Biliary Metal Stents MAKING A DIFFERENCE TO HEALTH

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1 Biliary 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 (7fr-0.2r), depending on indication. Silicone Covering: Hanarostent is available fully covered or uncovered depending on the indication. Typically fully covered is more suitable for benign for ease of removal and these stents are CE marked for this indication. Lassos: Nylon lassos are attached to at least one end of most covered stents enabling 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 and fluoroscopy. NYLON LASSOS Allows user to accurately reposition or remove GOLD MARKINGS Ensures excellent visualisation and precise positioning NITINOL WIRE Provides flexibility and excellent radial force 2 Biliary Metal Stents

3 The... 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... 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. 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. Biliary Metal Stents 3

4 SHS Stent FLARED ENDS SHS Non-Covered Biliary Indication: For application in palliative treatment of biliary strictures typically caused by malignant tumours. Uncovered small cell mesh structure limits tissue ingrowth and reduces stent migration 2 GOLD RADIO-OPAQUE MARKERS Crossed mesh design structure increases radial force to provide maximum stent patency Flexible nitinol mesh design enables stent to adapt to anatomy of patient whilst maintaining luminal integrity Less invasive round ends to reduce perforation risk/irritation Flared ends to reduce migration 2 gold radio-opaque markers provide high visibility under fluoroscopic visualisation proximal / central / distal Uncovered SEMS are effective with long patency, low complication rate and easy to place 8mm s SHS SHS SHS SHS SHS mm Percutaneous 0mm SHS SHS SHS SHS SHS SHS SHS SHS SHS SHS Biliary Metal Stents

5 FAST Short Wire Delivery System UNIQUE NITINOL WIRE STRUCTURE Provides optimal radial and axial force OLIVE TIP Flexible and easy access to tight strictures FAST TM Short Wire Delivery System Diagmed Healthcare is pleased to announce the continued expansion of our wide range of Biliary Metal Stents to include the FAST Short Wire Delivery System. The new Hanarostent FAST Range is now available with unique uncovered and fully covered options - the range just got better! The FAST has full compatibility with any long or short-wire ERCP System FAST s design allows the physician better control of the guidewire during the stent placement Unique design allows Short Wire users a wider choice of stent Multiple and clear endoscopic and radiological markers provide better visualisation for a more accurate stent placement The BCG Fully Covered stent has 2 integral flaps at each end which significantly reduce the risk of proximal and/or distal stent migration. **Long Wire version has 4 flaps at each end** SHS SHS BCG s SHS S / 8.5 SHS-08-0-S / 8.5 SHS S / 8.5 SHS S / 8.5 SHS S / 8.5 SHS-0-0-S / 8.5 SHS S / 8.5 SHS-0-00-S / 8.5 BCG S / 8.5 BCG-08-0-S / 8.5 BCG S / 8.5 BCG S / 8.5 BCG-0-0-S / 8.5 BCG S / 8.5 Biliary Metal Stents 5

6 BCG Stent PROXIMAL AND DISTAL FLAPS To reduce migration FULLY COVERED SILICONE LAYER To resist tumour ingrowth BCG Covered Biliary Stent The Hanarostent range of self-expanding biliary stents provide a first-class choice for stricture management in long-wire ERCP procedures. This removable stent is indicated for application in malignant or benign biliary strictures. Fully covered and removable (up to 4 months after placement) 4 integral flaps at each end which significantly reduces the risk of proximal and / or distal migration Fully covered silicone layer to resist tumour ingrowth 6 gold radio-opaque markers on the stent for fluoroscopic visibility High quality nitinol closed cell metal mesh to enhance stent patency 0mm diameter and available in 4 lengths 8.5fr delivery system with Point-Of-No-Return markers for accurate stent placement Radio-opaque and markers on the delivery system for accurate stent placement MRI conditional (up to 3 TESLA) - D.H. Park, 20, GIE Journal, Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures 0mm Percutaneous 0mm s BCG / 8.5 BCG / 8.5 BCG / 8.5 BCG / 8.5 BCG / 8.5 BCG / 8.5 BCG / 8.5 BCG / Biliary Metal Stents

