Lapro-Clip Absorbable Clips for Urology

Transcription

1 Lapro-Clip Absorbable Clips for Urology All procedures referenced are performed through the abdomen trademarks of Covidien AG. Other brands are trademarks of a Covidien company Covidien M130059

2 Lapro-Clip Absorbable Clips for Urology Contents Product Description Regulatory Clearance Indications for Use Instructions for Use Product Reorder Codes & Cross Reference Relevant Clinical Literature Reimbursement 2

3 Lapro-Clip Clip Applier Product Family Handle-Short (11 cm) and Standard (26.5 cm) with shaft diameter of 10 mm Clip Remover Clip Sizes- 12 mm & 8 mm

4 Lapro-Clip Clip Applier Product Description (1) DESCRIPTION The Lapro-Clip ligating clip is delivered by a single use cartridge and actuated by a reusable applier. ABSORBABLE CLIPS Lapro-Clip ligating clips are molded from two polymers: polyglycolic acid and polyglyconate. The outer body is polyglycolic acid and slides over a polyglyconate inner track. Lapro-Clip ligating clips are supplied sterile and undyed. Lapro-Clip ligating clips are available in two sizes: Medium/Large and Large. Clips are supplied one clip per single use cartridge with either two or six cartridges per sterile package. The absorption characteristics of polyglycolic acid and polyglyconate have been extensively studied and documented. The breakdown of these two polymers in the body occurs by hydrolysis. REUSABLE HANDLE The Lapro-Clip single clip appliers are available in two sizes: The Lapro-Clip single clip applier short is 11 cm in length with a shaft diameter of 10 mm. The Lapro-Clip single clip applier standard is 26.5 cm in length with a shaft diameter of 10 mm. The standard Lapro-Clip applier is designed to be used through a 10 mm trocar cannula or larger with the use of a converter. Source: Lapro-Clip Instructions for Use (IFU) 4

5 Lapro-Clip Clip Applier Product Description (2) A) CARTRIDGE B) INTERLOCK GROOVE C) SINGLE APPLIER LONG D) ROTATING SHAFT E) END CAP F) HANDLE G) SINGLE APPLIER SHORT H) LATCH I) MEDIUM/LARGE (8 MM) Lapro-Clip SINGLE ABSORBABLE LIGATING CLIP J) LARGE (12 MM) Lapro- Clip SINGLE ABSORBABLE LIGATING CLIP Source: Lapro-Clip Instructions for Use (IFU) 5

6 Lapro-Clip Clip Applier Regulatory Clearance (1) 6

7 Lapro-Clip Clip Applier Regulatory Clearance (2) 7

8 Lapro-Clip Absorbable Clips Indications (1) INDICATIONS Lapro-Clip ligating clips are intended for use as absorbable ligatures. The Lapro-Clip ligating clips are radiotransparent and will not interfere with interpretations of post operative X-Ray, CT or MRI scans. The Lapro-Clip ligating clip may be used for ligation of the cystic artery and cystic duct, and other general ligation. CONTRAINDICATIONS 1. Lapro-Clip ligating clips should not be used where prolonged or permanent ligation of tissues or vessels is required. 2. This device is not intended for contraceptive tubal ligation, but may be used to achieve hemostasis following transection of the fallopian tube. Source: Lapro-Clip Instructions for Use (IFU) 8

9 Lapro-Clip Clip Applier IFU (2) WARNINGS AND PRECAUTIONS 1. The Lapro-Clip reusable clip applier is supplied non-sterile and must be cleaned and sterilized prior to use. 2. The Lapro-Clip reusable clip applier instrument(s) must be carefully inspected prior to and after each use, as any damage may affect the safe operation of the device. Failure to lubricate the device prior to sterilization may cause malfunctions such as jamming, difficult operation or unacceptable staple formation (if applicable). Devices with moving parts should be evaluated for proper function prior to application. If damage is suspected, contact your local representative for replacement or repair by the manufacturer. 3. Ensure that the tissue to be ligated is located completely within the closed clip. 4. Lapro-Clip ligating clips are a secure means of ligation. Prior to closure, all tissue within the clip should be inspected to ensure that the correct tissue will be ligated. It may be difficult to remove a fully closed clip. Improperly placed clips may be removed using Lapro-Clip Ligating Remover. (continued on next page) Source: Lapro-Clip Instructions for Use (IFU) 9

