ANGIODROID User Manual Dec 2013

Contents 1- Angiodroid: The CO² Injector 2 - Angiodroid: business opportunities 3 - Interventional Peripheral Angiography 4 - Carbon Dioxide: Gas Properties 5 - CO2 Indications & Applications 6 - How it works 7 - The Market: Overview 8 - Clinical validation and scientific resources 9 - Carbon Dioxide Toxicity Analysis 10 - Certification 11 - Brochure 12 - CO2 Imaging 13 - Carbon Dioxide Procedures - Video 14 - Carbon Dioxide History 15 - Angiodroid: conclusion

Angiodroid: The CO² Injector

Is a CO2 Contrast Media Injector dedicated to Interventional and Diagnostic Angiographic Peripheral Procedures

Angiodroid: Main Fields of Application

has 3 main Fields of Application  Interventional Radiology

 Vascular Surgery  Interventional Cardiology

Angiodroid: conclusion

Carbon Dioxide (CO²) is the only Safe Contrast Agent for patient with  Hyper sensibility to Iodinated Contrast Material  Renal Failure  Diabetic Diseases

Angiodroid: conclusion

Is the only Device Worldwide on Market  100% DIGITAL  100% AUTOMATIC  100% SAFE

 100% USER FIENDLY

Angiodroid: Business Opportunities

ROID: business opportunities Single-use Kit connection line + 4 Frenchs Catheter

Angiodroid The Injector

After sale services - Periodical maintenance - CO2 cylinder substitution

Interventional Peripheral Angiography • Rising life Expectancy

• Increment of vascular diseases • Development of sophisticated radiological interventional techniques

All those Aspects have determined an increment of Angiographic Procedures

CIN – Contrast Induced Nephropathy Contrast-Induced Nephropathy (CIN) Each angiographic procedure requires the injection of iodinated contrast media that, in an increasing number of procedures, has aspects of clear contraindications or quantitative limitation: the case of diseases associated with impaired renal or diabetic vascular dysfunctions.

Contrast-Induced Nephropathy (CIN) is a form of Acute Renal Failure caused by exposure to contrast media during cardiology and radiology cathetering procedures. The lack of effective treatment to prevent CIN remains problematic for patients with renal-insufficiency.

CIN – Contrast Induced Nephropathy What are the potential consequences? CIN is associated with increased: • Major adverse in-hospital cardiac events • In-hospital mortality rates • Long-term mortality • Risk of acceleration toward end-stage renal disease (dialysis) • Longer and more frequent hospital stays

According to “Marenzi, et al”, hospitalized patients who received contrast media and who acquired CIN had significantly higher mortality rate (31% vs. 0.6%) than patients who did not acquire CIN.

CIN risk incidence: 30%

higher health care costs

CO2 as Solution to CIN Risk An alternative to the use of iodinated contrast media is represented by Carbon Dioxide (CO2), a gas injected into the vessels results in a clear contrast effect and is easily removed from the circulation via the lungs. In the '70s, Hawkins was the pioneer in the US of CO2 angiography for high risk patients with intolerance to iodine or renal failure. With the advent of image subtraction angiography in 1980, the use of lowdensity CO2 became possible, and then, through the implementation of digital technologies for image subtraction, angiography with CO2 became an applicable method in the different fields of angiography.

CO2 and Iodine angiography venograms comparison

CO2

Iodium

Carbon Dioxide: Gas Properties Gas Properties: • • • • • • •

Highly compressible 20 times more soluble than O² Non Viscous and Buoyant Invisible, Colourless and Odourless Radiopacity Rapidly dissolving in Blood Lacks both Allergic Potential & Renal Toxicity

Next:  CO² doesn’t mix with Blood  It has extreme diffusibility  None Total Maximum dosage

CO2 angiography: critical issues Basically there are 3 critical issues in the use of CO2 as a contrast medium: 1. to determine the amount of injected gas and to remove the air from all over the system, in order to avoid the risk of vascular emboli 2. to inject the gas at controlled pressure in order to avoid vessel rupture in the presence of obstructions (aneurysms) 3. to properly modulate the gas injection; in order to ensure emptying of the catheter from the internal fluid, at an early stage, and to avoid the "jet“, while controlling the gas injection in a second stage

The technological solutions available up to today (see The Market: Overview), do not solve these critical issues by relying on manual control of the operator or neglecting the variability of blood pressure during the injection phase. In fact the amount of gas injected through a syringe of known volume depends on the pressure inside the vessel which is not constant over time.

CO2 Angiography Indication Indications • renal failure diabetes • intolerance to iodinated contrast •creatinine greater than 1.8 mg / dl

Contraindications • above diaphragm arterial studies • pulmonary insufficiency, pulmonary AV malformation • interauricolar or interventricular communication Possible side effects • nausea • pain • dizziness • tachycardia

CO2 Clinical Application Diagnosis applications: • pelvic arteries • lower extremity • renal, visceral, venous studies Interventional applications:

• angioplasty • stent placement • shunt for hemodialysis • vena cava filter placement • ablation of renal artery • transcatheter embolization • endovascular treatment of abdominal aortic aneurysm

How it works Injection Technique and Imaging 1. Use of Closed Circuit 2. Pressure and Volume Control System 3. Selective Injection 4. Use of Nitro-glycerine (0,1 mg) for Blood low range Patients 5. Wasteless Diet to eliminate interferences 6. Administer Buscopan (20 mg) to reduce bowel movement 7. 3-4 frames/sec Imaging Acquisition and 60 ms 8. Use Fluoroscopy mode 9. Wait 1-2 min between different injections 10. Use “stacking” software during Post processing 11. Trendelemburg modality while delivering (10° -15°)

How it works

Peripheral Angiography PTCA Endoprostesys

The Market: Overview

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ANGIOFLUSH III fluid collection system

• manual injection kit • operator-dependent: no procedural repeatability

The Market: Overview CO2 ANGIOSET • manual injection kit

• difficulty of achieving the desired injection volume

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