Acoustic Pulse Thrombolysis Treatment In-Service Presentation Acoustic Pulse Thrombolysis treatment is a minimally invasive system for accelerating thrombus dissolution.
FORWARD-LOOKING STATEMENT This presentation and information communicated verbally to you may contain certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of BTG plc ( BTG ). These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Nothing contained in this presentation or communicated verbally should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. BTG undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances. Neither this presentation nor any verbal communication shall constitute an invitation or inducement to any person to subscribe for or otherwise acquire securities in BTG. EKOS, EkoSonic and Acoustic Pulse Thrombolysis are trademarks of EKOS Corporation, a BTG International group company. EKOS and EkoSonic are registered trademarks in the EU, US and certain other territories. BTG, the BTG roundel logo and Imagine where we can go, are trademarks of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks in the US, EU and certain other territories. 2
Indications The EkoSonic Endovascular System is CE Marked for the treatment of pulmonary embolism with a 50% clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure 25 mmhg) or echocardiographic evaluation. The EkoSonic Endovascular System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. Contraindications: Not designed for peripheral vasculature dilation purposes. This system is contraindicated when, in the medical judgment of the physician, such a procedure may compromise that patient s condition. Such conditions include but are not limited to: Tortuous vascular anatomy compromising safe introduction of endovascular equipment Conditions associated with increased risk of bleeding. See device instructions for use for complete prescribing information. http://www.ekoscorp.com/6084-001_h_ifu,%20control%20unit,%20ekosonic%20with%20mach4e%20software%20(english).pdf http://www.ekoscorp.com/fall2013/mach4,%205.4f%20peripheral%20(english).pdf http://www.ekoscorp.com/fall2013/6225001_e_ifu%20ekosonic%20mach4,%205.4f%20pa%20(english).pdf http://www.ekoscorp.com http://www.ekoscorp.com/press%20releases/2014%2005%2023%20pe%20510k%20final%205-22.pdf 3
EKOSONIC ENDOVASCULAR DEVICE 4
EkoSonic Device Procedure Obtain access per standard endovascular techniques 6F introducer sheath is preferred For contralateral approach use a long supportive sheath. 5
EkoSonic Device Procedure Select the proper treatment zone length based on the length of the clot: 106cm working length: 6, 12, 18, 24, 30, 40, 50cm treatment zones 135cm working length: 12, 30, 40, 50cm treatment zones 6
Device Preparation Pearls Prepare and place the EkoSonic Device per the Instructions for Use DO NOT get the electrical connectors wet during preparation and placement. DO prep the drug lumen of the EkoSonic device with heparin (fill volume is 0.8ml to 1.0ml) and lock with a stopcock. Beware of heparin concentration and total dose NEVER draw blood back into the drug lumen. The micro pores will be blocked and the device will not infuse 7
Device Prep Select treatment zone and catheter length. Box contains two packages. (1) Infusion Catheter (1) Ultrasonic Core Isolate the electrical connectors of the device prior to flushing to ensure they stay dry. IF THE CONNECTORS GET WET, THE DEVICE WILL NOT FUNCTION PROPERLY 8
Ancillary Supplies (2) 3-Way Stopcocks or flow switches: -(1) COOLANT port -(1) DRUG port (1) 3 or 5cc syringe to flush the Drug port. Remove Infusion catheter from the tray and place a stopcock or flow switch on the DRUG port and one on the COOLANT port. 9
Infusion Catheter Flush the DRUG port with heparin using a 3 or 5cc syringe until fluid exits the most distal perfusion pores. Turn stopcock OFF to the catheter to keep air from being introduced into the vasculature. NEVER DRAW BACK BLOOD INTO THE DRUG LUMEN OR INFUSE ANYTHING BUT HEPARIN, SALINE or DRUG THROUGH THE DRUG LUMEN. IF THE MICRO PORES BECOME BLOCKED, THE INFUSION CATHETER MUST BE REPLACED. 10
Infusion Catheter Flush COOLANT port with heparinized saline. Fluid will exit the central guidewire lumen. Place your finger over the central lumen and continue to flush until you see fluid exit the distal tip of the catheter. Turn stopcock OFF to the catheter to keep air from being introduced into the vasculature. 11
Ultrasonic Core Isolate the black electrical connector of the Ultrasonic Core DO NOT GET THIS CONNECTOR WET Flush protective coil with heparinized saline to moisten the Ultrasonic Core until ready for use or wipe with a wet 10 x 10 prior to inserting into the Infusion Catheter. 12
Ultrasonic Core Platinum marker band Infusion Catheter Specific design performance driven micro transducer (Actual size comparison with dime) EkoSonic Endovascular Device Cross section of the Infusion catheter Drug Delivery Lumens Therapy Optimization Sensor Central Coolant Lumen Ultrasonic Core in Central Lumen 13 13
Procedure Place Infusion Catheter (IDDC) through a 6FR sheath over an 0.035 exchange length guide wire. Position the distal marker on the catheter 1 cm beyond the clot Remove 0.035 guidewire Flush the guide wire lumen Insert Ultrasonic Core (MSD) into the guidewire lumen and luer lock it to the Infusion Catheter manifold. 14
Ultrasonic Core Insert Ultrasonic Core in 1cm increments to prevent kinking or bending Luer lock Ultrasonic Core into the hub of the Infusion catheter WARNING: IF AN INFUSION CATHETER OR ULTRASONIC CORE BECOME KINKED OR OTHERWISE DAMAGED DURING USE, DISCONTINUE USE AND REPLACE. 15
BEGIN FLUID INFUSION Consider using sterile extension tubing to begin infusions before breaking down the sterile field. Infuse Heparinised Saline or Normal Saline through the COOLANT port at 35 ml/hr. (Max 120 ml/hr) Infuse Lytic through the DRUG port at a prescribed dose with a flow rate range from 5ml to 35ml/hr. 16
EkoSonic Control Unit Locate the power switch on the back of the control unit. Turn on the control unit. Wait for self test screen to disappear 17
Connect Cables Schematic screen appears with RED circles. Connect cables to the Connector Interface Cable (CIC). Black to Black, Gray to Gray, and symbols OO. MAKE SURE THE ULTRASONIC CORE and INFUSION CATHETER CABLES ARE A PAIR IN THE PATIENT. CROSS CONNECTING AN ULTRASONIC CORE AND INFUSION CATHETER FROM 2 DIFFERENT PAIRS COULD RESULT IN PATIENT INJURY. 18
Catheter Connector Clip Prevent disconnection alarms by using the catheter connector clip 19
EkoSonic Endovascular System Confirm connections on the schematic screen. (Red circles will disappear). Confirm fluids are infusing. Press GREEN START button Confirm YELLOW light is flashing 20
ACOUSTIC PULSE THROMBOLYSIS Therapy Running Indicator Screen Selector Button Time Reset Button Start Stop Cancel Button Yellow Light Flashing Intuitive Interface Acoustic Pulse Thrombolysis treatment is a minimally invasive system for accelerating thrombus dissolution. 21
ACOUSTIC PULSE THROMBOLYSIS Rising Average Power Instantaneous Average Power Elapsed Time Start Stop Therapy Running Indicator Intuitive Interface Acoustic Pulse Thrombolysis treatment is a minimally invasive system for accelerating thrombus dissolution. 22
Secure Device Secure device with tegaderm, steri-strips, or tape. Refrain from coiling the catheter too severely. Move patient onto a bed or stretcher. Inform the patient that they will be on bed rest and will have to keep the affected extremity straight at the insertion site and treatment zone. 23
Transport Turn off Ultrasound using the ORANGE stop button Turn the rocker switch to OFF on the back of the control unit Unplug the EKOS system from the outlet (a preferred power break electrical socket) Transport patient. Plug the EKOS system into an outlet (a preferred power break electrical socket) Turn the rocker switch to ON on the back of the control unit Push the GREEN START button to activate therapy Confirm the YELLOW light is flashing. Place the Control Unit on a flat and steady surface (for instance a large bedside table). Set the collapsible legs to be certain air can circulate freely to the fan underneath the Control Unit. 24
Removal of the EkoSonic Endovascular Device ALWAYS turn off the ultrasound by pressing the ORANGE STOP button before removing the Ultrasonic Core from the Infusion Catheter If the Ultrasonic Core is removed while running, it will turn off automatically, but in the few seconds it takes to turn off, it can become very hot. Decontaminate the Ultrasonic Core and Infusion Catheter while prepping the patient for recheck Remove the Ultrasonic Core from the Infusion Catheter Insert a guidewire through the Infusion Catheter and remove as one or leave guidewire in place while removing Infusion Catheter Angiography may be performed to assess the treatment site. WARNING: NEVER connect Infusion Catheter to a power injector. 25
Alarms For Disconnect: Press the Mute button in the top right hand corner of the control unit Confirm reason for alarm as indicated by the RED circle. Make correction. Activate ultrasound by pressing the GREEN START button. 26
Alarms General Alarm: MUTE alarm Locate alarm icon blinking at the bottom of the screen between the two gray bars. Locate explanation for icon in the IFU, call your local rep or call the 24/7 EKOS Helpline. Follow IFU or helpline suggestions. Restart ultrasound by pressing the GREEN button. 27
If you are unable to resolve the problem Contact your local EKOS representative, or Call our helpline on +1-888-356-7435 (please note that helpline conversations are only available in English) Please record any displayed icons before calling.