CTO Product Portfolio

Transcription

1 CTO Product Portfolio 1 2 CTO Recanalization Via ATHERECTOMY Occluded anterior tibial artery Tip of Crosser Catheter 3 4 Central lumen vessel recanalization by the Crosser Catheter The Crosser Catheter facilitated full central lumen recanlization of the anterior tibial artery

2 CTO Recanalization Via Atherectomy Atherectomy Reimbursement See procedural codes for appropriate atherectomy CPT codes Frontline Therapy * Enables Central Lumen Crossing * Maximizes Therapeutic Options * Procedural Steps Crosser Catheter advanced over guidewire to CTO Crosser Catheter activation Guidewire advanced into distal lumen Therapeutic devices delivered over existing guidewire Focused Efficiency Efficiency The small Crosser Catheter S6 tip focuses vibrational energy providing greater efficiency Flexibility* Improved flexibility of Crosser Catheter S6 facilitates deliverability to small and tortuous vessels *Data on file at the BPV FlowCardia Technology Center.

3 Support and Steerability Support Stainless Steel, Braided Shaft Construction For greater catheter push, stability and lumen integrity Steer Angled Tip Configuration Provides steerability to the Crosser Catheter tip MicroSheath XLT Tapered Vertebral MicroSheath XL Vertebral MicroSheath XLT Tapered Straight MicroSheath XL Straight Usher Support Catheter Low Profile Efficiency Steerability* Usher Angled Tip Support Catheter provides improved steerability and directability to assist with central lumen crossing Smooth Transition Offers a low profile tip to Crosser S6 Catheter transition to facilitate crossing CTO s *Data on file at the BPV FlowCardia Technology Center.

4 1:1 Torque Control.014" Crosser Catheter Steerability Various tip stiffness levels provide precise steerability with 1:1 torque transmission 12 Gram Force Crosser Catheter Delivery Unique hydrophilic Porter Guidewire coating provides enhanced trackability in tortuous anatomy Measured Performance.014".018".035" Lowest Tip Entry Profile Available Promotes enhanced deliverability and entry in distal lesions and complex vasculature Unmatched Radiopaque Marking System Provides superior lesion length measurement cabability to determine PTA and stent length treatment options

5 Injector Control, Convenience, Integration Control Single foot switch activates FlowMate Injector and Crosser Generator Physician controls procedure and pace Convenience Fixed injector settings Single-operator control Crosser Generator System Integration Single IV pole houses FlowMate Injector and Crosser Generator Precise activation and saline delivery optimizes Crosser Catheter performance Indications For Use The Crosser Recanalization System is indicated to facilitate the intraluminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. Flowmate Injector Settings (pre-set) Flow Rate: Pressure: Volume: Rise/Fall: Delay: Injection: 18 ml/min (0.3ml/sec) 200 PSI (13.8 Bar) 20 ml 0 seconds 0 seconds Multi

6 Crosser CTO Recanalization Catheter ATK POP BTK Crosser Catheter S6 Usher Support Catheters All Regions & Highly Calcified Lesions ATK POP BTK Crosser Catheter 14S (OTW & RX) MicroSheath XL Support Catheters ATK & POP Regions Crosser Catheter 14P (OTW & RX) MicroSheath XL Support Catheters POP & BTK Regions Recommended Accessories Devices MicroSheath Support Catheter: Crosser Catheter 14P & 14S Usher Support Catheter: Crosser Catheter S6 Porter - Guidewire Seeker Crossing Support Catheter - Guidewire Exchange Catheter Flowmate Procedural Kit

