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Selectra Telescopic CS Lead Delivery System BIOTRONIK Cardiac Rhythm Management Cardiac Resynchronization Therapy.

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Presentation on theme: "Selectra Telescopic CS Lead Delivery System BIOTRONIK Cardiac Rhythm Management Cardiac Resynchronization Therapy."— Presentation transcript:

1 Selectra Telescopic CS Lead Delivery System BIOTRONIK Cardiac Rhythm Management Cardiac Resynchronization Therapy

2 1 Coronary sinus lead delivery system Selectra. The first choice. Selectra Outer Catheters A variety of advanced catheters incorporating superior and innovative features Selectra Inner Catheters Optimal vessel sub-selection for direct delivery of low profile coronary sinus leads New Selectra Slitter Tool Ergonomic design for a smooth slitting process with lead dislodgement prevention

3 2 Telescopic system with inner catheters Advanced and atraumatic soft tip design New and innovative ergonomic handle Balanced and superior shaft design A variety of configurations Coronary sinus lead delivery system Selectra. The first choice.

4 3 The ultimate handling experience Innovative design The innovative handle design allows for a smooth slitting process from every angle An integrated hemostatic valve enables effortless introduction of inner catheters or coronary sinus leads The build-in side-port enables simultaneous manipulation and contrast injection provide an extraordinary handling experience

5 4 Lubricious and balanced like no other Unique handling Superior kink resistance and sensitive torque control are achieved by smooth stiffness profiles resulting in a pushable proximal shaft and flexible distal section

6 5 The unique hydrophilic inner coating provides excellent lubricity allowing for effortless introduction of inner catheters, delivery of coronary sinus leads and system removal Lubricious and balanced like no other Unique handling

7 6 Atraumaticity matters Superior quality Round soft tip design provides high atraumaticity during CS cannulation minimizing the risk for dissections During lead manipulation, the high tip stability reduces the risk for prolapse Excellent visibility during system positioning due to highly radiopaque polymeric x-ray marker

8 7 Teamwork Superior quality The combination of Selectra outer catheters with inner sub-selection catheters enables direct delivery of low profile coronary sinus leads such as the new Sentus OTW Optimized coronary sinus cannulation and in deep-seating outer catheters due to the perfect balance of stiffness and flexibility

9 8 Superior quality Selectra inner catheters Slittable in-line luer with integrated hemostatic valve for smooth slitting procedures and ergonomic one-handed manipulation and contrast injection Hydrophilic inner coating for easy insertion of CS leads and removal of delivery system without the risk for lead dislocation 50° and 90° degree tip angulations for easy vessel sub-selection

10 9 A variety of configurations Eight curve shapes adapt to different patient coronary sinus anatomies Available in 45 cm and 55 cm lengths Unique handling

11 10 Selectra Straight For CS approach from above with EP catheter Support None Shape similar to BSX Acuity BA CS-ST MDT Attain Command Straight SJM CPS Direct SL Straight Reach None

12 11 Selectra BIO2 For CS approach from above Support Medium, from vena cava superior Shape similar to SJM CPS Direct SL MP Reach Less

13 12 Selectra Multipurpose EP For CS approach from above Support Medium, from vena cava superior Shape similar to BSX Acuity BA CS-MP MDT Attain Command MB2 SJM CPS Direct SL 115° Reach Less

14 13 Selectra Multipurpose Hook For CS approach from below Support Medium, from VCS right atrial wall Shape similar to BSX Acuity BA CS-H MDT Attain Command MP Reach Medium

15 14 Selectra Right For CS approach during right-sided implants Support Medium, from VCS Shape similar to BSX Acuity BA CS-EH ST R MDT Attain Command Right SJM CPS Direct SL Right Reach Medium

16 15 Selectra Amplatz 6.0 For CS approach when severe left heart dilatation is present Support Medium, from VCS Shape similar to BSX Acuity BA CS_A6 MDT Attain Command Amplatz Reach Medium

17 16 Selectra Hook For CS approach from above Support Medium, from VCS Shape similar to SJM CPS Direct SL 135° Reach Medium

18 17 Selectra Extended Hook For CS approach from below Support More, from VCS and right atrial wall Shape similar to BSX Acuity BA CS-EH MDT Attain Command EH SJM CPS Direct SL Wide Reach More

19 18 New Selectra slitter tool Integrated lead clip fixates the lead body during the slitting process Secure and easy slitting of the handle and the entire catheter due to optimized blade Ergonomic design allows for comfortable handling during catheter removal or continuation of the slitting process in case of slipping Unique handling

20 Cardiac Rhythm Management Cardiac Resynchronization Therapy Handling Tips & Tricks Selectra Hemostatic Valve Design - INTERNAL EDUCATION ONLY -