10 Lapro-Clip Clip Applier IFU (3) WARNINGS AND PRECAUTIONS (continued from previous page) 5. Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques. A thorough understanding of the operating principles, risks versus benefits, and the hazards involved in utilizing an endoscopic approach is necessary to avoid possible injury to the user and/or patient. 6. Verify mechanical and electrical compatibility of devices from different manufacturers prior to using them together in a procedure. 7. Autosuture reusable devices must be carefully inspected prior to and after each use, as any damage may affect the safe operation of the device. Failure to lubricate the device prior to sterilization may cause malfunctions such as jamming, difficult operation, or unacceptable staple formation. 8. Devices with moving parts should be evaluated for proper function prior to application. If damage is suspected, contact your local representative for replacement or repair by the manufacturer. 9. Detergents and solutions for reusable devices should have a ph between 7.0 and Sterilization temperature should not exceed 275 F (135 C). Source: Lapro-Clip Instructions for Use (IFU) 10

11 Lapro-Clip Clip Applier IFU Sterilization (1) Lubrication: Prior to sterilization, devices with moving parts must be lubricated with a water soluble lubricant such as Tomac solution to help ensure proper operation. Automatic Cleaning: Autosuture reusable devices may be placed in an automatic dishwasher at 194 F (90 C). Disinfection: See above (automatic cleaning). Sterilization: Autosuture reusable devices are provided non-sterile and are designed for reuse. They may be sterilized in accordance with the following process parameters: Prevacuum Steam Cycle Temperature: F ( C) Time: 4 minutes minimum of exposure, wrapped Gravity Cycle Temperature: F ( C) Time: 15 minutes minimum of exposure, wrapped ETO Cycle 130 F (54 C), mg/l, 40-60% RH, 2 hours exposure minimum, wrapped 100 F (38 C), mg/l, 40-60% RH, 6 hours exposure minimum, wrapped Source: Lapro-Clip Instructions for Use (IFU) 11

12 Lapro-Clip Clip Applier IFU Sterilization (2) Maintenance: Visually inspect the instruments for damage or wear and check for proper function prior to each use. Repeated autoclaving may tarnish or discolor instrument surfaces. Packaging: Items may be placed in a Polyethylene/Tyvek pouch or standard hospital wrap. Storage: Store at room temperature. Additional Information: When sterilizing multiple instruments in one autoclave cycle ensure that the sterilizer manufacturer s stated maximum load is not exceeded. Source: Lapro-Clip Instructions for Use (IFU) 12

13 Lapro-Clip Clip Applier Instructions for Use (1) INSTRUCTIONS FOR USE 1. Cartridge can be removed from package using applier or by hand prior to attachment to instrument. 2. Insert the cartridge into the distal end of the instrument until the latch closes and locks in place. 3. Place the jaws of the cartridge around the tissue to be ligated until they can be seen beyond the tissue. Rotation of the instrument shaft will facilitate placement of the clip cartridge. Ensure that the tissue to be ligated is located completely within the confines of the clip prior to closure. 4. The handle should be firmly squeezed until it will not move further without excessive force. CAUTION: Failure to fully squeeze the handle may result in misformed clips which may result in incomplete closure and lack of hemostasis. 5. (Closure sequence of a clip.) 6. Clip will be released when handle is fully compressed. 7. The clip should be inspected to ensure closure and adequate ligation. 8. After firing clip, cartridge is removed by depressing the release button on shaft and pulling the cartridge forward, away from applier. K) RELEASE BUTTON Source: Lapro-Clip Instructions for Use (IFU) 13

14 Lapro-Clip Clip Applier Instructions for Use (2) DISASSEMBLY 1. Unscrew the end cap. 2. Push the handle forward. 3. Remove the inner shaft assembly. ASSEMBLY 1. Push the handle forward. 2. Replace the inner shaft assembly taking care that all grooves are aligned between the handle, inner shaft, and rotating shaft. A) TOP VIEW OF GROOVES 3. Pull the handle back and replace the end cap. Source: Lapro-Clip Instructions for Use (IFU) 14