7 Ordering Information Peripheral Crosser CTO Recanalization Catheters Product Name Length Platform Item Number Crosser Catheter S6 Crosser Catheter 14P Crosser Catheter 14S Abbreviated Partial Description *Stent and Atherectomy with or without Angioplasty Product Name 154 cm CRUS6A n/a 106 cm CRUS cm 106 cm 146 cm 106 cm Crosser Generator System Electronics FlowMate Injector FlowMate Procedural Kit RX OTW RX OTW RX OTW RX OTW Atherectomy Reimbursement Information * See Bard Reimbursement Guide for full procedural CPT Codes. Femoral/Popliteal Artery Revascularization Tibial/Peroneal Artery Revascularization REPRESENTATIVE NAME CONTACT PHONE NO. CRU14PA CRUO14PA CRUP106 CRUOP106 CRU14SA CRUO14SA CRUS106 CRUOS106 Catalog Number GEN200 INJ100 INJKIT CPT Code Adjunctive Devices MicroSheath Support Catheter For use with Crosser Peripheral CTO Recanalization Catheters 14P and 14S Product Name Length Shape Item Number MicroSheath XL Support Catheter MicroSheath XLT Support Catheter Usher Support Catheter XL/XLT 110 cm Straight Vertebral MSXL17110 MSXL17110V 70 cm Straight MSXL cm 70 cm Vertebral Tapered Straight Tapered Vertebral Tapered Straight Tapered Vertebral For use with Crosser Peripheral CTO Recanalization Catheters S6 Guidewire Support & Exchange Catheters MSXL1770V MSXLT110 MSXLT110V MSXLT70 MSXLT70V Product Name Length Shape Item Number Usher Support Catheter Product Name (5/box) Guidewire Length Item Number Seeker Crossing Support Catheter Scan with a Smart Phone and your local Bard Rep will contact you. 130 cm 83 cm.014".018".035" Straight Angled Straight Angled USH07ST USH07AT USH07ST83 USH07AT cm SK cm SK cm SK cm SK cm SK cm SK6535M 90 cm SK9035M 135 cm SK13535M 150 cm SK15035M PHYSICIAN S SIGNATURE Bard Peripheral Vascular, Inc W. 3rd Street Tempe, AZ USA Tel: / Fax: / Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions and instructions for use. Bard, Crosser, FlowCardia, FlowMate, MicroSheath, Porter, Seeker and Usher are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. Copyright 2012, C. R. Bard, Inc. All Rights Reserved. S Rev 0 Guidewires Product Name (5/box) Wire Size Length Tip Stiffness Item Number 3 g GWP cm 6 g GWP g GWP1403X Porter Guidewire.014" 6 g GWP1406X 300 cm 9 g GWP1409X 12 g GWP1412X

