Stryker Interventional Spine. Your single source for VCF solutions.
StrykerIVS.com The benefit of choice. The advantage of Stryker.
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. Every spine is unique. Now your treatment options are too.
Vertebroplasty involves injection Vertebroplasty Vertebral Augmentation 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 compression fracture Needle is guided into fractured Vertebral augmentation is is identified vertebra using fluoroscopy 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 Needle is guided into fractured Hand drill is inserted into the anterior third the factured vertebral body. vertebra using fluoroscopy of the vertebral body to create a pathway
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 Bone cement or bioactive composite Balloon catheter is inserted is injected into the fractured vertebra
Stabilized vertebral body 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Once the balloon is deflated and withdrawn, the cavity is filled with bone cement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 Stryker Bioactive Composite Cortoss Bone Augmentation Material
Cortoss 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.
Features s Flow and Fill: Properties improve short-term pain and long-term function15 s Safety: Low incidence of adjacent fractures*15; minimal exotherm17 and monomer release18 s Control: Procedural flexibility with mix-on-demand and start/stop delivery19 s Data: Robust compilation of clinical data19
* In patients with one level treated and no previous fracture.
1992 1997-1999 2002 2003 2004 2009 2011
Orthovita founded Cortoss US IDE Pilot Study: CE Mark US IDE FDA Cleared: Stryker acquired development - a Vertebroplasty Vertebral Pivotal Study: Vertebral Orthovita bioactive glass Augmentation Vertebroplasty Augmentation 16 filled composite US IDE Pilot Study: Kyphoplasty International Multi-Center Clinical Trials Clinical testing provides the proof.15 s The safety and efficacy of Cortoss have been demonstrated in an extensive multi-centre clinical study involving three U.S. and multiple European centres15 s 30% less material was required during vertebroplasty to achieve desired fill patterns15 s 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 Stryker Aliquot Accessories Aliquot Delivery System
With mix-on-demand, working time is no longer a concern. s The Cortoss pastes are contained in a ready-to- use dual chamber cartridge s Material preparation is an on-demand process that takes seconds to complete s The concern of “working time” is irrelevant with Cortoss as fresh material is available as the need arises
Ordering Information
Cortoss Syringe Delivery Plunger Delivery System Kit System Kit 2101-0002 Cortoss Cartridge, 5cc 2090-0501 2090-0502 Syringe Delivery System, 4" Plunger Delivery System, 4" 2101-0000 Includes: 11g 4" Bevel Tip needle, 11g Includes: 11g 4" Bevel Tip needle, 11g 4" Cortoss Cartridge, 10cc 4" Diamond Tip needle, 13g 6" Reamer, Diamond Tip needle, 13g 6" Reamer, 13g 6" 13g 6" Catheter (qty 5), Side-port syringe Catheter (qty 5), 13g 6" Plunger (qty 5) 2110-0008 (qty 5) Mixing and Delivery Gun 2110-0027 Mixing and Delivery Gun (Reusable) 2110-0031 Mix-Tips, Leur (qty 3) Intuitive injection control is fundamental to start/stop delivery. s Procedural flexibility if leaks are detected s Procedural control if needle repositioning is required s Control of operative workflow s Start and stop delivery as required until treatment goals are achieved
Ordering Information, continued
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 Stryker PMMA Bone Cements Once a benchmark, always a benchmark.
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.
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 1962 1971 1973 1975 1976
Simplex C Bone Simplex P Bone Simplex P first to Simplex P Bone Simplex antibiotic Simplex P approved Cement introduced Cement introduced receive FDA approval Cement approved Bone Cement (with for pathological in Europe in Europe in the U.S. for total for total knee Erythromycin and fractures and general hip arthroplasty arthroplasty Colistin) introduced prosthetic fixation in Europe Stryker PMMA Bone Cement Viscosity
VertaPlex HV
s) .