7 BCT Stent BCT Covered Biliary Stent Indication: This removable stent is indicated for application in malignant or benign biliary strictures. Covered with layer of silicone to resist tumour ingrowth allowing optimal flow of bile fluids increasing stent patency Fully covered and removable (up to 4 months after placement) Upper end is fitted with 4 unique flaps to reduce downward migration Lower end flares to 3.5mm to reduce stent upward migration Flexible nitinol mesh design enables stent to adapt to anatomy of patient whilst maintaining luminal integrity Long lasso with radio-opaque marker facilitates inverted stent removal technique Shorter nylon lasso for standard removal / repositioning 5 gold radio-opaque markers provide high visibility under fluoroscopic visualisation - proximal/central/distal/ flaps 0.2Fr TTS delivery device PROXIMAL END Fitted with 4 unique flaps - D.H. Park, 20, GIE Journal, Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures 0mm s BCT / 0.2 BCT / 0.2 BCT / 0.2 BCT / 0.2 BCT / 0.2 Biliary Metal Stents 7

8 SHCL Stent 2 GOLD R ADI OOPAQUE M AR KER S To allow side-by-side placement in hilar ducts NITINOL METAL MESH To enhance stent patency SHCL Covered Biliary Stent Indication: This stent is indicated for application in the treatment of malignant or benign biliary strictures, side-by-side placement in the Fully covered and removable (up to 4 months after placement) Proximal and distal flared ends to reduce migration risk 2 gold radio-opaque markers on the stent for fluoroscopic visibility High quality nitinol closed cell metal mesh to enhance stent patency Narrow 6mm diameter to allow side-by-side placement in hilar ducts Available in 5 lengths 8.5fr delivery system with Point-Of-No-Return markers for accurate stent placement treatment of Klatskin-type tumours, pre-surgical biliary drainage, or Radio-opaque and markers on the delivery system for accurate stent placement post-surgical leaks. MRI conditional (up to 3 TESLA) 8 Biliary Metal Stents SHCL SHCL s / / 8.5 SHCL / 8.5 SHCL / 8.5 SHCL / 8.5

9 BCS Stent BCS Covered Biliary Stent Indication: This removable stent is indicated for application in malignant or benign biliary strictures. Fully covered and removable (up to 4 months after placement) Fully covered layer of silicone to resist tumour ingrowth allowing optimal flow of bile fluids increasing stent patency reducing need to repeat stenting Upper end is fitted with 4 flaps to reduce downward migration Lower end flares to 3.5mm to reduce upward migration Flexible nitinol mesh design enables stent to adapt to anatomy of patient whilst maintaining lumen integrity 4 gold radiopaque markers provide high visibility under fluoroscopic visualisation - proximal/central/distal/ flaps and percutaneous delivery device available 8mm or 0mm diameter available LOWER END FLARES TO 3.5MM - D.H. Park, 20, GIE Journal, Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures 0mm Percutaneous 0mm s BCS0040-D / 8.5 BCS00-D / 8.5 BCS0080-D / 8.5 BCS000-D / 8.5 BCS020-D / 8.5 BCS0040-R / 8.5 BCS00-R / 8.5 BCS0080-R / 8.5 BCS000-R / 8.5 BCS020-R / 8.5 Biliary Metal Stents 9

10 BNY Stent BNY Uncovered Biliary Stent Indication: For application in palliative treatment of biliary strictures and / or Klatskin-type malignant tumours. Larger mesh knitting of stent centre is designed to allow passage of additional SHS biliary Stent for a Y shape implantation in the hilar duct. The larger mesh area is identified with clear fluoroscopic markings Nitinol mesh design enables the stent to adapt to anatomy of patient whilst maintaining lumen integrity ATRAU MATIC END S Atraumatic ends which help conform to the lumen and minimise any Which help conform to the lumen perforation risk 6 gold radio-opaque markers provide high visibility under fluoroscopic visualisation - proximal / distal and to highlight central section for a second stent to pass through This unique stent allows placement of SEMS in both right and left hilar ducts R AD I O - O PAQ U E GOLD M AR KER S Which identify the margins on the wider mesh through which a second stent can be placed Y SHAPE STENT To allow additional passage 0 Biliary Metal Stents

11 BNY Stent WIDER MESH AREA Enables a second metal stent to be positioned in the hilum Effective drainage of the hilar ducts without the high migration risk of traditional stenting methods BNY BNY BNY BNY BNY BNY BNY BNY BNY BNY BNY BNY BNY BNY mm s Percutaneous 8mm BNY BNY mm Percutaneous 0mm Biliary Metal Stents

12 Lumley Close, Thirsk Industrial Park, Thirsk, North Yorkshire, England, YO7 3TD diagmed.healthcare