8 The Crosser CTO Recanalization Catheter Indications: The Crosser Recanalization System is indicated to facilitate the intraluminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The Crosser Catheter is only intended for use with the Crosser Generator. Refer to the Crosser Generator Manual of Operations for proper use. Contraindications: The device is contraindicated for use in carotid arteries. Warnings and Precautions: 1) The Crosser Recanalization System should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA). 2)Prior to use, the packaging and product should be inspected for signs of damage. Never use damaged product or product from a damaged package. 3) DO NOT activate the Crosser Recanalization System without proper irrigation. Make sure to establish proper irrigation prior to introduction into guide catheter. Always use REFRIGERATED SALINE. 4) The Crosser Recanalization System should be used in conjunction with proper anticoagulation agents. 5) Never advance or withdraw the Crosser Catheter without proper fluoroscopic guidance. 6) It is not recommended to use the Crosser Catheter over wires which have polymer-jacketed distal ends. 7) Do not exceed 5 minutes of activation time as Crosser Catheter malfunction may occur. If 5 minutes of activation time is achieved exchange for a second Crosser Catheter before resetting the Crosser Generator. 8) When using the Crosser Catheter 14S or 14P with the MicroSheath XL Support Catheter Tapered, the Crosser Catheter can be advanced approximately 15cm from the tip of the support catheter before resistance is encountered due to the taper on the Crosser Catheter aligning with the taper on the support catheter. A taper lock-up marker (single marker on the Crosser Catheter shaft) is located 127cm from the distal tip for the 146cm Crosser Catheter and 87cm from the distal tip for the 106cm Crosser Catheter. The taper lock-up marker can be used as an indicator that the tapers on the catheters are nearing alignment; advance the Crosser Catheter slowly. Do not continue to advance the Crosser Catheter if resistance is encountered. 9) When manipulating the Crosser Catheter, the Catheter shaft may become warm to the touch. A warm feeling is normal, however, if the Catheter shaft becomes hot discontinue use immediately and withdraw from patient. Once removed from the patient confirm that irrigation is flowing. 10) When using the Crosser Catheter in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the Crosser Catheter tip. Kinking or prolapse of the tip could cause catheter breakage and/or malfunction. 11) Position Foot Switch and cable to minimize potential tripping hazard. 12) Ensure Crosser Generator is securely mounted to IV pole to reduce risk of falling. 13) Should high frequency vibration fail to stop when foot switch is released, power off Crosser Generator or unplug from power receptacle. 14) Never activate the Crosser Generator without a Crosser Catheter attached to the Transducer. 15) Store in a cool, dry, dark place. Rotate inventory so that the catheters and other dated products are used prior to the Use By date. 16) This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices particularly those with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. 17) Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes. 18) After use, this product may be a potential biohazard. Handle and dispose of inaccordance with acceptable medical practices and applicable local, state and federal laws and regulations. Adverse Effects: As with most percutaneous interventions, potential adverse effects include: Bleeding which may require transfusion or surgical intervention Hematoma Perforation Dissection Guidewire entrapment and/or fracture Hypertension / Hypotension Infection or fever Allergic reaction Pseudoaneurysm or fistula Aneurysm Acute reclosure Thrombosis Ischemic events Distal embolization Excessive contrast load resulting in renal insufficiency or failure Excessive exposure to radiation Stroke/CVA, Restenosis, Repeat catheterization / angioplasty Peripheral artery bypass Amputation Death or other bleeding complications at access site. Flowmate Injector Indications for Use: The Flowmate Injector is indicated for use as a sterile saline injector for use as an accessory to the Crosser Recanalization System. Refer to the Crosser Generator and the Crosser Catheter Instructions for Use for complete system operation and interventional use procedure. Warnings and Precautions: The FlowMate Injector should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA). WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING: No modification of this equipment is allowed. WARNING: Risk of injury or death to operator or patient can result from unauthorized modification to FlowMate Injector. Note: Position FlowMate Injector to allow easy access to separable power cord during use. Prior to use, the FlowMate Injector, Foot Switch and all connection to power and the Crosser Generator should be inspected for signs of damage. Never use damaged components. Contact the manufacturer for a replacement or servicing. The FlowMate Injector is intended to be used with sterile normal saline only. Do not use the FlowMate Injector with contrast media. Explosion Hazard: Do not use in the presence of flammable anesthetics. Electrical Shock Hazard: Do not attempt to service FlowMate Injector or Foot Switch. Contact manufacturer for servicing requirements. The Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked Hospital Only or Hospital Grade. Grounding reliability cannot be