VertaPlex SpinePlex iscosity (in pa
V
Time (in minutes)
Graph 1. Independent lab 1000 results from Fluid Dynamics, Inc. commissioned by Stryker, Inc. 750 July 2009. Testing conducted at 20-21˚C (68-70˚F). 500 250
0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5
1999 2000 2003 2004 2008 2010
Over 15 million doses Simplex P Simplex P with SpinePlex VertaPlex introduced VertaPlex HV of Simplex P with Tobramycin Tobramycin introduced in U.S. worldwide introduced have been implanted introduced in Europe introduced in U.S. and used in worldwide thousands of VCF SpinePlex introduced cases worldwide in Europe Stryker PMMA Bone Cements 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.
Features s Immediate high viscosity after mixing s Controlled interdigitation and fill s Working time – approximately 18 minutes s Set time of 10.2 minutes at 37ºC s Lower creep rate s Increased viscosity improves visibility s 30% barium sulfate concentration
Ordering Information
0507-589-000 (Sterile; 2 per box) A là carte VertaPlex HV / PCD System Kit with Straight Short Extension Tube and 0406-222-000 (Sterile; 2 per box) without Needles SpinePlex 20 Gram Twin Pack (One-half Dose Includes: One-half dose of VertaPlex HV bone cement, one PCD mixer and delivery system 0406-422-000 (Sterile; 2 per box) with straight short extension tube VertaPlex 20 Gram Twin Pack (One-half Dose)
0607-687-000 (Sterile; 2 per box) 0406-622-000 (Sterile; 2 per box) AutoPlex System Kit with VertaPlex HV VertaPlex HV 20 Gram Twin Pack without Needles (One-half Dose) Includes: One -half dose of VertaPlex HV bone cement, one AutoPlex mixer and delivery system VertaPlex SpinePlex Extended working time. Proven performance.
Developed for physicians who want SpinePlex is a derivative of Simplex P Bone lower initial viscosity and longer working Cement – the first surgical bone cement approved time. Advantageous for multiple level by the FDA, the first antibiotic-laden bone cement vertebroplasties and kyphoplasties, VertaPlex approved by the FDA,8 and the most widely used maintains its toothpaste-like consistency for an bone cement in the world.9 SpinePlex contains average of 20 minutes. the same polymethylmethacrylate (PMMA) and is manufactured using the same proprietary process. Features s Increased working time – approximately 20 minutes Features s Set time of 10.2 minutes at 37ºC s $ERIVATIVE OF 3IMPLEX 0 "ONE #EMENT s Low creep rate s 7ORKING TIME OF MINUTES s 30% barium sulfate s 3ET TIME OF concentration minutes at 37ºC s BARIUM SULFATE concentration
Recommended Companion Products
VertaPlex HV VertaPlex SpinePlex s !UTO0LEX s !UTO0LEX s !UTO0LEX s 0#$ SHORT TUBE s 0#$ s 0#$ s 6ERTE0ORT s 6ERTE0ORT s 6ERTE0ORT s !LL .EEDLES #EMENT #ANNULAE s !LL .EEDLES #EMENT #ANNULAE s !LL .EEDLES #EMENT #ANNULAE Stryker Vertebral Augmentation iVAS: Inflatable Vertebral Augmentation System
The 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.
Ordering Information iVAS System Kits 0705-710-000 0705-115-500 0306-125-000 8g iVAS System Kit (Sterile; 3 per box) 8g Bone Biopsy Kit All the kits include: Balloon (10 mm) 15 mm iVAS Balloon à la carte catheter, access cannula with 0306-810-000 diamond tip stylet, bevel tip stylet, 0705-815-000 0705-210-500 (Sterile; 6 per box) locking syringe, stopcock 8g iVAS System kit (Sterile; 3 per box) 10g Hand Drill (Sterile; 3 per box) (15 mm) 10 mm iVAS Balloon à la carte 0306-410-000 0705-210-000 0705-720-000 Supplemental (Sterile; 18 per box) 10g iVAS System Kit 8g iVAS System kit 10g VertePort Cement Cannulae (10 mm) (20 mm) 0306-808-000 (Sterile; 6 per box) 0306-105-000 0705-115-000 iVAS à la carte 8g Hand Drill (Sterile; 6 per box) 10g iVAS System Kit 10g Bone Biopsy Kit (15 mm) 0705-220-500 0306-310-000 (Sterile; 3 per box) (Sterile; 18 per box) 0705-220-000 20 mm iVAS Balloon à la carte 8g VertePort Cement Cannulae 10g iVAS System Kit (20 mm) Balloon Catheter s Stiff distal balloon catheter provides rigidity for smooth insertion s Flexible proximal catheter allows for easy maneuverability s The radiopaque markers on the balloon catheter help facilitate accurate visualization and placement of the balloon
