ekosonic endovascular system nursing presentation · pdf filenothing contained in this...

EkoSonic ®

Endovascular SystemNursing Presentation

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.

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EKOS, EkoSonic and Acoustic pulse thrombolysis are trademarks of EKOS Corporation, a BTG International group company. ‘Imagine where we can go’, BTG and the BTG roundel logo are trademarks of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks in the U.S, EU and certain other territories

EkoSonic Endovascular System

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Features̶ 5.4 Fr catheter̶ 106 and 135 cm working length̶ 6, 12, 18, 24, 30, 40 and 50 cm treatment zones

Infusion Catheter

Ultrasonic Core

Central Coolant Lumen

Therapy Optimisation Sensor

Drug Lumen

Ultrasound Core in Central Lumen


– Indications

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The EkoSonic™ Endovascular System is indicated for: • 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).pdfhttp://www.ekoscorp.com/fall2013/MACH4,%205.4F%20Peripheral%20(English).pdfhttp://www.ekoscorp.com/fall2013/6225001_E_IFU%20EkoSonic%20MACH4,%205.4F%20PA%20(English).pdfhttp://www.ekoscorp.comhttp://www.ekoscorp.com/press%20releases/2014%2005%2023%20PE%20510K%20FINAL%205-22.pdf

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.

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Acoustic Pulse Thrombolysis Treatment

of Peripheral Arterial Occlusions,

Deep Vein Thrombosis, and Pulmonary Embolism

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PAO DVT

PE

Acoustic Pulse Thrombolysis™ treatment is a minimally invasive system for accelerating thrombus dissolution.

Acoustic Pulse Thrombolysis Treatment

– Mechanism of action

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Braatan et al. Thrmob Haemost 1997;78:1063-8.Francis et al. Ultrasound in Medicine and Biology, 1995;21(5):419-24.Soltani et al. Physics in Medicine and Biology, 2008; 53:6837-47.

Fibrin SeparationNon-cavitational ultrasound separates fibrin

without fragmentation of emboli

Active Drug DeliveryDrug is actively driven into clot by

“Acoustic Streaming”

Fibrin without Ultrasound

Fibrin With Ultrasound

Acoustic streaming drives lytic into clot


How it works

– Reversibly changes fibrin structure– Unwinds fibrin strands

– 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

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EkoSonic Control System

–Components• EkoSonic Control Unit• Connector Interface Cable (CIC)

–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

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EkoSonic Endovascular Device

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– 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.

DrugPort

CoolantPort

Drug (Lytic) and Coolant Ports

Use your hospital infusion pump to:• Infuse lytic through the drug port • Infuse Heparinised Saline or normal saline through the coolant port• Do not aspirate from either port or add other medications/solutions.• Solutions to the side port of the sheath are at the discretion of the physician.

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Infusion catheter

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• Fits through a 6F sheath

• Central lumen accommodates a 0.035 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

Drug and Coolant Delivery

– NEVER ASPIRATE FROM THE DRUG LUMEN. ONLY INFUSE SOLUTIONS THE PHYSICIAN HAS SPECIFICALLY PRESCRIBED 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.

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Acoustic Pulse Thrombolysis

Treatment

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UltraSound Accelerated Thrombolysis Time Reset Button

Time Reset CancelButton

Power Graph Button

Start Stop

Intuitive Interface

Therapy Running Indicator

YELLOW LIGHT FLASHINGINDICATES ULTRASOUND IS ON


Acoustic Pulse Thrombolysis

treatment

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Rising Average Power

Elapsed Time

Therapy Running Indicator

Start Stop

CHART % TOTAL AVERAGE POWER or YELLOW LIGHT FLASHING EVERY HOUR TO

DOCUMENT THERAPY IS RUNNING.

YELLOW LIGHT FLASHING

% Total Average Power

Intuitive Interface


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.

• 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

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Alarms

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• View Troubleshooting icons at the bottom of the screen.

• Find solutions to alarms in the Instructions For Use manual or call your local EKOS representative. The 24/7 Helpline is available (in English only) +1.888.356.7435

• After the issue is resolved press the GREEN start button. Make sure the YELLOW light is flashing.

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EkoSonic CatheterIn place

A. Mortarjeme, MD

Follow up Angiogram demonstrating complete lysis.

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24/7/365 SUPPORT

+1 (888) 356-7435

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