achieved by connecting the system to a Multiple Portable Socket-Outlets (MPSO power strip) or extension cord. In the event of a power outage or power interruption, run through the set-up procedures. The FlowMate Injector is designed to prevent operation following such events until the set-up procedures are repeated. This FlowMate Injector generates, uses, and can radiate radio frequency energy and should only be used and installed according to these instructions for use. Position Foot Switch and cable to minimize potential tripping hazard. Ensure FlowMate Injector is securely mounted to a 5 caster IV pole with minimum caster diameter of 7.62cm (3 inches) and a minimum base diameter of 55.9 cm (22 inches), no higher than 1.3 meters (51 inches) off the ground. The FlowMate Injector should not be mounted above the Crosser Generator. Should high frequency vibration or saline infusion fail to stop when Foot Switch is released, power FlowMate Injector/Crosser Generator OFF or unplug from power receptacle. Do not reuse disposable items. Dispose of per normal hospital procedures. Air Embolism Risk: to minimize air embolism risk, make certain the operator is trained on proper syringe loading techniques. Before injecting, be sure to clear air trapped in the syringe, infusion line and the Crosser Catheter. Do not introduce the Crosser Catheter into the patient until all air has been purged from the infusion line and the Crosser Catheter. A steady stream of saline exiting from the tip of the Crosser Catheter will be observed once all air has been purged. Crosser Generator Indications: The Crosser Recanalization System is indicated to facilitate the intraluminal placement of conventional guidewires beyond chronic total occlusions. The Crosser Generator is intended for use only with the Crosser Catheter. Refer to the Crosser Catheter Instructions for Use. Warnings and Precautions 1) The Crosser Recanalization System should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA). 2) Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 3) Warning: No modification of this equipment is allowed. 4) Warning: Risk of injury or death to operator or patient can result from unauthorized modification to Crosser Generator. 5) Note: Position Crosser Generator to allow easy access to separable power cord during use. 6) Prior to use, the Crosser Generator, Foot Switch and Transducer should be inspected for signs of damage. Never use damaged components. Contact manufacturer for a replacement. 7) The Crosser Generator is not protected against the ingress of fluids (IPX0). Do not place fluids above or on the Crosser Generator as damage to the Crosser Generator or shock may result. 8) Explosion Hazard: Do not use in the presence of flammable anesthetics. 9) Electrical Shock Hazard: Do not attempt to service Crosser Generator, Foot Switch or Transducer. Contact manufacturer for servicing requirements. 10) In the event of a power outage, power interruption, or system reset, replace Crosser Catheter before restarting recanalization procedure. 11) This device generates, uses, and can radiate radio frequency energy and should only be used and installed according to these instructions for use. 12) DO NOT activate the Crosser Recanalization System without proper irrigation. Make sure to establish proper irrigation prior to introduction into guide catheter. 13) Do not exceed 5 minutes of activation time as Crosser Catheter malfunction may occur. If the 5 minutes of activation time is achieved, exchange the device for a new Crosser Catheter before resetting the Crosser Generator. 14) Position Foot Switch and cable to minimize potential tripping hazard. 15) Ensure Crosser Generator is securely mounted to a 5 caster IV pole with minimum caster diameter of 7.62cm (3 inches) and a minimum base diameter of 55.9cm (22 inches) no higher than 1.5 meters off the ground. 16) Should high frequency vibration fail to stop when Foot Switch is released, power Crosser Generator OFF or unplug from power receptacle. 17) Keep out of reach of patients. The Crosser Generator must be at least 1.5 meters away from the patient. Caution! The unit is equipped with an exhaust vent. Do not block the openings or internal heat build-up may occur, causing heat build-up or damage to the equipment. MicroSheath XL, and Usher Support Catheters Indications: The MicroSheath XL and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. Contraindications: The MicroSheath XL, and Usher Catheters are contraindicated for use with Cutting/Scoring Balloons, pediatrics, neonatal and neurovascular. Warnings and Precautions: 1) Prior to use, the packaging and product should be inspected for signs of damage. If the package is opened or damaged, DO NOT use product. 2) The MicroSheath, MicroSheath XL, and Usher Catheters are intended for one procedure, single patient use only. 3) DO NOT resterilize, reprocess, or reuse it. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness, or death. Reuse, reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. 4) Store product in a dry, dark, cool place. 5) Product is non-pyrogenic unless package is opened or damaged. 6) The MicroSheath, MicroSheath XL, and Usher Catheters should only be used by physicians trained in percutaneous intravascular techniques and procedures. 7) Never advance, withdraw or manipulate the product without proper fluoroscopic guidance. Movement of the product without fluoroscopic guidance may result in damage to the product, vasculature or vessel perforation. 