5 mm 10.9 mm 14.9 mm 16.0 mm 10.8 mm 16.0 mm 18.3 mm

Maximum Balloon Inflation Values

Volume: 4 mL 5 mL 6 mL

Pressure: 400 psi [27 atm] 400 psi [27 atm] 400 psi [27 atm]

Stryker Mixer & Delivery Systems

AutoPlex

Mixer & Delivery SystemAutoPlex is a fast and easy-to-use mixer and delivery system. With the press of a single button, it mixes, transfers, and primes (ready to inject) highly viscous bone cement for delivery in less than 60 seconds.

Mixing

in less than 60 seconds, streamlining procedure time


0605-887-000 (Sterile; 2 per box) AutoPlex System Kit without Cement or Needles Includes: One AutoPlex mixer and delivery system

0607-687-000 (Sterile; 2 per box) AutoPlex System Kit with VertaPlex HV without Needles Includes: One -half dose of VertaPlex HV bone cement, one AutoPlex mixer and delivery system


iVAS

�� SpinePlex

�� VertaPlex

�� VertaPlex HV

�� VertePort

�� Cement Cannulae

Delivery

prevents exposure to harmful fumes

totaling 16" in length, helps ensure radiation safety

Attach extension tube to delivery cartridge, pour powder and then liquid monomer through supplied funnel

Lock lid onto mixing chamber

Press and release mixing button

Detach tube from cement injector when mixing/trans-fer are complete

Remove cement injector from mixing unit

Procedure Overview

PCD: Precision Cement Delivery An all-in-one mixer and delivery system, PCD offers ease of use, desired cement consistency, and helps improve procedure efficiency.

Mixing

Delivery

0.4 cc per full turn of delivery base

safety with more than 14" in total length

Stryker Mixer & Delivery Systems


0506-482-000 (Sterile; 4 per box) 10g PCD System Kit without Cement Includes: One PCD mixer and delivery system, one 10g 5" diamond tip match-ground introduction needle, one 10g 5" interchangeable bevel stylet



0506-486-000 (Sterile; 4 per box) PCD System Kit without Cement or Needles Includes: One PCD mixer and delivery system

0506-489-000 (Sterile; 4 per box) PCD System Kit with Straight Short Extension Tube and without Cement or Needles Includes: One PCD mixer and delivery system with straight short extension tube

iVAS

VertaPlex HV (short tube only)

VertaPlex

SpinePlex (one-half dose)

VertePort


VertaPlex HV only compatible with short tube.

Pour powder and monomer into funnel

Attach mixing blade and lock into place

Mix cement in an up and down motion while rotating the mixing handle

Remove hand mixer: push grey button inward, rotate clockwise, then pull handle straight up and out of mix chamber

Transfer and prime system by turning the base of the mixing chamber clockwise

Lock the delivery cartridge with the extension tube attached onto the mixing chamber by rotating counter-clockwise

Procedure Overview

Vertebral Bone Biopsy KitThe Stryker Bone Biopsy Kit is compatible with our standard 10, 11, and 13 gauge 5" needles, as well as 10 gauge 9" needles. The coaxial design allows for biopsy collection of a core sample within the vertebral body. This streamlined technique can be used in conjunction with VCF procedures or independent biopsies.

Features

image of bony landmarks and precise needle placement

Stryker VCF Accessories


0306-125-000: (Sterile; 6 per box) 8g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet

0306-105-000 (Sterile; 6 per box) 10g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet




All PMMA Cements

All Mixers and Delivery Systems

10g 5" Diamond Tip Match-Ground Introduction Needles





NeedlesStryker’s needles help offer optimal control and maneuverability in accessing the vertebral body and delivering bone cement during VCF treatments. The easy-to-introduce match-ground diamond tips are sharp and efficient in cutting bone, while the beveled stylets are useful for changing the tip direction according to which way the bevel is oriented.14

Features

reducing tissue ‘catching’ when introduced

with cannulae

under fluoroscopy

These needles are recommended only for Vertebroplasty procedures. VertePort needles are optimal for Kyphoplasty.


0306-100-000 (Sterile; 6 per box) 10g 5" Diamond Tip Match-Ground Introduction Needle

0306-101-000 (Sterile; 6 per box) 10g 5" Bevel Tip Match-Ground Introduction Needle



0306-114-000 (Sterile; 6 per box) 11g 4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet



0306-134-000 (Sterile; 6 per box) 13g 4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet



AutoPlex

PCD

VertePort

All PMMA Cements

Bone Biopsy Kit


VertePort Coaxial SystemVertePort is a coaxial, hollow-needle access system developed specifically for vertebral augmentation. The system offers multiple ways to deliver bone cement during VCF treatments.

By providing continuous access to the vertebral body, VertePort increases control while delivering cement with the use of a traditional injector.

If used to hand obturate cement delivery, VertePort’s mechanical advantage allows for delivery of thicker cement and increased working time compared to traditional injectors and syringes.

