Affera Mapping & Ablation System
Turner Dubler, BSN, RN November 6th, 2025
INDEX
01 · AF and the need for solutions
02 · PFA ablation technology
03 · Affera
04 · Sphere-9
05 · Prism-1
06 · Affera Vs Competitors
09 · Contact
07 · Physician Testimonial
08 · Summary
The Epidemic of Atrial Fibrillation
AF is the most common clinically significant cardiac arrythmia
AF predisposes patients to adverse health outcomes
AF affects 1 in 3-5 adults over the age of 45
+ INFO
+ INFO
+ INFO
Ablative Therapy
Why discrete RF & PFA solutions fall short
RF thermal energy, while capable of greater precision in lesion creation than PFA, carries the inherent risk of damaging non-cardiac structures leading to serious complications including esophageal injury, pulmonary vein stenosis, and phrenic nerve palsy.
PFA utilizes short, high-voltage electrical pulses to induce cell death via electroporation of cardiac cells. It is cardiac selective and non-thermal, thus avoiding the risks posed by radiofrequency ablation techniques.
Affera's Sphere-9 catheter mates the point-by-point precision of RF ablation with the safety profile of PFA in a revolutionary catheter design.
Introducing the Affera System
An all-in-one solution that maps, ablates, and validates using both RF & PFA energy.
Sphere-9 Catheter
Prism-1 Mapping Software
Sphere-9
Safe, efficient, versatile.
the science of current density
The Sphere-9 lattice acts as a solid electrode capable of delivering significantly higher overall current while maintaining lower current density, leading to deeper, more evenly-distributed lesions with significantly lower risk than smaller electrodes.
Less than 11 minutes to create high-density maps with greater than 5000 points.
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Why Sphere-9 beats the PFA competition
Farapulse & Trupulse
Sphere-9
Capable of both PFA and RF lesions
Single-shot basket/coil design
Mapping, ablating and validating all with a single catheter.
Requires an additional catheter for mapping
Delivers point-by-point ablation with large, uniform lesions enabled by low current density RF.
Unable to perform point-by-point ablation
Limited to PFA only
PFA energy is immediately available and requires no recharge time.
PFA energy requires significant recharge times.
Key Differentiator #1: Dual Energy Sources
Sphere-9
Farapulse, Trupulse, STSF
Seamlessly transition between RF and PFA.
Limited to one energy modality.
Enables physician to easily address latent arrythmias such as atrial flutter or AVNRT that are often not identified prior to procedural observation.
Limited to either single-shot design or narrow, small lesion focal ablation.
RF lesions benefit from lower current density and therefore are capable of delivering higher overall current and forming large, consistent and deep RF lesion sets.
Differentiator #2: Integrated, HD Mapping & Validation
Sphere-9
Farapulse, Trupulse, STSF
Zero-exchange workflow
Multiple exchange workflow
Fewer catheters and exchanges translates to faster case times
Lesion set validation dependent on mapping catheter exchange, adding time and additional risks to the procedure
Physicians can map, ablate, and validate iteratively and rapidly
Differentiator #3: Precise, Rapid Focal PF & RF Ablation
Physician Testimonial
Affera makes the procedure faster and safer while maintaining excellent clinical outcomes.
Results from SPHERE Per-AF IDE Trial
Map
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Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh. Euismod tincidunt ut laoreet doloreadipiscing elit.
Thanks!
Turnerdubler@gmail.com
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Projection studies show that the prevalence of AF will rise to 15.9 million in 2050 in America and 17.9 million in 2060 in Europe.
According to the NIH, AF carries multiple risks, including "2-fold increase in myocardial infarction, 5-fold increase in stroke and heart failure, as well as dementia and cognitive decline." 1
Patients with AF suffer increased morbidity and mortality and incur high annual healthcare costs.
Got an idea?
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Affera Mapping & Ablation System
Turner Dubler
Created on November 3, 2025
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Transcript
Affera Mapping & Ablation System
Turner Dubler, BSN, RN November 6th, 2025
INDEX
01 · AF and the need for solutions
02 · PFA ablation technology
03 · Affera
04 · Sphere-9
05 · Prism-1
06 · Affera Vs Competitors
09 · Contact
07 · Physician Testimonial
08 · Summary
The Epidemic of Atrial Fibrillation
AF is the most common clinically significant cardiac arrythmia
AF predisposes patients to adverse health outcomes
AF affects 1 in 3-5 adults over the age of 45
+ INFO
+ INFO
+ INFO
Ablative Therapy
Why discrete RF & PFA solutions fall short
RF thermal energy, while capable of greater precision in lesion creation than PFA, carries the inherent risk of damaging non-cardiac structures leading to serious complications including esophageal injury, pulmonary vein stenosis, and phrenic nerve palsy.
PFA utilizes short, high-voltage electrical pulses to induce cell death via electroporation of cardiac cells. It is cardiac selective and non-thermal, thus avoiding the risks posed by radiofrequency ablation techniques.
Affera's Sphere-9 catheter mates the point-by-point precision of RF ablation with the safety profile of PFA in a revolutionary catheter design.
Introducing the Affera System
An all-in-one solution that maps, ablates, and validates using both RF & PFA energy.
Sphere-9 Catheter
Prism-1 Mapping Software
Sphere-9
Safe, efficient, versatile.
the science of current density
The Sphere-9 lattice acts as a solid electrode capable of delivering significantly higher overall current while maintaining lower current density, leading to deeper, more evenly-distributed lesions with significantly lower risk than smaller electrodes.
Less than 11 minutes to create high-density maps with greater than 5000 points.
Write your title here
Write your titlhere
Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore.
Why Sphere-9 beats the PFA competition
Farapulse & Trupulse
Sphere-9
Capable of both PFA and RF lesions
Single-shot basket/coil design
Mapping, ablating and validating all with a single catheter.
Requires an additional catheter for mapping
Delivers point-by-point ablation with large, uniform lesions enabled by low current density RF.
Unable to perform point-by-point ablation
Limited to PFA only
PFA energy is immediately available and requires no recharge time.
PFA energy requires significant recharge times.
Key Differentiator #1: Dual Energy Sources
Sphere-9
Farapulse, Trupulse, STSF
Seamlessly transition between RF and PFA.
Limited to one energy modality.
Enables physician to easily address latent arrythmias such as atrial flutter or AVNRT that are often not identified prior to procedural observation.
Limited to either single-shot design or narrow, small lesion focal ablation.
RF lesions benefit from lower current density and therefore are capable of delivering higher overall current and forming large, consistent and deep RF lesion sets.
Differentiator #2: Integrated, HD Mapping & Validation
Sphere-9
Farapulse, Trupulse, STSF
Zero-exchange workflow
Multiple exchange workflow
Fewer catheters and exchanges translates to faster case times
Lesion set validation dependent on mapping catheter exchange, adding time and additional risks to the procedure
Physicians can map, ablate, and validate iteratively and rapidly
Differentiator #3: Precise, Rapid Focal PF & RF Ablation
Physician Testimonial
Affera makes the procedure faster and safer while maintaining excellent clinical outcomes.
Results from SPHERE Per-AF IDE Trial
Map
Lorem ipsum dolor sit amet
Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh. Euismod tincidunt ut laoreet doloreadipiscing elit.
Thanks!
Turnerdubler@gmail.com
Got an idea?
Use this space to add awesome interactivity. Include text, images, videos, tables, PDFs... even interactive questions! Premium tip: Get information on how your audience interacts with your creation:
Got an idea?
Use this space to add awesome interactivity. Include text, images, videos, tables, PDFs... even interactive questions! Premium tip: Get information on how your audience interacts with your creation:
Got an idea?
Use this space to add awesome interactivity. Include text, images, videos, tables, PDFs... even interactive questions! Premium tip: Get information on how your audience interacts with your creation:
Got an idea?
Use this space to add awesome interactivity. Include text, images, videos, tables, PDFs... even interactive questions! Premium tip: Get information on how your audience interacts with your creation:
Projection studies show that the prevalence of AF will rise to 15.9 million in 2050 in America and 17.9 million in 2060 in Europe.
According to the NIH, AF carries multiple risks, including "2-fold increase in myocardial infarction, 5-fold increase in stroke and heart failure, as well as dementia and cognitive decline." 1
Patients with AF suffer increased morbidity and mortality and incur high annual healthcare costs.
Got an idea?
Use this space to add awesome interactivity. Include text, images, videos, tables, PDFs... even interactive questions! Premium tip: Get information on how your audience interacts with your creation:
Got an idea?
Use this space to add awesome interactivity. Include text, images, videos, tables, PDFs... even interactive questions! Premium tip: Get information on how your audience interacts with your creation:
Got an idea?
Use this space to add awesome interactivity. Include text, images, videos, tables, PDFs... even interactive questions! Premium tip: Get information on how your audience interacts with your creation: