Colonic Metal Stents MAKING A DIFFERENCE TO HEALTH

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1 Colonic Metal Stents In a fast paced and maturing market, Diagmed Healthcare s Hanarostent has managed to continue to innovate and add unique and clinically superior features to its already premium range. These features add real value to clinical outcome and patient management requirements giving the Hanarostent range a place in every GI and Radiology department. MAKING A DIFFERENCE TO HEALTH

2 The Stent... The Stent... Features and Benefits: Nitinol Wire: Hanarostent is hand weaved using nitinol (nickel titanium alloy). The nitinol mesh provides flexibility and excellent radial force. The thermal shape memory characteristics of nitinol cause the released stent to expand into its predetermined dimensions at body temperature. The stent is compressed into a small calibre introducer (10.2Fr-24Fr), depending on the indication for use. Silicone Covering: Hanarostent is available fully covered, partially covered or uncovered depending on the indication. Typically, fully covered is more suitable for benign diseases for ease of removal and these stents are CE marked for this indication. Lassos: Nylon or string lassos are attached to at least one end, usually distal but in some cases, both ends of the covered stents, enabling the user to accurately reposition or remove with ease. Gold Markings: A minimum of twelve gold radio-opaque markers are located at distal, proximal and central points of the stent to ensure excellent visualisation and precise positioning when using X-ray. GOLD MARKINGS Ensures excellent visualisation and precise positioning LASSOS Allows user to accurately reposition or remove NITINOL WIRE Provides flexibility and excellent radial force 2 Colonic Metal Stents

3 The Delivery Device... Inner lumen for guide wire Olive Tip Radio-opaque ring Inner Sheath Safety Lock Handle Outer Sheath Recapturing radio-opaque marker and repositioning block Visual Marker Black Marker Red Marker Metallic sheath of the inner shaft The outer sheath has to be pulled back toward the handle to allow deployment of the stent Fixed point The Delivery Device... Features and Benefits: Stent Placement Accuracy: The Hanaro Delivery System enables efficient, accurate and easy stenting. Soft and atraumatic radiopaque olive tips can easily pass through the stenosis. The flexibility of the delivery catheter can travel through tortuous anatomy. Endoscopic Placement: The ergonomic handle and TTS delivery system is designed to assist controlled and accurate stent deployment and positioning under direct vision, using a visible yellow endoscopic marker. Fluoroscopic Visualisation: Clear radio-opaque markers on both stent and delivery system ensures accurate placement under X-Ray conditions. Stents deployed through the scope (TTS) can be fully re-sheathed if required with clearly visible point-of-no-return red markers. Colonic Metal Stents 3

4 NCSL Stent TIGHT NITINOL MESH STRUCTURE 12 GOLD RADIO-OPAQUE MARKERS NCSL Uncovered Colonic Stent Indication - For application in palliative treatment of colorectal strictures caused by malignant tumours. Uncovered stent to allow tissue ingrowth reducing the risk of migration of the stent Tight nitinol mesh structure reduces complete tissue ingrowth which can cause blockages or occlusion Nitinol mesh design enables stent to conform to the anatomy of patient whilst maintaining lumen integrity Proximal and distal flared ends of 30mm to minimise migration risk Larger 24mm stent lumen improves obstruction relief and reduces risk of migration Distal lasso to aid repositioning Effective management of colorectal strictures 12 gold radio-opaque markers provide high visibility under fluoroscopic visualisation - proximal/central/distal Reloadable delivery device; up to 70% of the stent can be deployed before re-sheathing Available in Endoscopic (230cm) or Radiological (140cm) delivery systems Ordering Information Product Code Usable Stent (mm) Total Diameters Delivery Device (cm) Diameter (mm/fr) Box Size NCSL / NCSL / NCSL / NCSL / NCSL / 12 1 NCSL / 12 1 NCSL / 12 1 NCSL / Colonic Metal Stents

