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Transcript of Your single source for VCF solutions. - · PDF fileFrom our new iVAS Inßatable Vertebral...
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Once the balloon is deflated and withdrawn, the cavity is filled with bone cement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
Stabilized vertebral body
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
2101-0000 Cortoss Cartridge, 10cc
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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VertaPlex HV
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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
Ordering Information
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)
0705-115-000 10g iVAS System Kit (15 mm)
0705-220-000 10g iVAS System Kit (20 mm)
0705-710-000 8g 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
0705-115-500 (Sterile; 3 per box) 15 mm iVAS Balloon à la carte
0705-210-500 (Sterile; 3 per box) 10 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
Ordering Information
AutoPlex
PCD
VertePort
All PMMA Cements
Bone Biopsy Kit
Recommended Companion Products
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
Stabilized vertebral body
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
Ordering Information
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
Recommended Companion Products
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
Ordering Information
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
0506-483-000 (Sterile; 4 per box) 11g PCD System Kit without Cement Includes: One PCD mixer and delivery system, one 11g 5" diamond tip match-ground introduction needle, one 11g 5" interchangeable bevel stylet
0506-485-000 (Sterile; 4 per box) 13g PCD System Kit without Cement Includes: One PCD mixer and delivery system, one 13g 5" diamond tip match-ground introduction needle, one 13g 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
Recommended Companion Products
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
Ordering Information
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
0306-195-000 (Sterile; 6 per box) 10g 9" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet
0306-115-000 (Sterile; 6 per box) 11g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet
0306-135-000 (Sterile; 6 per box) 13g 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
10g 9" Diamond Tip Match-Ground Introduction Needles
11g 5" Diamond Tip Match-Ground Introduction Needles
13g 5" Diamond Tip Match-Ground Introduction Needles
Recommended Companion Products
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.
Ordering Information
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
0306-190-000 (Sterile; 6 per box) 10g 9" Diamond Tip Match-Ground Introduction Needle
0306-191-000 (Sterile; 6 per box) 10g 9" Bevel Tip Match-Ground Introduction Needle
0306-114-000 (Sterile; 6 per box) 11g 4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet
0306-110-000 (Sterile; 6 per box) 11g 5" Diamond Tip Match-Ground Introduction Needle
0306-111-000 (Sterile; 6 per box) 11g 5" Bevel Tip Match-Ground Introduction Needle
0306-134-000 (Sterile; 6 per box) 13g 4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet
0306-130-000 (Sterile; 6 per box) 13g 5" Diamond Tip Match-Ground Introduction Needle
0306-131-000 (Sterile; 6 per box) 13g 5" Bevel Tip Match-Ground Introduction Needle
AutoPlex
PCD
VertePort
All PMMA Cements
Bone Biopsy Kit
Recommended Companion Products
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
0306-410-000 (Sterile; 18 per box) 10g Cement Cannula
0306-310-000 (Sterile; 18 per box) 8g Cement Cannula
Recommended Companion Products
iVAS
AutoPlex
PCD
All PMMA Cements
Bone Biopsy Kit
10g and 11g Needles
Ordering Information
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
2101-0000 Cortoss Cartridge, 10cc
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)
0705-115-000 10g iVAS System Kit (Sterile; 3 per box) (15 mm)
0705-220-000 10g iVAS System Kit (Sterile; 3 per box) (20 mm)
0705-710-000 8g iVAS System Kit (Sterile; 3 per box) (10 mm)
0705-815-000 8g iVAS System Kit (Sterile; 3 per box) (15 mm)
0705-720-000 8g iVAS System Kit (Sterile; 3 per box) (20 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
0506-483-000 11g PCD System Kit Includes: One PCD mixer and delivery system, one 11g 5" diamond tip match-ground introduction needle, one 11g 5" interchangeable bevel stylet
0506-485-000 13g PCD System Kit Includes: One PCD mixer and delivery system, one 13g 5" diamond tip match-ground introduction needle, one 13g 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
0306-190-000 10g 9" Diamond Tip Match-Ground Introduction Needle
0306-191-000 10g 9" Bevel Tip Match-Ground Introduction Needle
11g 0306-110-000 11g 5" Diamond Tip Match-Ground Introduction Needle
0306-111-000 11g 5" Bevel 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
0306-130-000 13g 5" Diamond Tip Match-Ground Introduction Needle
0306-131-000 13g 5" Bevel Tip Match-Ground Introduction Needle
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
0306-195-000 10g 9" Bone Biopsy Kit
0306-115-000 11g 5" Bone Biopsy Kit
0306-135-000 13g 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.
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The products listed above are CE marked according to the Medical Device Directive 93/42/EEC.
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