Stryker VCF Accessories

0306-110-000 (Sterile; 6 per box) 11g 5" Short Stylet Access Cannula

0306-400-000 (Sterile; 6 per box) 10g 5.75" Long Stylet Access Cannula

0306-530-000 (Sterile; 6 per box) 10g 5" Lubricated Access Needle

0306-080-000: (Sterile; 6 per box) 8g" Stylet Access Cannula diamond tip

0306-081-000: (Sterile; 6 per box) 8g" Stylet Access Cannula bevel tip

0306-510-000 (Sterile; 18 per box) 11g Cement Cannula




iVAS

AutoPlex

PCD

All PMMA Cements

Bone Biopsy Kit

10g and 11g Needles


Features

VCF treatment

unobstructed access to the vertebral body

viscosity bone cement

through hand obturation and/or traditional injector

with use of hand obturation

Filling of cement cannula using PCDCoaxial delivery of cement with VertePort Hand obturation

Approach Overview

Cortoss Bone Augmentation Material2101-0002 Cortoss Cartridge, 5cc


2110-0008 Mixing and Delivery Gun (Sterile)

2110-0027 Mixing and Delivery Gun (Resuable)

2110-0031 Mix-Tips, Leur (qty 3)

Syringe Delivery System Kit2090-0501 Syringe Delivery System, 4” Includes: 11g 4” Bevel Tip needle, 11g 4” Diamond Tip needle, 13g 6” Reamer, 13g 6” Catheter (qty 5), Side-port syringe (qty 5)

Plunger Delivery System Kit2090-0502 Plunger Delivery System, 4” Includes: 11g 4” Bevel Tip needle, 11g 4” Diamond Tip needle, 13g 6” Reamer, 13g 6” Catheter (qty 5), 13g 6” Plunger (qty 5)

Aliquot Delivery System2110-0505 11g 4" (10cm) Bevel Tip Needle

2110-0506 11g 4" (10cm) Diamond Tip Needle

2110-0501 13g 6" (15cm) Plunger

2110-0503 13g 6’’ (15cm) Catheter

2110-0507 Flexible Extension

2110-0513 Side Loading Syringe

PMMA Bone Cements

VertaPlex HV (Sterile; 2 per box)

0406-622-222 VertaPlex HV 20 Gram Twin Pack (one-half dose)

VertaPlex (Sterile; 2 per box)

0406-422-000 VertaPlex 20 Gram Twin Pack (one-half dose)

SpinePlex (Sterile; 2 per box)

0406-222-000 SpinePlex 20 Gram Twin Pack (one-half dose)

iVAS Inflatable Vertebral Augmentation System

All the kits include: Balloon catheter, access cannula with diamond tip stylet and bevel tip stylet, locking syringe, stopcock

0705-210-000 10g iVAS System Kit (Sterile; 3 per box) (10 mm)






iVAS à la Carte0705-120-500 iVAS Balloon Catheter (Sterile; 3 per box) (10 mm)

0705-115-500 iVAS Balloon Catheter (Sterile; 3 per box) (15 mm)

0705-220-500 iVAS Balloon Catheter (Sterile; 3 per box) (20 mm)

0306-810-000 10g Hand Drill (Sterile; 6 per box)

0306-808-000 8g Hand Drill (Sterile; 6 per box)

Mixers and Delivery Systems

AutoPlex (Sterile; 2 per box)

0605-887-000 AutoPlex System Kit without Cement or Needles Includes: One AutoPlex mixer and delivery system

0607-687-000 AutoPlex System Kit with VertaPlex HV without Needles Includes: One-half dose of VertaPlex HV bone cement, one AutoPlex mixer and delivery system

PCD (Sterile; 4 per box)

0506-482-000 10g PCD System Kit Includes: One PCD mixer and delivery system, one 10g 5" diamond tip match-ground introduction needle, one 10g 5" interchangeable bevel stylet



0506-486-000 PCD System Kit without Needles Includes: One PCD mixer and delivery system

0506-489-000 PCD System Kit with Straight Short Extension Tube and without Needles Includes: One PCD mixer and delivery system with straight short extension tube

0507-589-000 VertaPlex HV / PCD System Kit with Straight Short Extension Tube and without Needles Includes: One half dose of VertaPlex HV Bone Cement, one PCD mixer and delivery system with straight short extension tube

VertePort

Access Cannulae for Kyphoplasty (Sterile; 6 per box)

0306-400-000 10g 5.75" Long Stylet Access Cannula

0306-080-000 8g 5" Access Needle (Diamond tip)

0306-081-000 8g 5" Access Needle (Bevel tip)

0306-530-000 10g 5" Lubricated Access Needle

0306-110-000 11g 5" Diamond Tip Match-Ground Introduction Needle

Cement Cannulae (Sterile; 18 per box)

0306-510-000 11g Cement Cannula (for use with 11g 5" access needle 0306-110-000)

0306-410-000 10g Cement Cannula (for use with 10g long and short access needles)

