Hemostasis Solutions

Hemostasis Solutions Through innovation and expansion of our therapeutic portfolio, we are proud to offer endoscopy devices to address a variety of hemostasis situations and improve patient care. TABLE OF CONTENTS: Product Name Page Number ASSURANCE® Clip portfolio SmartBand® Multi-Band Ligation System PADLOCK CLIP® Defect Closure System BIOVAC® Direct Suction Device Injection Therapy Solutions GI4000 Electrosurgery Unit & Accessories www.steris.com/endoscopy

ASSURANCE® Clip portfolio overview STERIS Endoscopy offers a complete portfolio of hemostasis clips designed for endoscopic clip placement within the gastrointestinal tract for the purpose of hemostasis, defect closure, endoscopic marking and anchoring. ASSURANCE Clip: Available in 5 sizes, now including 18mm – all offering a minimal tail length allowing for visualization and maneuverability when deploying multiple clips. Six ASSURANCE® Clips closing an esophageal POEM mucosal incision* 63 day follow up found majority of ASSURANCE® Clips in place ASSURANCE Control Clip: Available in 11mm and...

Features & Benefits Feature ASSURANCE® Clip ASSURANCE® Control clip Physician-controlled adjustment Adjust clip arms by rolling the catheter of the device Assistant-controlled adjustment by rotating the handle Enables accurate clip placement Minimal tail length Maneuverability when deploying additional clips Can be opened/closed multiple times Facilitates positioning prior to deployment Design allows for smooth passage through the working channel Aids in tortuous endoscope positions Provides audible and tactile feedback on handle Confirms deployment Catheter Length Released Length Opening Width...

The ASSURANCE Clip has a 7.0mm tail length for visibility and maneuverability Comparison of 16 and 17mm clips* STERIS ENDOSCOPY Tail Length: 7.1mm ASSURANCE® Clip: Opening Width: 16mm Deployed Length: 12.7mm BOSTON SCIENTIFIC Tail Length: 10.6mm Boston Scientific Resolution 360™ ULTRA Clip: Opening Width: 17mm Deployed Length: 17.9mm COOK MEDICAL Cook Instinct® Endoscopic Clip: Opening Width: 16mm Deployed Length: 14.2mm CONMED Tail Length: 7.4mm Conmed DuraClip® Repositionable Hemostasis Clip: Opening Width: 16mm Deployed Length: 13.4mm MICRO-TECH Tail Length: 7.3mm Micro-Tech SureClip™ Hemostasis...

SmartBand® Multi-Band Ligation System features & benefits The SmartBand Multi-Band Ligation System is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction and to ligate internal hemorrhoids. The ligation bands are... • Designed to deliver maximum tissue compression and gripping force Multi-Band Ligation System • Manufactured and packaged to enable a 24-month shelf life SmartBand® SafeGrip Multi-Band Ligation Kit SmartBand® Multi-Band Ligation Kit SmartBand SafeGrip Bands Average Maximum Grip Force (Newtons) Average Compression Force (Newtons) Competitor A...

SmartBand® Multi-Band Ligation System features & benefits Features a universal connector that attaches the handle to the endoscope and is compatible with multiple endoscope styles Provides a dedicated flush port for clearing the working channel during the procedure Offers a 10FR inner diameter handle stem that enables suction capabilities Includes 6 backloaded bands on a clear, smooth barrel for visualization The SmartBand® Packs offer a reloadable barrel of bands for procedures that require more than 6 bands – helping to reduce costs SmartBand® Multi-Band Ligation System Endoscope Diameter Compatibility...

PADLOCK CLIP® Defect Closure System features & benefits The PADLOCK CLIP Defect Closure System facilitates effective full circumferential tissue closure. • A pre-loaded, self-grasping clip designed to encircle, lift, close, and potentiate the healing of tissue defects • Attachment to the outside of the endoscope • Open and free instrument channel for endoscope suction • “Push of the thumb” deployment • May be used with the RAPTOR® Grasping Device to aid tissue recruitment. Prongs gather, lift, and approximate tissue Tissue controllers limit depth of penetration and moderate tissue-on-tissue pressure...

PADLOCK CLIP Defect Closure System indications & case examples The PADLOCK CLIP Defect Closure System is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: Endoscopic marking of lesions, Closure of GI tract luminal perforations <20mm that can be treated conservatively, and Hemostasis for: Mucosal/ Submucosal defects, Bleeding Ulcers, Arteries <2mm, Polyps <1.5cm in diameter, or Diverticula in the Colon. The over-the-scope-clip has successfully been used in the following clinical situations. Hemostasis: Hemostasis Cases: Rebleeding gastric ulcer • Rebleeding...

PADLOCK CLIP Defect Closure System clinical data Study 1: “Novel endoscopic over-the-scope clip system”1 No. Clinical Condition Previous Treatment Treatment Outcome Endoscopic mucosal resection Delayed rectlal bleeding Endoclip, injective therapy Persistent control of the bleeding Solitary rectal ulcer Rectal bleeding Endoclip, injective therapy Persistent control of the bleeding Duodenal Dieulafoy lesion Duodenal bleeding Injective and thermal therapy Persistent control of the bleeding Mediastinal lymphoma Broncho-esophageal fistula Post-laringectomy radiochemoteraphy Tracheo-esophageal fistula...

PADLOCK CLIP Defect Closure System GI Association guidance on the use of over-the-scope clips BLEEDS: AGA • AGA Clinical Practice Update on Endoscopic Therapies for Non-Variceal Upper Gastrointestinal Bleeding: Expert Review Hemostasis using an over-the-scope clip should be considered in select patients with NVUGIB, in whom conventional electrosurgical coagulation and hemostatic clips are unsuccessful or predicted to be ineffective. • Endoscopic Diagnosis and Management of Nonvariceal Upper Gastrointestinal Hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline –...