VertoCure. Reference Guide. VCF Treatment System. zimmer.com

Transcription

1 VertoCure VCF Treatment System Reference Guide zimmer.com

2 VertoCure VCF Treatment System The system VertoCure is indicated in the treatment of Vertebral Compression Fractures (VCF) by vertebroplasty. With the VertoCure Cement Delivery System and VertoCure Spinal Bone Cement, the vertebroplasty procedure is safe, simple and reliable. VertoCure Cement Delivery System Anti-Pressure-Overloading System (APO) The VertoCure Cement Delivery Gun is equipped with APO clutch mechanism. When the pressure of the cement in the syringe is too high due to cement viscosity increase, the APO mechanism is activated to avoid cement pressure overloading. To continue the cement injection procedure, the sensitivity of the APO can be increased manually by turning the crank. This active safety system permits a controlled, progressive and reliable cement injection adapting the delivery system to the bone cement viscosity and preventing rapid and massive injection of cement into the vertebral body. Robust and Ergonomic The VertoCure Cement Delivery Gun is equipped with metallic tightening nut providing a strong and reliable connection between the extension tube and the Cement Delivery Gun. In addition, the ergonomic design ensures a good handling and feel for the cement application Easy and Simple Mixing System The powder and the liquid are mixed with a metallic ball into a plastic vial making the cement preparation simple and reliable. 2

3 VertoCure Spinal Bone Cement The VertoCure Spinal Bone Cement is radiopaque, injectable PMMA bone cement for use in spine surgery, VertoCure Spinal Bone Cement has been specifically designed to meet the vertebroplasty requirements: Comfortable handling time Good viscosity High radiopacity Low hardening temperature Good mechanical properties Comfortable Handling Time At 20 C, 5 minutes after the mixing time, the cement is ready to be injected into the vertebra with an adequate viscosity which persists for 20 minutes. This long working time allows to comfortably perform simple to complex vertebroplasty procedures single to multi-level. Once the VertoCure Spinal Bone Cement is inside the vertebral body at 37 C, the hardening time takes only 10min reducing the risk of cement leakage through the pedicles. Influence of temperature on handling times: (+/- 1 min) Temperature ( C) 25 C 23 C 20 C Time (min) Mixing Injector filing and waiting time Injection time/working time (times obtained with the ZIMMER VertoCure Delivery System) In situ hardening time (test based on the ISO5833 standard) 3

4 Good Viscosity The VertoCure Spinal Bone cement viscosity provides adequate balance between a good cement delivery flow and a reduced risk of cement leakage. Thanks to its adequate viscosity pattern stable over 20min, the VertoCure Spinal Bone Cement permits to achieve an excellent filling of the vertebra with bone /cement interdigitations. Viscosity (Pa.s) , Time (min) VertoCure Spinal Bone Cement (medium viscosity) Low viscosity cement High viscosity cement High Radiopacity The VertoCure Spinal Bone Cement contains 45% Zirconium dioxide (ZrO2) that increases the visibility of the cement flow inside the vertebra on fluoroscopy reducing potential cement leakage. 4

5 Low Hardening Temperature The maximum temperature during the setting is about 45 C (according to ISO5833 standard). This very low exothermic reaction of VertoCure Spinal Bone Cement should prevent the risk of thermic necrosis of bone tissue. Temperature ( C) C C VertoCure Spinal Bone Cement last generation Competitive spinal bone cement Time (min) Good Mechanical Properties The Compressive strength, flexural strength and modulus of VertoCure Spinal Bone Cement meet ISO5833 standard specifications, then the VertoCure Spinal Bone Cement helps guarantee a long term stabilization of the vertebra. Mechanical Data: ISO 5833 VertoCure Compression strength [MPa] E-modulus [MPa] Bending strength [MPa]

6 Technical 1. VertoCure Cement Delivery Gun Description The VertoCure Cement Delivery Gun is equipped with an automatic pressure-overload safety feature (APO). This safety device trips as soon as the pressure inside the bone or the cement viscosity becomes higher than the VertoCure Cement Delivery Gun injection pressure. There are two different operating controls on the injection VertoCure Cement Delivery Gun - A large HANDLE (H) to inject the cement. - A small CRANK (C) to increase the injection pressure. CAUTION: Do not use the CRANK (C) to inject the cement. CRANK (C) Handle (H) DIAL (D) CRANK (C) to adjust the injection force Handle (H) to inject the cement 6

7 2. Cement Preparation and VertoCure Cement Delivery Gun Filling Place the mixing vial into the indicated location within the tray. Place funnel and then the ball into the mixing vial. Cut the corner 15mm from the pouch side. Pour bone cement powder first. 7

8 Then pour liquid monomer. The chronometer starts when the liquid comes in contact with the powder. Screw the lid. Shake up and down with 3 fingers until the required time (see IFU of bone cement). 8

9 Hold the mixing vial upright and remove the blue cap. Luer-lock the Cement Delivery Gun onto the mixing vial. H Hold the Cement Delivery Gun upright with the handle at the bottom and pull out the HANDLE (H) to fill in the required amount of bone cement into the Cement Delivery Gun. 9

10 Turn the DIAL (D) to the Locked position. D 2 Unlock the Cement Delivery Gun from the mixing system. 1 Luer-lock the extension tube onto the Cement Delivery Gun. 10

11 Before injecting the bone cement mixture into the patient, prime the extension tube by turning the Handle (H). H 11

12 3. Cement Delivery Procedure Connect the extension tube to the vertebroplasty cement needle which has already been introduced into the vertebra. H Inject VertoCure Spinal Bone Cement by slowly turning the HANDLE (H) clockwise and monitoring via fluoroscopy. Warning: Never start turning CRANK (C) at this stage. Click C The pressure generated by the VertoCure Cement Delivery Gun can be increased. Rapid injection, high viscosity or elevated bone pressure may increase the pressure and trip the APO system (indicated by an audible click ). To continue bone cement injection after APO system tripped, turn the CRANK (C) by 1/2 turn clockwise to increase the pressure within the Cement Delivery Gun, and then turn the HANDLE (H) to inject cement Repeat this operation as required until the small CRANK (C) is screwed fully home. At this point, the injection pressure is at its maximum. If the safety device trips again, this indicates the end of the injection process. Warning: Do not try to screw the CRANK (C). Any further as this may cause a system failure. 12

13 H Once the required amount of bone cement has been delivered, turn the HANDLE (H) by 1 turn counterclockwise to release the bone cement pressure inside the vertebroplasty needle. Disconnect the extension tube. Use the pusher to clear the vertebroplasty needle and prevent bone cement leakage through the pedicle. 13

14 14 Remove the cement needle.

15 Ordering Information Description VertoCure Cement Delivery System VertoCure Spinal Bone Cement (20g) Part numbers 80E1AS0005M 80E0AS

16 Disclaimer This document is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, contraindications, warnings, precautions, and adverse effects. Manufactured by: Teknimed S.A.S. 8, rue du Franc Pommies Vic en Bigorre - France Distributed by: Zimmer Spine S.A.S. Cité Mondiale 23, parvis des Chartrons Bordeaux - France Tel. +33 (0) Contact: Zimmer Spine S.A.S. Cité Mondiale 23, parvis des Chartrons Bordeaux - France Tel. +33 (0) Zimmer Spine, Inc. Lit. N Ed. 03/