Access Cannula / Stylet s The hand drill cuts cleanly through cancellous bone to create a channel for balloon placement Unipedicular Kyphoplasty s 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 Bipedicular Kyphoplasty Volume: 4 mL 5 mL 6 mL Pressure: 400 psi [27 atm] 400 psi [27 atm] 400 psi [27 atm]
Recommended Procedure Overview Companion Products s AutoPlex s PCD s VertePort s All PMMA Cements s Bone Biopsy Kit
The balloon is inflated, Once the balloon is deflated Stabilized vertebral body compacting the trabeculae and withdrawn, the cavity is and creating a cavity filled with bone cement Stryker Mixer & Delivery Systems
AutoPlex Mixer & Delivery System
AutoPlex 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 s !UTOMATICALLY MIXES TRANSFERS PRIMES AND READIES CEMENT FOR DELIVERY in less than 60 seconds, streamlining procedure time s 0ROVIDES CONSISTENT AND THOROUGH MIXING ELIMINATING HUMAN ERROR AND VARIABILITY
Ordering Information Recommended Companion Products
0605-887-000 (Sterile; 2 per box) s iVAS VertaPlex HV AutoPlex System Kit without Cement SpinePlex VertePort or Needles Includes: One AutoPlex mixer and delivery VertaPlex !LL .EEDLES system Cement Cannulae 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 Delivery s ,IGHTWEIGHT ERGONOMIC DELIVERY INJECTOR s 0ROVIDES CC OF DELIVERABLE CEMENT s #LOSED MIXING TRANSFER AND DELIVERY SYSTEM prevents exposure to harmful fumes s &LEXIBLE EXTENSION TUBE AND DELIVERY CARTRIDGE totaling 16" in length, helps ensure radiation safety s %RGONOMIC LUER DESIGN s $ELIVERS CC PER FULL TURN s 3IMPLE AND RELIABLE HANDHELD INJECTION
Procedure Overview
Attach extension tube to delivery cartridge, Lock lid onto mixing Press and release Detach tube from Remove cement pour powder and then liquid monomer chamber mixing button cement injector injector from through supplied funnel when mixing/trans- mixing unit fer are complete Stryker Mixer & Delivery Systems 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 s -ANUALLY MIXES IN APPROXIMATELY ONE MINUTE s #LOSED VACUUM MIXING SYSTEM IS PROVEN TO ENHANCE THE CEMENTS CAPABILITIES s 3TREAMLINED TRANSFER OF MIXED CEMENT TO DELIVERY CARTRIDGE s -IXING BLADE CONSISTENTLY BLENDS CEMENT POWDER AND LIQUID TOGETHER TO FORM DESIRED VISCOSITY s h,OCK DOWNv LID AND CHARCOAL lLTER LOCK IN AND EVACUATE 0--! FUMES
Delivery s (AND OPERATED ALLOWING PRECISE DELIVERY OF MIXED CEMENT WITH 0.4 cc per full turn of delivery base s $ELIVERY CARTRIDGE AND EXTENSION TUBE PROVIDE RADIATION safety with more than 14" in total length s 0ROVIDES CC OF DELIVERABLE CEMENT
Ordering Information Recommended Companion Products
0506-482-000 (Sterile; 4 per box) 0506-485-000 (Sterile; 4 per box) s iVAS 10g PCD System Kit without Cement 13g PCD System Kit without Cement s VertaPlex HV (short tube only) Includes: One PCD mixer and delivery system, one Includes: One PCD mixer and delivery system, one 10g 5" diamond tip match-ground introduction 13g 5" diamond tip match-ground introduction s VertaPlex needle, one 10g 5" interchangeable bevel stylet needle, one 13g 5" interchangeable bevel stylet s SpinePlex (one-half dose) 0506-483-000 (Sterile; 4 per box) 0506-486-000 (Sterile; 4 per box) s VertePort 11g PCD System Kit without Cement PCD System Kit without Includes: One PCD mixer and delivery system, one Cement or Needles s !LL .EEDLES #EMENT #ANNULAE 11g 5" diamond tip match-ground introduction Includes: One PCD mixer and delivery system needle, one 11g 5" interchangeable bevel stylet 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
VertaPlex HV only compatible with short tube.
