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Falena_MIKAI_ultimo_INGL-3

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Roberto Gavuglio

This document provides information about Mikai S.p.a., an Italian company that manufactures the Falena interspinous implant. It lists the company's headquarters and manufacturing facility locations and contact information. It also provides a list of Falena implant sizes and the corresponding instrumentation. The document goes on to describe the surgical technique for implanting the Falena device and details its components, indications for use, benefits, and reversibility.

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CONTACTS HEADQUARTERS: Mikai S.p.a. Via P. Gobetti 56r - 16145 Genova - Italy Tel. +39 010 30801 - Fax +39 010 3080211 www.mikai.it - mikai@mikai.it MANUFACTURING FACILITY: Via Canestrello 2 - 36050 Monteviale (VI) - Italy Tel. +39 0444 950100 - Fax +39 0444 950133 www.mikai.it - mikai@mikai.it Patent Pending. Falena is a registered trademark of Mikai. All rights reserved. IMPLANT ITEM NUMBER DESCRIPTION MMC-5000840 Falena Size 10 (Fuchsia) MMC-5000842 Falena Size 12 (Green) MMC-5000845 Falena Size 15 (Blue) MMC-5000848 Falena Size 18 (Yellow) INSTRUMENTS ITEM NUMBER DESCRIPTION MMC-5000852 Sharp Dilator MMC-5000872 Sizer Handle MMC-5000860 Sizer for Size 10 MMC-5000862 Sizer for Size 12 MMC-5000865 Sizer for Size 15 MMC-5000868 Sizer for Size 18 MMC-5000854 Distractor/Measuring Guide MMC-5000874 Spacer Insertion Grasper MMC-5000880 Sterilization Tray Complete Manuale Falena MIKAI INGL:Layout 1 27-10-2008 15:02 Pagina 1
Place the patient in a prone or late- ral decubitus position based on anesthesia and surgeon evaluation. Make an incision of about 3 cm in the cutis exposing the muscular fa- scia on both sides. Open the tissue and open a hole in the interspinous ligament with the sharp dilator. Distract the hole with the distrac- tor and select the implant size with the graduated gauge positio- ned at the top of the handle. The correct implant size selection can be verified with the appro- priate instrument implant sizers. Screw in the section of the device withpre-mountedwingsontothein- sertion grasper and position the de- vice into the prepared surgical site. Proceed to the alignment of the de- vice assembling the insertion lever on the grasper and close the loc- king rod. Through the inferior scre- wing mechanism, the screw and driver are driven; by means of the superior screw the safety screw ro- tates and blocks the 2nd wing. Pull out the insertion rod and the grasper by unscrewing the first fastening lock on the pin. Limits extension of the spine at the symptomatic levels. Preserves flexion, axial rotation, lateral bending and mo- bility of the symptomatic vertebral section. The device is positioned in the interspinous ligament com- pletely preserving the supraspinous ligament which con- tributes to the equilibrium and stabilization of the spine. The winged structure of the device is manufactured in tita- nium while the spring is manufactured in PEEK OPTIMA 速 polymer, a polymer with rigidity similar to bone and high biocompatibility and wear resistance. The falena device is composed of two components: A winged structure, formed by a main pin with two wings at the extremities and a cap to allow for an atraumatic crossing of the interspinous ligament. A C spring available in a range of height sizes: 10-12-15-18 mm. The C spring heights are varied to allow the surgeon to best adapt the spring for the desired distance from the two adjacent spinous processes, based on the patients unique spine anatomy. Indications: The device is indicated for surgical decom- pression in cases with spinal and radicular stenosis performed with a minimally inva- sive approach under local anesthesia. Minimally invasive procedure with few steps using the dedicated in- strument insertion grasper Preservation of the supraspinous ligament and bone tissue Anesthesia based on surgeon eva- luation Almost immediate pain relief Quick functional recovery Future surgical procedures are not compromised; completely reversible SURGICAL TECHNIQUE Manuale Falena MIKAI INGL:Layout 1 27-10-2008 15:02 Pagina 3

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Falena_MIKAI_ultimo_INGL-3

  • 1. CONTACTS HEADQUARTERS: Mikai S.p.a. Via P. Gobetti 56r - 16145 Genova - Italy Tel. +39 010 30801 - Fax +39 010 3080211 www.mikai.it - mikai@mikai.it MANUFACTURING FACILITY: Via Canestrello 2 - 36050 Monteviale (VI) - Italy Tel. +39 0444 950100 - Fax +39 0444 950133 www.mikai.it - mikai@mikai.it Patent Pending. Falena is a registered trademark of Mikai. All rights reserved. IMPLANT ITEM NUMBER DESCRIPTION MMC-5000840 Falena Size 10 (Fuchsia) MMC-5000842 Falena Size 12 (Green) MMC-5000845 Falena Size 15 (Blue) MMC-5000848 Falena Size 18 (Yellow) INSTRUMENTS ITEM NUMBER DESCRIPTION MMC-5000852 Sharp Dilator MMC-5000872 Sizer Handle MMC-5000860 Sizer for Size 10 MMC-5000862 Sizer for Size 12 MMC-5000865 Sizer for Size 15 MMC-5000868 Sizer for Size 18 MMC-5000854 Distractor/Measuring Guide MMC-5000874 Spacer Insertion Grasper MMC-5000880 Sterilization Tray Complete Manuale Falena MIKAI INGL:Layout 1 27-10-2008 15:02 Pagina 1
  • 2. Place the patient in a prone or late- ral decubitus position based on anesthesia and surgeon evaluation. Make an incision of about 3 cm in the cutis exposing the muscular fa- scia on both sides. Open the tissue and open a hole in the interspinous ligament with the sharp dilator. Distract the hole with the distrac- tor and select the implant size with the graduated gauge positio- ned at the top of the handle. The correct implant size selection can be verified with the appro- priate instrument implant sizers. Screw in the section of the device withpre-mountedwingsontothein- sertion grasper and position the de- vice into the prepared surgical site. Proceed to the alignment of the de- vice assembling the insertion lever on the grasper and close the loc- king rod. Through the inferior scre- wing mechanism, the screw and driver are driven; by means of the superior screw the safety screw ro- tates and blocks the 2nd wing. Pull out the insertion rod and the grasper by unscrewing the first fastening lock on the pin. Limits extension of the spine at the symptomatic levels. Preserves flexion, axial rotation, lateral bending and mo- bility of the symptomatic vertebral section. The device is positioned in the interspinous ligament com- pletely preserving the supraspinous ligament which con- tributes to the equilibrium and stabilization of the spine. The winged structure of the device is manufactured in tita- nium while the spring is manufactured in PEEK OPTIMA 速 polymer, a polymer with rigidity similar to bone and high biocompatibility and wear resistance. The falena device is composed of two components: A winged structure, formed by a main pin with two wings at the extremities and a cap to allow for an atraumatic crossing of the interspinous ligament. A C spring available in a range of height sizes: 10-12-15-18 mm. The C spring heights are varied to allow the surgeon to best adapt the spring for the desired distance from the two adjacent spinous processes, based on the patients unique spine anatomy. Indications: The device is indicated for surgical decom- pression in cases with spinal and radicular stenosis performed with a minimally inva- sive approach under local anesthesia. Minimally invasive procedure with few steps using the dedicated in- strument insertion grasper Preservation of the supraspinous ligament and bone tissue Anesthesia based on surgeon eva- luation Almost immediate pain relief Quick functional recovery Future surgical procedures are not compromised; completely reversible SURGICAL TECHNIQUE Manuale Falena MIKAI INGL:Layout 1 27-10-2008 15:02 Pagina 3