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body The balloon is inflated, compacting the trabeculae and creating a cavity Once the balloon is deflated and withdrawn, the cavity is filled with bone cement Stabilized vertebral body Stryker Bioactive Composite Cortoss Bone Augmentation Material Cortoss is an injectable,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 $ERIVATIVEOF3IMPLEX0"ONE#EMENT s Low creep rate s 7ORKINGTIMEOF