Procedure Overview
Pour powder and Attach mixing blade Mix cement in an up Remove hand Lock the delivery Transfer and prime monomer into funnel and lock into place and down motion mixer: push grey cartridge with the system by turning the while rotating the button inward, extension tube base of the mixing mixing handle rotate clockwise, attached onto the chamber clockwise then pull handle mixing chamber straight up and out by rotating counter- of mix chamber clockwise Stryker VCF Accessories Vertebral Bone Biopsy Kit
The 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 s 0RE PACKAGED IN AND GAUGE KITS s %ASY STREAMLINED APPROACH s %NABLES ACCESS FOR SUBSEQUENT PROCEDURES s 2ADIOLUCENT HANDLES ALLOW UNOBSTRUCTED image of bony landmarks and precise needle placement
Ordering Information Recommended Companion Products
0306-125-000: (Sterile; 6 per box) 0306-115-000 (Sterile; 6 per box) s All PMMA Cements 8g 5" Bone Biopsy Kit 11g 5" Bone Biopsy Kit s All Mixers and Delivery Systems Includes: Blunt tip, coaxial needle, inner stylet Includes: Blunt tip, coaxial needle, inner stylet s 10g 5" Diamond Tip Match-Ground 0306-105-000 (Sterile; 6 per box) 0306-135-000 (Sterile; 6 per box) Introduction Needles 10g 5" Bone Biopsy Kit 13g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet Includes: Blunt tip, coaxial needle, inner stylet s 10g 9" Diamond Tip Match-Ground Introduction Needles 0306-195-000 (Sterile; 6 per box) 10g 9" Bone Biopsy Kit s 11g 5" Diamond Tip Match-Ground Includes: Blunt tip, coaxial needle, inner stylet Introduction Needles s 13g 5" Diamond Tip Match-Ground Introduction Needles Needles
Stryker’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 s &OUR FACETED OUTER CANNULA IS GROUND DOWN TO MATCH STYLET reducing tissue ‘catching’ when introduced s $IAMOND AND BEVEL TIPPED STYLETS ARE INTERCHANGEABLE with cannulae s "EVEL MARKINGS INDICATE STEERING DIRECTION s 7IDE RANGE OF NEEDLE GAUGES AVAILABLE GAUGE s 2ADIOLUCENT HANDLES HELP PROVIDE CLEAR VISIBILITY under fluoroscopy
These needles are recommended only for Vertebroplasty procedures. VertePort needles are optimal for Kyphoplasty.
Ordering Information Recommended Companion Products
0306-100-000 (Sterile; 6 per box) 0306-110-000 (Sterile; 6 per box) s AutoPlex 10g 5" Diamond Tip Match-Ground 11g 5" Diamond Tip Match-Ground s PCD Introduction Needle Introduction Needle s VertePort 0306-101-000 (Sterile; 6 per box) 0306-111-000 (Sterile; 6 per box) 10g 5" Bevel Tip Match-Ground 11g 5" Bevel Tip Match-Ground s All PMMA Cements Introduction Needle Introduction Needle s Bone Biopsy Kit 0306-190-000 (Sterile; 6 per box) 0306-134-000 (Sterile; 6 per box) 10g 9" Diamond Tip Match-Ground 13g 4" Diamond Tip Match-Ground Introduction Needle Introduction Needle and Bevel Stylet
0306-191-000 (Sterile; 6 per box) 0306-130-000 (Sterile; 6 per box) 10g 9" Bevel Tip Match-Ground 13g 5" Diamond Tip Match-Ground Introduction Needle Introduction Needle
0306-114-000 (Sterile; 6 per box) 0306-131-000 (Sterile; 6 per box) 11g 4" Diamond Tip Match-Ground 13g 5" Bevel Tip Match-Ground Introduction Needle and Bevel Stylet Introduction Needle Stryker VCF Accessories VertePort Coaxial System
VertePort 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.
Ordering Information Recommended Companion Products 0306-110-000 (Sterile; 6 per box) 0306-410-000 (Sterile; 18 per box) 11g 5" Short Stylet Access Cannula 10g Cement Cannula s iVAS
0306-400-000 (Sterile; 6 per box) 0306-310-000 (Sterile; 18 per box) s AutoPlex 10g 5.75" Long Stylet Access Cannula 8g Cement Cannula s PCD 0306-530-000 (Sterile; 6 per box) s All PMMA Cements 10g 5" Lubricated Access Needle s Bone Biopsy Kit 0306-080-000: (Sterile; 6 per box) s 10g and 11g Needles 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 Features s %XCELLENT TACTILE FEEL s AND GAUGE OPTIONS s -AXIMIZES mEXIBILITY DURING VCF treatment s 0ROVIDES CONSTANT unobstructed access to the vertebral body s !LLOWS FOR EASY DELIVERY OF HIGH viscosity bone cement s 0RECISE CONTROL s !BILITY TO DELIVER CEMENT through hand obturation and/or traditional injector s %XTENDS CEMENT WORKING TIME with use of hand obturation
Approach Overview
Coaxial delivery of cement with VertePort Filling of cement cannula using PCD Hand obturation 0506-483-000 Cortoss Bone iVAS 11g PCD System Kit Inflatable Vertebral Augmentation System Includes: One PCD mixer and delivery Augmentation Material system, one 11g 5" diamond tip match- All the kits include: Balloon catheter, access ground introduction needle, one 11g 5" 2101-0002 cannula with diamond tip stylet and bevel tip interchangeable bevel stylet Cortoss Cartridge, 5cc stylet, locking syringe, stopcock 0506-485-000 2101-0000 0705-210-000 13g PCD System Kit Cortoss Cartridge, 10cc 10g iVAS System Kit (Sterile; 3 per box) Includes: One PCD mixer and delivery (10 mm) system, one 13g 5" diamond tip match- 2110-0008 ground introduction needle, one 13g 5" Mixing and Delivery Gun (Sterile) 0705-115-000 interchangeable bevel stylet 10g iVAS System Kit (Sterile; 3 per box) 2110-0027 (15 mm) 0506-486-000 Mixing and Delivery Gun (Resuable) PCD System Kit without Needles 0705-220-000 Includes: One PCD mixer and delivery system 2110-0031 10g iVAS System Kit (Sterile; 3 per box) Mix-Tips, Leur (qty 3) (20 mm) 0506-489-000 PCD System Kit with Straight Short 0705-710-000 Extension Tube and without Needles Syringe Delivery System Kit 8g iVAS System Kit (Sterile; 3 per box) Includes: One PCD mixer and delivery system (10 mm) with straight short extension tube 2090-0501 Syringe Delivery System, 4” 0705-815-000 0507-589-000 Includes: 11g 4” Bevel Tip needle, 11g 4” 8g iVAS System Kit (Sterile; 3 per box) VertaPlex HV / PCD System Kit with Diamond Tip needle, 13g 6” Reamer, 13g 6” (15 mm) Straight Short Extension Tube and Catheter (qty 5), Side-port syringe (qty 5) without Needles 0705-720-000 Includes: One half dose of VertaPlex HV Bone 8g iVAS System Kit (Sterile; 3 per box) Cement, one PCD mixer and delivery system Plunger Delivery System Kit (20 mm) with straight short extension tube 2090-0502 Plunger Delivery System, 4” iVAS à la Carte VertePort Includes: 11g 4” Bevel Tip needle, 11g 4” Diamond Tip needle, 13g 6” Reamer, 13g 6” 0705-120-500 Catheter (qty 5), 13g 6” Plunger (qty 5) iVAS Balloon Catheter (Sterile; 3 per box) Access Cannulae for (10 mm) Kyphoplasty (Sterile; 6 per box) Aliquot Delivery System 0705-115-500 iVAS Balloon Catheter (Sterile; 3 per box) 0306-400-000 2110-0505 (15 mm) 10g 5.75" Long Stylet Access Cannula 11g 4" (10cm) Bevel Tip Needle 0705-220-500 0306-080-000 2110-0506 iVAS Balloon Catheter (Sterile; 3 per box) 8g 5" Access Needle (Diamond tip) 11g 4" (10cm) Diamond Tip Needle (20 mm) 0306-081-000 2110-0501 0306-810-000 8g 5" Access Needle (Bevel tip) 13g 6" (15cm) Plunger 10g Hand Drill (Sterile; 6 per box) 0306-530-000 2110-0503 0306-808-000 