COMPREHENSIVE “PRIMARY CARE” VERTEBROPLASTY CLINIC IN A FREE-STANDING, RADIOLOGIST OWNED DIAGNOSTIC IMAGING CENTER-DIAGNOSTIC, TREATMENT, PREVENTION AND FOLLOW-UP OF VCFs BY H. PAUL HATTEN, Jr., M.D. INDIAN RIVER RADIOLOGY VERO BEACH, FLORIDA, USA

DISCLOSURE

INDIAN RIVER COUNTY Full Time Population 141,667 (est. 2009) Seasonal Population 163,531 (est. 2009)

INDIAN RIVER RADIOLOGY Free Standing Diagnostic Imaging Center (DIC) 6,268 square feet 4 Board Certified Radiolgists

EQUIPMENT CT – Marconi MX 8000 Fluoro DEXA – GE Lunar Plain Films Ultrasound – Sequoia Acuson MRI – 1.0 Tesla Philips Open

OFFICE PROCEDURES SI Joint Injections ESI’s - CT Guidance Bone Biopsies Soft Tissue Biopsies - CT - Ultrasound

VERTEBROPLASTIES HPH – CAQ Neuroradiology Started Vertebroplasties Vertebroplasties as of 8/31/2010

AMBULATORY SURGERY CENTER (ASC) Radiolgist helped organize and design Siemens 23” C-Arm

New Technologies: Novel Vertebroplasty Materials

CERAMENT™ Bi-Phasic Ceramic Bone Substitute:- Enhances the bulk of cancellous bone:- - Biologically - Biomechanically

Bio-Material Characteristics 60 wt % α-calcium sulfate hemihydrate (CaS) 40 wt % hydroxyapatite (HA)  High injectability allows for minimal invasive delivery and ensures good intraosseal spread Iohexol-based radio-opacity enhancing component (liquid)  Makes the material visible under fluoroscopy Short term strength Resorbable during months CaS Long term support Highly osteoconductive HA

CERAMENT™ U.S.A. Pilot Results 90% of 20 patients treated have complete pain relief Pain improved from VAS 8.5 av. pre-op to 1.8 av. at one week 17 patients at 6 months with av. VAS of patients at 12 months with av. VAS of 0.6 One adjacent level fractures to date 11 months post-surgery

At 12 weeks, there is extensive new bone formation, cement resorption, and cement incorporation in the bi-phasic ceramic-filled defect CRITICAL DEFECT IN RABBIT Empty Bi-Phasic Ceramic C C nB

Progression of Resorption of Cerament™ and Bone Incorporation beyond 1 year Axial CT Scan, L1: Day 1 Axial CT Scan, L1: 13 Months

Professional Bowler: Levels L3 & L4 Treated Post Operative CT Scan Pre Operative MRI Returns to Professional Bowling in Las Vegas Tournament 14 days Post Cerament™ Vertebroplasty.

“PRIMARY CARE” VERTEBROPLASTY CLINIC Osteoporosis Counseling - Reclast Infusion Center - Calcium & Vitamin D Vertebroplasty Pain Management (no pain meds)

REQUEST Imaging Pain Treatment - Vertebroplasty - ESI’s - SI Joint Injection - Facet Injections

PATIENT FOLLOW-UP RN Nurse Coordinator calls all pain management patients day following procedure. All Verterbroplasty patients called by Dr. Hatten evening of procedure. Any new pain and/or VCF call RN Nurse Coordinator.

OSTEOPOROSIS COUNSELING Vitamin D Calcium Bisphosphonate Treatment (Reduces risk of VCF’s by 50%)

RECLAST INFUSION CENTER Initiated February 2009 Reclast (Zoledronic Acid – Novartis Pharaceutical) Annual Infusion

“PRIMARY CARE” VERTEBROPLASTY CLINIC VCF - Verebroplasty - Prevention - Follow-up - New VCF’s Spine Interventional Procedures - ESI’s - SI Joint Injections General Radiology Procedures