Enteral Access Devices - Boston Scientific

1 Product and Procedure GuideE n doVi ve Enteral Access DevicesENFit Transition Frequently Asked Questions for Hospitals & HCPsIs the Boston Scientific portfolio ENFit compatible? Yes, our Enteral Feeding portfolio is ENFit hospital has questions about ENFit where can I get more information? You can call, text, or email your Boston Scientific Representative anytime with ENFit questions. ENFit resources on BOX: https:// Boston there any other ENFit resources my hospital can reference? GEDSA: GEDSA YouTube Channel: Ewlol9bOO GEDSA Position Statement on ENFit FDA Letter: FDA Letter Encouraging Hospitals to move to ENFit: CMS Memo on ENFit: of ContentsEndoVive Initial Placements ..2 One-Step Button Gastrostomy Device Safety Percutaneous Endoscopic Gastrostomy (PEG) Kit Standard Percutaneous Endoscopic Gastrostomy (PEG) Kit EndoVive Through-The-PEG (TTP) Jejunal Feeding Tube.

2 6 EndoVive Gastrostomy Tubes ..8 Standard: Straight and Right AngleProcedure Guides ..12 One-Step Button Jejunal Feeding Tube ProcedureEnteral Feeding ..Back Cover Procedural Reimbursement GuideENFit IntroductionNew standards have been implemented to address safety issues related to Enteral feeding, resulting in the design of the ISO Standard 80369-3 Connection system. The ENFit Connector was designed to reduce the risk of a non-feeding tube device being connected to a feeding tube port. All Enteral Access Devices , including feeding tubes, administration sets and Enteral syringes will be impacted by these changes. The New ENFit Connector Provides a way to reduce the risk of Enteral tube feeding misconnections Addresses bedside mis-connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other Enteral devicesInitial PlacementsOne Step ButtonOne-Step Button Gastrostomy Device2 Deployed One-Step ButtonOne-Step Button Delivery SystemEndoVive Enteral Access DevicesProduct FeaturesCost Effective A cost-effective solution to provide low profile Enteral feeding in one initial procedureHigh-Grade Silicone Button-Bolstered Low Profile Initial Placement Designed for performance and consistent flow Radiopaque silicone designed to enhance placement confirmationLow Profile Design Low profile design helps reduce risk of accidental pull-out Product flexibility at skin level designed to enhance patient comfort and cosmetic appealUniversal mm x 240 cm Retrieval Snare Designed to traverse scopes with a mm or larger working channelAnti-Reflux Valve Designed to help reduce gastric backflow Kit includes accessories designed to allow for gastric

3 DecompressionMultiple Sizes and Accessories Color-coded French sizes with corresponding feeding accessories and multiple lengths for broad patient coverage Specially designed round spacers to accommodate in-between sizes and short-term weight gainOne-Step Button Low Profile PEG KitsNon-ENFit CodesENFit CodesDescriptionLength (cm)Color CodeUnitsM00563120M0050969018Fr Low Profile PEG Kit, 1M00563130M0050970018Fr Low Profile PEG Kit, 1M00563140M0050971018Fr Low Profile PEG Kit, 1M00563150M0050972018Fr Low Profile PEG Kit, 1M00563160M0050973018Fr Low Profile PEG Kit, 1M00563180M0050974018Fr Low Profile PEG Kit, Push (Guidewire) 1M00563190M0050975018Fr Low Profile PEG Kit, Push (Guidewire) 1M00563010M0050958024Fr Low Profile PEG Kit, 1M00563020M0050959024Fr Low Profile PEG Kit, 1M00563030M0050960024Fr Low Profile PEG Kit, 1M00563040M0050961024Fr Low Profile PEG Kit, 1M00563080M0050963024Fr Low Profile PEG Kit, Push (Guidewire) 1M00563090M0050962024Fr Low Profile PEG Kit, Push (Guidewire) 1M00563100M0050968024Fr Low Profile PEG Kit, Push (Guidewire)

4 1 * One-Step Button and Low Profile Accessories can be found on Page 8 Low Profile Button Replacement Feeding Tubes3 Product FeaturesHigh-Grade Silicone Button-Bolstered Low Profile Replacement Radiopaque silicone designed to enhance placement confirmation Inserted through an existing stoma tract Low profile design helps reduce risk of accidental pull-out Product flexibility at skin level designed to enhance patient comfort and cosmetic appeal Designed to reduce gastric backflow Kit includes accessories designed to allow for gastric decompression Color-coded French sizes with corresponding feeding accessories and multiple lengths for broad patient coverage Specially designed round spacers to accommodate in-between sizes and short-term weight gain Low Profile Button Replacement(1) Button Kit(2) Percutaneous Stoma Measuring Device (PSMD)(1) Spacer Disk Variety Pack(1) Right Angle Decompression Tube(1) Patient Care Kit 60cc Catheter Tip Syringe Right Angle Feeding Set Bolus Feeding Set EndoVive Patient Care Booklet KIT CONTENTSLow Profile Button ReplacementsNon-ENFit CodesENFit CodesDescriptionLength (cm)UnitsM00562760M0050983018Fr Low Profile Button 1M00562770M0050984018Fr Low Profile Button 1M00562780M0050985018Fr Low Profile Button 1M00562790M0050986018Fr Low Profile Button 1M00562800M0050987018Fr Low Profile Button 1M00562820M0050941024Fr Low Profile Button 1M00562830M0050942024Fr Low Profile Button 1M00562840M0050943024Fr Low Profile Button 1M00562850M0050944024Fr Low Profile Button 1 Low Profile Button AccessoriesNon-ENFit CodesENFit CodesDescriptionLength (cm)