10g 5" Lubricated Access Needle 13g 6’’ (15cm) Catheter 8g Hand Drill (Sterile; 6 per box) 0306-110-000 2110-0507 11g 5" Diamond Tip Match-Ground Flexible Extension Mixers and Delivery Introduction Needle 2110-0513 Systems Side Loading Syringe Cement Cannulae (Sterile; 18 per box) AutoPlex (Sterile; 2 per box) 0306-510-000 11g Cement Cannula (for use with 0605-887-000 11g 5" access needle 0306-110-000) AutoPlex System Kit without PMMA Bone Cements Cement or Needles Includes: One AutoPlex mixer and 0306-410-000 10g Cement Cannula (for use with (Sterile; 2 per box) delivery system VertaPlex HV 10g long and short access needles) 0406-622-222 0607-687-000 0306-310-000 VertaPlex HV 20 Gram Twin Pack AutoPlex System Kit with VertaPlex HV 8g Cement Cannula (for use with 8g long and (one-half dose) without Needles Includes: One-half dose of VertaPlex HV bone short access needles) cement, one AutoPlex mixer and delivery VertaPlex (Sterile; 2 per box) system
0406-422-000 VertaPlex 20 Gram Twin Pack PCD (Sterile; 4 per box) (one-half dose) 0506-482-000 10g PCD System Kit SpinePlex (Sterile; 2 per box) Includes: One PCD mixer and delivery system, one 10g 5" diamond tip match- 0406-222-000 ground introduction needle, one 10g 5" SpinePlex 20 Gram Twin Pack interchangeable bevel stylet (one-half dose) Needles for NOTES 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 Reconstructive Hips
Footnotes Knees 1. National Osteoporosis Foundation. Disease facts. Available at: www.nof.org/ osteoporosis/diseasefacts.htm. Accessed September 11, 2009 Trauma & Extremities 2. Siemionow, K and Lieberman, IH. Vertebral Augmentation in Osteoporotic and Osteolytic Fractures. Current Joint Preservation Opinion in Supportive and Palliative Care. 2009 Sept 3:219-225 3. http://www.orthosupersite.com/view.asp?rID=1702 accessed Sept. 11, 2009 Orthobiologics 4. 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 Medical & Surgical Department of Orthopaedic Spine Surgery Massachusetts General Hospital and Harvard Medical School Boston, MA Sept. 8, 2008 Power Tools & Surgical Accessories 6. Lavelle W, Carl A, Lavelle ED, Khaleel MA. Vertebroplasty and Kyphoplasty, Anesthesiol Clin. 2007 Dec;25 (4):913- 28 Image Guided Navigation 7. McKiernan F, Faciszewski T, Jensen R. Quality Of Life Following Vertebroplasty. J Bone Joint Surg Am. 2004 Dec;86-A(12):2600-6 Endoscopy & Arthroscopy 8. The Worldwide Orthopaedic Market. Prepared by Knowledge Enterprises. October 2005, p. 11 Integrated Communications 9. Orthopaedic Industry Annual Report: 2008-2009. Orthoworld, Inc. 2009, p. 22 10. Kochan, J. Vertebroplasty and Kyphoplasty, Percutaneous. http://emedicine.medscape.com/article/423209- Beds, Stretchers & EMS overview Accessed September 1, 2009. 11. Wardlaw, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P,Talmadge Sustainability Solutions 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: Neurotechnology & Spine 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 Craniomaxillofacial Surgeons, and American Society of Spine Radiology. J Vasc Interv Radiol 2009; 20:S326–S331 Interventional Spine 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 Neurosurgical, Spine & ENT 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 Neurovascular 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 Spinal Implants 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)) Stryker SA Cité Centre * Information current as of June 2012 Grand-Rue 90 1820 Montreux This document is intended solely for the use of healthcare professionals. Switzerland
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