1. Introduction to Catheter Based Devices Presented by: Indaka (Indi) Gunasekara Director of Catheter Development MedVenture Technology Corp. Louisville, KY

2. Brief History Catheter Types & Applications Catheterization Techniques Catheter Materials Catheter Construction Regulatory Compliance Introduction to Catheter Based Devices

3. Charles T. Dotter M.D. (1920-1985) Interventional Radiologist Pioneer in the Field of Minimally Invasive Procedures (Catheterization) Developed Continuous X-Ray Angio-Cardiography Performed First Angioplasty (PTCA) Procedure in 1964.

4. Trademark of Dr. Dotter “If a plumber can do it to pipes, we can do it to blood vessels.” Charles T. Dotter M.D.

5. Melvin P. Judkins M.D. (1922-1985) A pioneer Radiologist whos techniques are still used today in Angiography

6. Dr Andreas Gruentzig (1935 – 1985) German Physician who convinced the medical community of the safety/efficacy of PTCA by performing the procedure on himself.

7. Dr. Thomas Forgarty Inventor of the Forgarty Thrombolectomy Balloon Catheter. Recipent of more than 60 U.S. Patents for his inventions.

8. Catheter Types and Applications Diagnostic Catheters –Angiography –Electophysiology –ivus (Intravenious Ultrasound)

9. Catheter Types and Applications (continued) Therapeutic Catheters –PTCA (Percutanious Transluminal Angioplasty) –Distal Protection Devices –Dialysis –Drainage –Drug and Stent Delivery –RF Ablation

10. Catheterization Techniques Vascular / Coronary Insertion Techniques –Transfemoral Approach –Brachial (Arm) Approach

11. Catheterization Techniques Neurological Insertion Techiniques (Intrathecal Space) –Lumbar Approach –Ventricular Approach with Tunneling Other Non-Vascular Insertion Techniques –Endoscopic Assisted Placement

12. Catheter Materials (Samples) Thermoplastics: –Nylon, PET, Urethane, PE, PVC, PEEK, etc. Thermosets: –Silicone, PTFE, Polyimide, etc. Composites / Filled: –Liquid Crystal Polymers (LCP) –Radiopaque Fillers (20 to 40%) Barium Sulfate, Bismuth Oxychloride, Tantulum, etc.

13. Catheter Construction (Equipment) Extrusion Line

14. Catheter Construction (Equipment) Extruder

15. Catheter Construction (Equipment) Vacuum Tank (Sizing)

16. Catheter Construction (Equipment) Laser OD Gauge (Feedback Loop to Puller)

17. Catheter Construction (Equipment) Puller (Sizing)

18. Catheter Construction (Equipment) Steeger Braider

19. Catheter Construction (Equipment) Custom Braider

20. Catheter Construction (Equipment) Insert Molding Machine

21. Catheter Construction Lumens (Longitudinal Passages) –Single Lumen –Multi-Lumen Segmented Catheter (Multi-Durometer) –Tip (Distal) –Body –Hub (Proximal) Reinforced Wall Sections –Braided vs. Coiled

22. Tipping: –Radiused Tip Glass Tube / Two Part Cutting Dies –Tappered Tip Fenestrations (Holes): –Drilled (hollow drilling tube with knife edge) –Laser Cut Catheter Construction

23. Coatings: –Hydrophilic –Lubricious –Anti-thrombogenic –Antibiotic –Anti-coagulant (Pyralene) –Anti-fungal (Ag-N 3 ) –Liquid Silicone –Drug-eluting Stents (anti-neoplasty) Catheter Construction

24. Foley Catheter –Single lumen latex therapeutic drainage catheter Angioplasty Catheter(s) –Coaxial nylon catheter with nylon ballon therapeutic PTCA catheter –Rapid exchange catheter w/ a stainless steel balloon expandable stent loaded Catheter Examples

25. Catheter Examples (continued) Lumbar Drainage Catheter –Single lumen polyurethane catheter with an integrated nickel alloy flat wire coil (MRI compatible) Neurological Catheter –Single lumen nylon drug/adhesive delivery catheter

26. Catheter Examples (continued) Distal Protection Filter –Laser drilled urethane membrane filter at end of Guidewire Parodi System –PAEC (Parodi Anti Embolic Catheter) –PAED ( Parodi Anti Embolic Dialator) –PEB ( Parodi Embolic Balloon) –PBRS (Parodi Blood Return System) Distal Protection

27. Catheter Examples (continued) Parodi System

28. Regulatory Issues Food and Drug Admin. (FDA) Device Classifications –Class I - Devices subject to General Controls Simple with no blood contact Example: Wound dressings –Class II - Devices subject to General Controls and Special Controls Peripheral devices (non-life threatening) Examples: Forgarty thrombolectomy catheter –Class III - Devices subject to General Controls, Special Controls, and Premarket Clearance Life sustaining and permanent implants Examples: Coronary stents and pacemakers

29. Regulatory Issues Food and Drug Admin. (FDA) New Device Approval Processes: –PMA - Unique Device Without Precedence Extensive and lengthy approval process Clinical trials maybe required –510K - References Predicate Device(s) Minimal clinical data required to prove safety Shorter approval process (i.e. as little as 3 months)

30. Regulatory Issues International Organization for Standardization (ISO) ISO is a network of the national standards institutes of 148 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO standards are voluntary. As a non- governmental organization, ISO has no legal authority to enforce their implementation.

31. Regulatory Issues International Organization for Standardization (ISO) The ISO 9000 standards are primarily concerned with "quality management". –the customer's quality requirements –applicable regulatory requirements –enhance customer satisfaction –achieve continual improvement of its performance in pursuit of these objectives

32. Regulatory Issues International Organization for Standardization (ISO) The ISO 13485 is primarily concerned with “medical devices”. –Required for CE Mark –Design Dossier (Design Master/History File)

33. Valve Repair and replacement Identification and treatment of Vulnerable Plaque Stroke therapy (Ischemic and Hermoragic) Anastomosis Percutanious Bypass Grafts Localized Drug delivery for Cancer Treatment IMRI (Interoperative MRI) Thrombolectomy Drug-eluting Stents Current Trends in Catheter Technology

34. This completes my presentation. Thank you for your interest and cooperation. Indaka (Indi) Gunasekara Director of Catheter Development MedVenture Technology Corp. Louisville, KY Introduction to Catheter Based Devices