5 UnitsM00580401M0050112118Fr Decompression Tube 10M00580411M0050113118Fr Decompression 10M00580421M0050114118Fr Decompression 10M00580431M0050115118Fr Decompression 10M00580441M0050116118Fr Decompression 10M00580461M0050118124Fr Decompression 10M00580471M0050119124Fr Decompression 10M00580481M0050120124Fr Decompression 10M00580491M0050121124Fr Decompression 10M00580171M0050109118Fr Bolus Straight AdapterBox 10M00580181M0050106118Fr Continuous Right-Angle AdapterBox 10M00580231M0050110124Fr Bolus Straight AdapterBox 10M00580241M0050107124Fr Continuous Right-Angle AdapterBox 104 Standard Percutaneous Endoscopic Gastrostomy (PEG) KitHigh-Grade Silicone Dome-Bolstered PEG TubeHigh-Grade Silicone TubeProduct FeaturesHigh-Grade Silicone Dome-Bolstered PEG Tube Designed for performance and consistent flow Facilitates traction removalUniversal mm x 240 cm Retrieval Snare Traverses scopes with a mm or larger working channel universal -sized snare, intended to eliminate the cost of a specialty snareDouble-Tier Tray Packaging Kit organization promotes procedural efficiency External Bolsters Two external bolster options: accommodates physician and patient needs: Round.

6 T-BarMultiple Sizes and Accessories Multiple French sizes for broad patient coverage Separate feeding ports C-Clamp designed to help reduce risk of tube reflux and leakingStandard PEG KitNon-ENFit CodesENFit CodesDescriptionUnitsM00568201M005090412 0Fr Standard PEG Kit, Pull with Lidocaine AmpuleBox 2M00568211M0050905120Fr Standard PEG Kit, Push with Lidocaine AmpuleBox 2M00568241M0050906124Fr Standard PEG Kit, Pull with Lidocaine AmpuleBox 2M00568251M0050907124Fr Standard PEG Kit, Push with Lidocaine AmpuleBox 2 PEG AccessoriesNon-ENFit CodesENFit CodesDescriptionUnitsM00580641M005012612 0Fr Y-PortsBox 10M00580651M0050127124Fr Y-PortsBox 10M00580731N/A20Fr Round BolstersBox 10M00580781N/AC-Clamps (Fits 20Fr and 24Fr) Box 10 Initial PlacementsSafety Percutaneous Endoscopic Gastrostomy (PEG) Kit5 EndoVive Enteral Access DevicesProduct FeaturesDeluxe Safety PEG Procedure Kit High-grade silicone dome-bolstered PEG tube ChloraPrep Skin Preparation universal mm x 240 cm retrieval snare Double-tier tray packaging Two external bolsters Multiple sizes and accessories Available for push and pull methodsSafety Trocar Catheter Needle tip protector designed to engage when the needle stylet is removed from the needle cannula Designed to allow re-activation by replacing the needle stylet back into the needle cannulaSafety-Shielded Scalpel Thumb-activated safety mechanism retracts spring-loaded No.

7 11 surgical blade into handleSafetyGlide Shielded Injection Needle 22 gauge x " needle designed for injection into abdominal wall Shielding mechanism designed for one-finger activationPEG Accessories Y-Ports Round Bolsters T-Bar Bolster C-ClampsStandard PEG KitNon-ENFit CodesENFit CodesDescriptionUnitsM00568201M005090412 0Fr Standard PEG Kit, Pull with Lidocaine AmpuleBox 2M00568211M0050905120Fr Standard PEG Kit, Push with Lidocaine AmpuleBox 2M00568241M0050906124Fr Standard PEG Kit, Pull with Lidocaine AmpuleBox 2M00568251M0050907124Fr Standard PEG Kit, Push with Lidocaine AmpuleBox 2 PEG AccessoriesNon-ENFit CodesENFit CodesDescriptionUnitsM00580641M005012612 0Fr Y-PortsBox 10M00580651M0050127124Fr Y-PortsBox 10M00580731N/A20Fr Round BolstersBox 10M00580781N/AC-Clamps (Fits 20Fr and 24Fr) Box 10Y-Port with Stepped Design Round Bolster C-ClampThrough-The-PEG6 Through-The-PEG (TTP) Jejunal Feeding TubeResolution 360 Clip grasping suture loopResolution 360 Clip anchoring suture and jejunal tube to jejunal wallEndoVive Enteral Access DevicesResolution 360 ClipProduct FeaturesInnovative Device Design Designed for placement through an existing Standard PEG 68 cm length, TTP J-Tube compatible with 20Fr PEG 68 cm length, 12Fr TTP J-Tube compatible with 24Fr PEG Available in Pigtail Tip and Bent Tip designs, each with a suture loop intended to facilitate distal tip anchoring past the Ligament of Treitz Compatible with both Pull and Push (over-the-wire)