5 TLC & HRC Stent TLC Partially Covered Colonic Stent Indication: This dual-layered, partially covered stent with very low returning force is indicated for application in palliative treatment of colorectal strictures. HRC Partially Covered Intestinal Stent Indication - For application in palliative treatment of small bowel stricture caused by malignant tumours and the temporary, post-surgical management of Crohn s disease. CE marked for benign strictures - removal within 7 days of placement recommended 1 12 GOLD RADIO- OPAQUE MARKERS On the stent for fluoroscopic visibility Partial silicone covering and closed cell mesh to reduce tumour ingrowth Designed to conform to the lumen to reduce the risk of migration and micro-perforation particularly useful when placing stent across flexures or folds High quality nitinol closed cell metal mesh to enhance stent patency 10.2fr through the scope (TTS) delivery system with clear Point-Of-No-Return markers for accurate stent placement Radio-opaque and Endoscopic markers on the delivery system for accurate stent placement MRI conditional (up to 3 TESLA) Extra wide 40mm flared proximal end to resist migration into ascending colon 20mm stent diameter allows a progressive dilation as an alternative to short term dilatation of a Crohn s stricture Partially covered inside to limit migration and aid throughput Two proximal lassos to aid accurate repositioning and retrieval Stent removal using long lasso to pull the stent inside out Atraumatic ends 10.2fr through the scope (TTS) delivery system with clear Point-Of-No-Return markers for accurate stent placement Ordering Information Product Code Usable Stent (mm) Total Diameters Delivery Device (cm) Diameter (mm/fr) TLC / TLC / TLC / HRC / HRC / Box Size DUAL LAYERED NITINOL MESH With low returning force HRC STENT - PARTIALLY COVERED INSIDE To limit migration 1 - A.Attar, 2017, New antimigration extractible metal stents for Crohn sdisease strictures: A nationwide GETAID-SFED* cohort study Colonic Metal Stents 5

6 CNZ Stent CNZ Uncovered Colonic Stent Indication: Application in palliative treatment of colorectal strictures caused by malignant tumours. Dual layered mesh design with very small cavities to prevent tissue ingrowth Very low returning force provides excellent conformity to patient anatomy whilst significantly reducing stent migration and risk of micro perforation - particularly useful when placing stent across flexures or folds Atraumatic ends reduce ulcerations and discomfort Distal lasso to aid accurate repositioning and retrieval DISTAL LASSO Reloadable delivery device; up to 70% of the stent can be deployed before re-sheathing Available in Endoscopic (230cm) and Radiological (140cm) delivery system Ordering Information DUAL LAYER OF HIGH GRADE NITINOL Product Code Usable Stent (mm) Total Diameters Delivery Device (cm) Diameter (mm/fr) Box Size CNZ / CNZ / CNZ / CNZ / CNZ / 12 1 CNZ / 12 1 CNZ / 12 1 CNZ / Colonic Metal Stents

7 CCBA & CCN Stent CCBA Covered Colorectal Stent Indication - For application in palliative treatment of colorectal strictures caused by malignant tumours and temporary stricture management. Fully covered to prevent tissue ingrowth 26mm flared ends reduce migration 12 gold radio-opaque markers provide high visibility under fluoroscopic visualisation - proximal/central/distal Proximal lasso to aid accurate repositioning and retrieval Reloadable delivery device; up to 70% of the stent can be deployed before re-sheathing CCN Covered Colorectal Stent Indication: For application in palliative treatment of large intestinal strictures caused by malignant tumours - CE marked for benign indications - removal within 4 weeks of stent placement. LARGER 24MM DIAMETER BODY AND 32MM SHOULDERS To reduce migration Distal short shoulder improves patient comfort when stent is positioned close to anal margin Available with usable length of 20mm for short anastomotic stenosis 12 gold radio-opaque markers provide high visibility under fluoroscopic visualisation - proximal/central/distal Proximal and distal lasso to aid accurate repositioning and retrieval - removal within 4 weeks of placement Reloadable delivery device; up to 70% of the stent can be deployed before re-sheathing - OTW delivery device only Ordering Information Product Code Usable Stent (mm) Total Diameters Delivery Device (cm) Diameter (mm/fr) CCBA / CCBA / CCBA / CCN24050-Z / 24 1 CCN24080-Z / 24 1 CCN24150-Z / 24 1 Box Size 26MM FLARED ENDS To reduce migration CCBA STENT CCN STENT FULLY COVERED - To prevent tissue ingrowth Colonic Metal Stents 7

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