0306-310-000 8g Cement Cannula (for use with 8g long and short access needles)

Needles for Vertebroplasty (Sterile; 6 per box)

10g 0306-100-000 10g 5" Diamond Tip Match-Ground Introduction Needle

0306-101-000 10g 5" Bevel Tip Match-Ground Introduction Needle



11g 0306-110-000 11g 5" Diamond Tip Match-Ground Introduction Needle


0306-114-000 11g 4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet

13g 0306-134-000 13g 4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet



14g 0306-140-000 14 g 4.4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet

Bone Biopsy Kits (Sterile; 6 per box)

0306-105-000 10g 5" Bone Biopsy Kit

0306-125-000 8g 5” Bone Biopsy Kit




NOTES

Footnotes1. National Osteoporosis Foundation. Disease facts. Available at: www.nof.org/ osteoporosis/diseasefacts.htm.

Accessed September 11, 20092. Siemionow, K and Lieberman, IH. Vertebral Augmentation in Osteoporotic and Osteolytic Fractures. Current

Opinion in Supportive and Palliative Care. 2009 Sept 3:219-2253. http://www.orthosupersite.com/view.asp?rID=1702 accessed Sept. 11, 20094. Lovi A, Teli M, Ortolina A, et al. Vertebroplasty and Kyphoplasty: Complementary Techniques for the Treatment of

Painful Osteoporotic Vertebral Compression Fractures. A Prospective Non-randomised Study on 154 Patients Eur Spine Jour (2009) 18 (Suppl 1):S95-S101

5. Passias PG, Li Gang, Wood, KB. SRS Position Paper: The Results of Vertebral Augmentation Procedures Department of Orthopaedic Spine Surgery Massachusetts General Hospital and Harvard Medical School Boston, MA Sept. 8, 2008

6. Lavelle W, Carl A, Lavelle ED, Khaleel MA. Vertebroplasty and Kyphoplasty, Anesthesiol Clin. 2007 Dec;25 (4):913-28

7. McKiernan F, Faciszewski T, Jensen R. Quality Of Life Following Vertebroplasty. J Bone Joint Surg Am. 2004 Dec;86-A(12):2600-6

8. The Worldwide Orthopaedic Market. Prepared by Knowledge Enterprises. October 2005, p. 119. Orthopaedic Industry Annual Report: 2008-2009. Orthoworld, Inc. 2009, p. 2210. Kochan, J. Vertebroplasty and Kyphoplasty, Percutaneous. http://emedicine.medscape.com/article/423209-

overview Accessed September 1, 2009. 11. Wardlaw, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P,Talmadge

K, Boonen S. Efficacy and Safety of Balloon Kyphoplasty Compared with Non-surgical Care for Vertebral Compression Fracture (FREE): a Randomized Controlled Trial www.thelancet.com Published online February 25, 2009 DOI:10.1016/S0140-6736(09)60010-6

12. Jensen ME, McGraw JK, Cardella JF, Hirsch JA. Position statement on percutaneous vertebral augmentation: A consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. J Vasc Interv Radiol 2009; 20:S326–S331

13. Eck JC, Nachtigall D, Humphreys SC, Hodges SD. Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature. The Spine Journal 2008; 8:488-497

14. Percutaneous Vertebroplasty and Kyphoplasty – Ed. 2 / Editors, John M Mathis, Hervé Deramond, Stephen M. Belkoff. Copyright 2006 by Springer Science+Business Media, Inc., p. 118

15. Bae, H., et al, A Prospective Randomized FDA-IDE Trial Comparing Cortoss to PMMA for Vertebroplasty: A Comparative Effectiveness Research Study with 24-Months Follow-Up. Spine, first published on July 5, 2011 as doi: 10.1097/BRS.0b013e31822ba50b.

16. The bioactive response of Cortoss has not been assessed in any clinical investigation and the results from laboratory or animal testing may not be predictive of human clinical experience.

17. Deramond H, Wright NT, Belko- SM. Temperature elevation caused by bone cement polymerization during vertebroplasty. Bone, 1999. Vol 25 (2) 17S-21S.

18. 5. Pomrink, et al., Evaluation of the reaction kinetics of Cortoss, a thermoset cortical bone void ller. Biomaterials, 2003, Vol. 24 (6) 1023-1031.

19. Cortoss Bone Augmentation Material: Instructions for Use (IFU))

* Information current as of June 2012

This document is intended solely for the use of healthcare professionals.

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product.

Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Stryker, AutoPlex, VertePort, VertaPlex, SpinePlex, iVAS, PCD. All other trademarks are trademarks of their respective owners or holders.

The products listed above are CE marked according to the Medical Device Directive 93/42/EEC.

Literature Number: MTX1000025036 Rev CMTX/GS 06/12

Copyright © 2012 Stryker

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Your single source for VCF solutions. - · PDF fileFrom our new iVAS Inßatable Vertebral Augmentation System to our ... Your single source for VCF solutions. 1958 Simplex C Bone Cement