15 Lapro-Clip Clip Applier Product Order Codes Reorder Code Description Each/Sterile packs per box Clips per sterile pack LAPCLP LIGCLP APPL - Single Clip Applier (METAL INSTR) 1 NA Lapro-Clip Short Single Clip Applier (METAL INSTR) 1 NA Lapro-Clip Remover (METAL INSTR) 1 NA LAPRO-CLIP 8MM LPW -For Use with Single Clip Appliers (Disposable / Consumable) 6 6 LAPR-CLIP 12MM LPW -For Use with Single Clip Appliers (Disposable / Consumable) 6 6 LAPROCLIP 8MM 10X2 -For Use with Single Clip Appliers (Disposable / Consumable) 10 2 SNGL LAPRO-CLIP 12MM -For Use with Single Clip Appliers (Disposable / Consumable)

16 Lapro-Clip Clip Applier Products: Competitive Cross Reference Item Code (SKU #) Item Description Each/sterile packs per box) Clips per sterile pack Hem-o-lok Medium-Large Polymer clips Hem-o-lok Large Polymer clips Endo 10 L, 32cm applier, 10mm cm remover, 10mm

17 Relevant Clinical Literature Article Title Authors Publication Date The use of Absorbable clips in Laparoscopic Cholecystectomy Abdelkader Hawasli 1994 Initial experience with an absorbable laparoscopic ligation clip Bladder Neck Contractures Related to the Use of Hem-O-Lok Clips in Robot-Assisted Laparoscopic Radical Prostatectomy Development of Independent Vessel Security After Ligation With Absorbable Sutures or Clips Comparison of titanium and absorbable polymeric surgical clips for laparoscopic cholecystectomy A. Darzi, B. Soin, J. Coleman*, N. M. Liricit and L. Angelinit 1997 Kevin B. Blumenthal, Douglas E. Sutherland, Kristofer R. Wagner, Harold A. Frazier, and Jason D. Engel 2008 Robert M. Brohim, MD, Pamela A. Foresman, BA, George T. Rodeheaver, PhD, Charlottesville, Virginia 1993 R. D. Klein, 1 G. Jessup, 2 F. Ahari, 2 R. J. Connolly, 1 S. D. Schwaitzberg

18 Reimbursement Information Prostatectomy Laparoscopic Prostatecomy Robotic Assisted Codes ICD - 9 Procedure Code Description ICD - 9 Procedure Code Description 60.5 Radical prostatectomy Laparoscopic robotic assisted procedure Please note the ICD 9 Procedure code for Radical Prostatectomy does not differentiate between an open or laparoscopic approach Percutaneous robotic assisted procedure Endoscopic robotic assisted procedure Other and unspecified robotic assisted procedure CPT Procedure Code Description CPT Procedure Code Description Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed S2900 Surgical techniques requiring use of robotic surgical system (list separately in addition to code for primary procedure) Note, code includes robotic assistance when performed. The S code S2900 is used to provide more specificity by many insurers including BCBS and Medicaid, however it is not payable by Medicare 18

19 Reimbursement Information Nephrectomy Laparoscopic Nephrectomy Robotic Assisted Codes ICD - 9 Procedure Code Description ICD - 9 Procedure Code Description 55.4 Partial nephrectomy Laparoscopic robotic assisted procedure 55.5 Complete nephrectomy Percutaneous robotic assisted procedure Nephroureterectomy Endoscopic robotic assisted procedure Nephrectomy of remaining kidney Other and unspecified robotic assisted procedure Removal of transplanted or rejected kidney Bilateral nephrectomy Please note the ICD 9 Procedure codes for Nephrectomy do not differentiate between an open or laparoscopic approach CPT Procedure Code Description CPT Procedure Code Description Surgical techniques requiring use of robotic surgical system (list separately in addition to Laparoscopy, surgical; partial nephrectomy S2900 code for primary procedure) Laparoscopy, surgical; pyeloplasty Laparoscopy, surgical; radical nephrectomy (includes removal of Gerota's fascia and surrounding fatty tissue, removal of regional lymph nodes, and adrenalectomy) Laparoscopy, surgical; nephrectomy, including partial ureterectomy Laparoscopy, surgical; donor nephrectomy (including cold preservation), from living donor Laparoscopy, surgical; nephrectomy with total ureterectomy Unlisted laparoscopy procedure, renal 19