How To Use An Ekosonic Endovascular System

Transcription

1 EkoSonic Endovascular System Nursing Presentation Imagine where we can go. Imagine where we can go.

2 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 and EkoSonic are registered trademarks of EKOS Corporation, a BTG International group company. Acoustic pulse thrombolysis is a trademark of EKOS Corporation. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. Imagine where we can go. is a trademark of BTG International Ltd. 2

3 EkoSonic Endovascular System Infusion Catheter Ultrasonic Core Central Coolant Lumen Therapy Optimization Sensor Drug Lumen Ultrasound Core in Central Lumen Features 5.4 Fr catheter 106 and 135 cm working length 6, 12, 18, 24, 30, 40 and 50 cm treatment zones 3

4 EkoSonic Endovascular System FDA clearance The EkoSonic Endovascular System is indicated for: controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature infusion of solutions into the pulmonary arteries the ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism

5 What it does The EkoSonic Endovascular Device is placed into the thrombosed vessel by a physician. The patient will go to the nursing unit to be monitored. The EkoSonic Endovascular System simultaneously delivers low energy, high frequency (2.2 Mhz) ultrasound and drug along the entire treatment zone of the infusion catheter (6-50cm.) Time to clot lysis is dramatically reduced. 5

6 Acoustic Pulse Thrombolysis Treatment of Peripheral Arterial Occlusions, Deep Vein Thrombosis, and Pulmonary Embolism PAO DVT PE Acoustic Pulse Thrombolysis treatment is a minimally invasive system for accelerating thrombus dissolution. 6

7 Acoustic Pulse Thrombolysis Treatment Mechanism of action Fibrin Separation Non-cavitational ultrasound separates fibrin without fragmentation of emboli Active Drug Delivery Drug is actively driven into clot by Acoustic Streaming Fibrin without Ultrasound Fibrin With Ultrasound Acoustic streaming drives lytic into clot Braatan et al. Thrmob Haemost 1997;78: Francis et al. Ultrasound in Medicine and Biology, 1995;21(5): Soltani et al. Physics in Medicine and Biology, 2008; 53: Acoustic Pulse Thrombolysis treatment is a minimally invasive system for accelerating thrombus dissolution. 7

8 How it works Reversibly changes fibrin structure Unwinds fibrin stands Enhances transport into fibrin bundles - Ultrasound creates a pressure wave that drives drug into the permeable clot - Constant infusion of fresh drug Enhanced clot dissolution, not disruption 8

9 EkoSonic Control System Components EkoSonic Control Unit Connector Interface Cable (CIC) Battery Backup with Cart Features Controls and monitors power output and temperature of the ultrasound transducers Auto-regulates power to maximize ultrasound benefit while maintaining a safe temperature Monitors connection integrity and operating parameters Displays average power output which may indicate a change in blood flow 9

10 EkoSonic Endovascular Device Drug Port Coolant Port Components Infusion Catheter Ultrasonic Core If using two devices and two control units ensure the black and gray pair of wires from one device is connected to the same (CIC) Connector Interface Cable. 10

11 Drug (Lytic) and Coolant Ports Use your hospital infusion pump to: Infuse lytic through the drug port Infuse Heparinized Saline or Normal Saline through the Coolant port Do not aspirate from either port or piggy back any other solutions. Solutions to the side port of the sheath are at the discretion of the physician. 11

12 Infusion Catheter Fits through a 6F sheath Central lumen accommodates a in. guide wire and, later, the ultrasonic core Coolant flows through central lumen and out the distal end hole Thermocouples monitor temperature Drug flows through drug lumen and out the side holes Cross Section 12

13 Drug and Coolant Delivery NEVER ASPIRATE FROM THE DRUG LUMEN. ONLY INFUSE SOLUTIONS THE PHYSICIAN HAS SPECIFICALLY PRESCRIPBED FOR THE DRUG PORT! NEVER INFUSE ANYTHING THROUGH THE COOLANT PORT EXCEPT HEPARINIZED OR NORMAL SALINE! Due to the microscopic holes in the drug delivery catheter: Maximum flow through Drug Lumen is 35 ml/hr Please adjust your drug concentrations accordingly In order to insure optimum temperature monitoring of the ultrasound transducers: Minimum flow through the Coolant Lumen is 35 ml/hr. Maximum is 120 ml/hr Coolant should be heparinized Normal Saline or Normal Saline at room temperature and exits at the DISTAL end hole of the catheter. 13

14 Acoustic Pulse Thrombolysis Treatment Therapy Running Indicator Power Graph Button UltraSound Accelerated Thrombolysis Time Reset Button Time Reset Cancel Button Start Stop YELLOW LIGHT FLASHING INDICATES ULTRASOUND IS ON Intuitive Interface Acoustic Pulse Thrombolysis treatment is a minimally invasive system for accelerating thrombus dissolution. 14

15 Acoustic Pulse Thrombolysis CHART % TOTAL AVERAGE POWER or YELLOW LIGHT FLASHING EVERY HOUR TO DOCUMENT THERAPY IS RUNNING. Rising Average Power % Total Average Power Elapsed Time Start Stop YELLOW LIGHT FLASHING Therapy Running Indicator Intuitive Interface Acoustic Pulse Thrombolysis treatment is a minimally invasive system for accelerating thrombus dissolution. 15

16 Pearls of wisdom Ultrasound turns off AUTOMATICALLY with any alarm condition and must be MANUALLY RESTARTED Troubleshooting icons appear at the bottom of the screen. Battery is good for 1 hour. Please keep plugged in during use and storage. (takes 4 hours to charge if it runs out) May press the STOP button to pause ultrasound during doppler checks or any diagnostic ultrasound exam. Do not stop infusions. Restart ultrasound when the exam is completed. ALWAYS press the STOP button to turn off ultrasound before removing the catheter 16

17 EkoSonic Endovascular System Alarms View Troubleshooting icons at the bottom of the screen. Find solutions to alarms in the Instructions For Use manual located in the back pocket of the EKOS cart or call the 24/7 Helpline whenever needed. 1 (888) After the issue is resolved press the GREEN start button. Make sure the YELLOW light is flashing. 17

18 EkoSonic Catheter In place Follow up Angiogram demonstrating complete lysis. A. Mortarjeme, MD 18

19 24/7/365 Support 1 (888)