21 INTERNAL EDUCATION ONLY 20 The valve is designed to ensure a low friction environment for optimal lead pushability and safety during sheath removal. The valve consist of a proximal sealing ring and a distal back-pressure valve. Selectra. The first choice. Selectra hemostatic valve design Back-pressure valve Sealing ring Valve closedValve open Insertion of tools open the back- pressure valve

22 INTERNAL EDUCATION ONLY 21 Selectra hemostatic valve design update The hemostatic valve performance was continuously improved based on observations from the PME and initial market feedback. Process improvements lead to avoidance of valve prolapse during lead or catheter removal ensuring the integrity and functionality of the back-pressure valve. Short-term: The TVI with dilator is offered separately and can be used to introduce 0.14 guide wires. The dilator seals onto the guide wire and reduces back-bleeding. Medium-term: A new TVI which seals onto a 0.14 guide wire will be developed and included into the accessory kit. Recommendation: Close the proximal end of the catheter with your thumb during aspiration through the side port. Selectra hemostatic valve design.

23 INTERNAL EDUCATION ONLY 22 Use case #1 - Nothing is inserted Due to the fact that the venous blood pressure is higher than the atmospheric pressure the back-pressure valve is fully closed when nothing is inserted from proximal! Selectra hemostatic valve design. Higher pressure Lower pressure Nothing is inserted

24 INTERNAL EDUCATION ONLY 23 Use case #2 - Dilator insertion Observation: If only a dilator is inserted, back-bleeding can occur through inner lumen of the dilator because of an open system. Selectra hemostatic valve design. Dilator Back-bleeding Only dilator inserted Higher pressure

25 INTERNAL EDUCATION ONLY 24 Use case #2 - Dilator insertion (cont.) Solution: Use dilator only in combination with the 0.35 guide wire in order to close the inner lumen of the dilator! 0.35 Guide Wire Dilator Dilator and guide wire inserted Selectra hemostatic valve design.

26 INTERNAL EDUCATION ONLY 25 Use case #3 – Valve prolapse Observation: Prolapse may occur when a dilator or lead is quickly removed from the sheath pulling the flap back through valve Selectra hemostatic valve design. Higher pressure

27 INTERNAL EDUCATION ONLY 26 Use case #3 - Valve prolapse (cont.) Solution: Leakage will stop once a lead or catheter is advanced through the valve, pushing the flap back from the valve Selectra hemostatic valve design. Dilator, LV Lead or EP Catheter Insert dilator or lead

28 INTERNAL EDUCATION ONLY 27 Use case #3 - Valve prolapse (cont.) Solution: Process improvements aims to avoid the valve prolapse during lead or catheter removal ensuring the integrity and functionality of the back-pressure valve. Please note that the improvement is being introduced seamlessly into running production. Therefore you may receive products before or after the process change depending on inventory. Care should be taken to observe a potential valve prolapse and if required, to take the action recommended on the previous slide. Selectra hemostatic valve design.

29 INTERNAL EDUCATION ONLY 28 Use case #4 - Lead or EP catheter insertion The sealing ring fully seals onto a lead or EP catheter and no back-bleeding occurs! Selectra hemostatic valve design. LV Lead or EP Catheter Lead is inserted

30 INTERNAL EDUCATION ONLY 29 Use case #5 - Aspiration with syringe Observation: Aspiration can lead to lower pressure distally of the valve causing it to open slightly, which might cause air bubbles being aspirated. Selectra hemostatic valve design. Higher pressure Lower pressure Air bubbles might enter the catheter and will be directly aspirated into the syringe Aspiration through side port

31 INTERNAL EDUCATION ONLY 30 Use case #5 - Aspiration with syringe (cont.) Solution: Close the proximal end of the catheter with your thumb or sealing cap to avoid valve opening during aspiration! After aspiration the valve closes again due to the pressure change and there is no risk of air embolism for the patient! Selectra hemostatic valve design. The back-pressure valve closes due to the higher pressure inside the system! Higher pressure Lower pressure Aspiration through side port

32 INTERNAL EDUCATION ONLY 31 Use case #6 - Guide wire only insertion Observation: The sealing ring does not fully seal onto 0.14 and 0.35 guide wires if they are introduced alone, which might cause slight back- bleeding. Selectra hemostatic valve design. Guide Wire Only guide wire inserted Back-bleeding

33 INTERNAL EDUCATION ONLY 32 Use case #6 - Guide wire only insertion (cont.) Solution: If only a 0.14 guide wire is inserted use the TVI with dilator. The TVI and dilator seals onto the guide wire and centers it avoiding excessive back-bleeding. Selectra hemostatic valve design. TVI Dilator TVI Guide Wire Guide Wire and TVI with dilator inserted

34 INTERNAL EDUCATION ONLY 33 Please treat this information confidentially! If you have any further questions or comments please do not hesitate to contact matthias.wenzel@biotronik.com or oliver.helm@biotronik.com


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