selectra telescopic cs lead delivery system biotronik cardiac rhythm management cardiac...
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SelectraTelescopic CS Lead Delivery System
BIOTRONIK
Cardiac Rhythm Management
Cardiac Resynchronization Therapy
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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
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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.
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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
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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
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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
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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
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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
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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
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A variety of configurations
Eight curve shapes adapt to different patient coronary sinus anatomies
Available in 45 cm and 55 cm lengths
Unique handling
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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
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Selectra “BIO2”
For CS approach from above
Support
Medium, from vena cava superior
Shape similar to
SJM CPS Direct SL MP
Reach
Less
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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
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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
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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
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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
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Selectra “Hook”
For CS approach from above
Support
Medium, from VCS
Shape similar to
SJM CPS Direct SL 135°
Reach
Medium
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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
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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
Cardiac Rhythm Management
Cardiac Resynchronization Therapy
Handling Tips & Tricks
Selectra Hemostatic Valve Design- INTERNAL EDUCATION ONLY -
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INTERNALEDUCATION
ONLY
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 closed Valve open
Insertion of tools open the back-pressure valve
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INTERNALEDUCATION
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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.
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INTERNALEDUCATION
ONLY
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
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INTERNALEDUCATION
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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
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INTERNALEDUCATION
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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.
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INTERNALEDUCATION
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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
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INTERNALEDUCATION
ONLY
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
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INTERNALEDUCATION
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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.
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INTERNALEDUCATION
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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
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INTERNALEDUCATION
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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
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INTERNALEDUCATION
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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
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INTERNALEDUCATION
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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
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INTERNALEDUCATION
ONLY
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
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INTERNALEDUCATION
ONLY
Please treat this information confidentially!
If you have any further questions or comments please do not hesitate to contact
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