8 Placement TechniquesFlexima Material Radiopaque material facilitates fluoroscopic visualizationTemp Tip Temporary tapered tip designed to provide smooth tracking into the jejunum to help ensure proper placement Temp Tip is designed to dissolve at body temperature permitting utilization of the full distal tip lumen diameter which may help reduce premature tube cloggingHollow Stiffening Stylet Provides added stiffness designed to improve pushability and permit greater physician control during placementRecommended Anchoring Device Resolution Clip or Resolution 360 Clip Physician controlled rotation designed to allow easier grasping of J-Tube suture TTP Jejunal Feeding Tube Order NumberDescriptionTip TTP Jejunal Feeding Tube Bent TipBox TTP Jejunal Feeding TubePigtail TipBox 1M0056634012Fr TTP Jejunal Feeding TubeBent TipBox 1M0056635012Fr TTP Jejunal Feeding TubePigtail TipBox 1 Recommended Anchoring DeviceOrder NumberDescriptionWorking Length (cm)Minimum Working Channel (mm)Clip Opening (mm)UnitsM00521240 Resolution 360 360 10M00521242 Resolution 360 20M00521230 Resolution 360 360 10M00521232 Resolution 360 20M00521233 Resolution 360 40* Distal ENFit adapter can be used in conjunction with the J-tube feeding port to accommodate ENFit syringes.

9 7 Bent TipPigtailFeeding Tube(1) TTP Jejunal Feeding Tube(1) Flexible Stiffening Cannula with Detachable Barbed Connector(1) Guidewire(4) 4 x 4 Gauze Squares(1) Lubricating Jelly(2) Retention Ring KIT CONTENTS8 Right-Angle Gastrostomy TubeStandard Gastrostomy TubeGastrostomy TubesStandard Balloon Replacement KitsEndoVive Enteral Access DevicesProduct FeaturesLow Profile Pancake Shaped Balloon Designed to offer the deflation characteristics of a balloon for insertion and removal that may be more comfortable for the patient Consistent 6 ml balloon inflation across all sizes (12Fr = 4ml)Replacement Gastrostomy Tube with Optional Right-Angled External Bolster Designed to minimize the potential tube kinking when it s taped down Designed to minimize premature pull out due to shape of the tube Separate medication and feeding ports Clear shaft for internal lumen visualizationReplacement G-TubesOrder NumberDescriptionUnitsM0058204012Fr Replacement G-Tube, StraightBox 1M0058205014Fr Replacement G-Tube, StraightBox 1M0058206016Fr Replacement G-Tube, StraightBox 1M0058207018Fr Replacement G-Tube, StraightBox 1M0058208020Fr Replacement G-Tube, StraightBox 1M0058286022Fr Replacement G-Tube, StraightBox 1M0058209024Fr Replacement G-Tube, StraightBox 1M0058210028Fr Replacement G-Tube, StraightBox 1M0058211012Fr Replacement G-Tube, Right-AngleBox 1M0058212014Fr Replacement G-Tube, Right-AngleBox 1M0058213016Fr Replacement G-Tube, Right-AngleBox 1M0058214018Fr Replacement G-Tube.

10 Right-AngleBox 1M0058215020Fr Replacement G-Tube, Right-AngleBox 1M0058287022Fr Replacement G-Tube, Right-AngleBox 1M0058216024Fr Replacement G-Tube, Right-AngleBox 1M0058217028Fr Replacement G-Tube, Right-AngleBox 1(1) Balloon Replacement with Straight or Right-Angle External Bolster (2) 4 x 4 Gauze Pads(1) 6 ml Syringe(1) Lubricating Jelly KIT CONTENTS9 Gastrostomy Tubes10 EndoVive Gastrostomy Tube with ENFit ConnectorEndoVive Enteral Access DevicesReplacement G-Tubes with ENFitNEWO rder NumberDescriptionLength (cm)M00509881 Gastrostomy Tube, Straight, Replacement with ENFit12 FrM00509891 Gastrostomy Tube, Straight, Replacement with ENFit14 FrM00509901 Gastrostomy Tube, Straight, Replacement with ENFit16 FrM00509911 Gastrostomy Tube, Straight, Replacement with ENFit18 FrM00509921 Gastrostomy Tube, Straight, Replacement with ENFit20 FrM00509941 Gastrostomy Tube, Straight, Replacement with ENFit24 FrM00509961 Gastrostomy Tube, right angle, Replacement with ENFit12 FrM00509971 Gastrostomy Tube, right angle, Replacement with ENFit14 FrM00509981 Gastrostomy Tube, right angle, Replacement with ENFit16 FrM00509991 Gastrostomy Tube, right angle, Replacement with ENFit18 FrM00510001 Gastrostomy Tub