8) Torquing a product against resistance may cause damage to the product. Never push, withdraw or torque a catheter which meets resistance. 9) Flush the catheter when inserting and removing the product to prevent air from entering catheter system. 10) Prior to use and when possible during the procedure, inspect the product carefully for bends, kinks or damage. DO NOT use a product which is damaged. 11) Verify compatibility of the product s inner and outer diameters with other devices before use. 12) The product has only been biocompatibility tested for limited contact duration <24 hours. 13) Refer to package label for tip shape for the MicroSheath XL and Usher Catheters. Potential Adverse Events: Use of the MicroSheath, MicroSheath XL, and Usher Catheters may give rise to the following complications: Hemorrhage Hematoma Ischemia Allergic reaction to contrast medium Infection Embolism Vessel perforation/dissection Vascular occlusion Thrombosis Vessel erosion Spasms Puncture site hematoma Pain and tenderness Porter Guidewire Indications: The Porter Guidewires are intended for use in the coronary and peripheral vasculature. Contraindications: The Porter Guidewire is not intended for use in the cerebral vasculature. Patients judged not acceptable for percutaneous intervention. (PCI) Precautions: Failure to follow the instructions may compromise guidewire performance and result in complications. Prior to use, confirm compatibility of guidewire outer diameter with the balloon catheter. The tip section of the guidewire has a proper orientation for shaping. Identify the flexing plane before shaping. Shape in the same plane as that for flexure. Guidewire advancement, withdrawal, and torquing should be monitored by fluoroscopy. These guidewires have stiff distal ends. Therefore the risk of perforation or injury when using these wires is higher. These wires must be operated carefully. Use the most flexible guidewire that will treat the lesion i.e. the guidewire with the smallest flexibility number and take due care to minimize the risk of perloration or other damage to the blood vessels. Warning: A guidewire is a delicate instrument and must not be advanced, withdrawn, or torqued if resistance is met. Guidewire manipulations must always be observed under fluoroscopy. Ifthe guidewire is removed and is to be re-inserted, it must be inspected for signs of damage (weakened or kinked segments) prior to re-introduction. Do not re-introduce if guidewire is weakened or kinked. Seeker Crossing Support Catheter Indications for Use: The Seeker Crossing Support Catheters are recommended for guidewire exchange and infusion devices designed for use in the peripheral vascular system. The catheters are intended to support a guidewire during access into the vasculature, allow for guidewire exchanges, and provide a passage for delivery of saline solutions and/or diagnostic contrast agents. Contraindications: None known. Warnings: 1) Contents supplied STERILE using ethylene oxide (EO). Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Single patient use only. Do not reuse, reprocess or resterilize. 2) This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices particularly those with long and small lumina, joints, and/ or crevices between components are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. 3) Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/ or mechanical changes. 4) When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. 5) While retracting the catheter, if resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip breakage or catheter separation. 6) After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations. 7) Exceeding the maximum injection pressure of 300 psi may result in catheter failure. Precautions: 1) Carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. 2) The Seeker Crossing Support Catheter shall only be used by physicians trained in the use of vascular diagnostic catheters. 3) The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the crossing support catheter through a smaller size introducer sheath than indicated on the label. 4) Only use guidewires of the recommended diameter as noted on the packaging. 5) Flush catheter with sterile saline until saline is seen exiting distal tip. 6) If resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the catheter, introducer sheath and guidewire (as necessary) as a single unit. 7) Do not continue to use the catheter if the shaft has been kinked. 8) Prior to re-insertion through the introducer sheath, wipe the catheter clean with wet gauze, flush with sterile saline, and check the tip for damage and kinking. 9) Rotate inventory so that the catheters and other dated products are used prior to the Use By date. 10) If the catheter is to be used as an infusion catheter, reference Table 2 to ensure proper infusion rates/pressures are utilized and not exceeded. Potential Adverse Reactions: The complications which may result from a crossing support catheter procedure include: Vessel dissection, perforation, rupture or total occlusion Embolism Hypotension/hypertension Hemorrhage or hematoma Infection Vessel Spasm Distal embolization of thrombotic or atherosclerotic material Death Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions and instructions for use. Bard, Crosser, FlowCardia, FlowMate, MicroSheath, Porter, Seeker and Usher are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. All other trademarks are the property of their respective owners. Copyright 2012, C. R. Bard, Inc. All Rights Reserved. S Rev 0 Bard Peripheral Vascular, Inc W. 3rd Street Tempe, AZ USA Tel: / Fax: /