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  1. Recently-Approved Devices

Sphere‐9 Catheter and Affera Ablation System - P240013

Close up of the balloon-shaped tip of the Sphere-9 Catheter and Affera Ablation System


This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Sphere-9 Catheter and Affera Ablation System
PMA Applicant: Medtronic Inc.
Address: 8200 Coral Sea Street NE, Mounds View, MN 55112
Approval Date: October 24, 2024
Approval Letter: Approval Order

What is it?

The Sphere-9 Catheter and Affera Ablation System is used to treat irregular, fast heartbeats called atrial fibrillation and typical (or type I) atrial flutter through a procedure called catheter ablation.

The system includes a thin, flexible wire (catheter) with a tip shaped like a balloon that is made of a metal mesh, a pulsed field generator, a radiofrequency generator, an irrigation pump, a remote control, a foot pedal, catheter interface cables, connection cables, a tubing set, and power cords.

A doctor puts the Sphere-9 Catheter into a large vein in the groin through a small cut. The tip of the catheter is then moved through the blood vessels up to the heart. The doctor places the balloon tip at different locations in the heart and uses the generators to send electrical currents (either pulsed fields or radiofrequency). Pulsed fields are fast electrical pulses that cause holes to form in the thin barrier surrounding each heart cell, which causes the cells to die. Radiofrequency current causes cells to heat up and die. The dead heart cells block electrical signals that can lead to an abnormal heart rhythm (arrhythmia). After treatment, the catheter is removed.

The Sphere-9 Catheter is indicated for use to map the electrical currents in the heart (cardiac electrophysiological mapping) using stimulation and electrogram recording. It is also indicated for treatment of drug refractory recurring symptomatic persistent atrial fibrillation, which is a rapid heartbeat that causes noticeable symptoms, does not respond to medication, occurs more than once, and includes episodes lasting longer than 7 days but resolving in less than a year. Finally, when used together with the Affera Ablation System, the Sphere-9 Catheter is also indicated for radiofrequency catheter ablation treating a common heart arrhythmia called cavotricuspid isthmus dependent atrial flutter.

In a clinical study (SPHERE Per-AF) where 477 people with drug refractory, recurrent symptomatic persistent AF were selected to participate, 212 received ablation with the Sphere-9 Catheter and Affera Ablation System and 208 received ablation with the already approved THERMOCOOL SMARTTOUCH SF radiofrequency ablation catheter.

The study was designed to show that treatment with the Sphere-9 Catheter and Affera Ablation System is “non-inferior” to treatment with the already approved THERMOCOOL SMARTTOUCH SF. Results were recorded for patients who completed 12 months of follow-up after the treatment. Of the patients treated with the Sphere-9 Catheter and Affera Ablation System, 155 did not experience arrhythmia again (recur) within 12 months (73.8%). Of the patients treated with the approved THERMOCOOL SMARTTOUCH SF, 133 did not experienced recurrence within 12 months (65.8%). The Sphere-9 Catheter and Affera Ablation System met the pre-defined statistical criteria to be considered as performing as well as the control catheter (“non-inferior”).

In a later (post hoc) analysis of the study data, 115 people received cavotricuspid isthmus (CTI) ablation with the Sphere-9 Catheter and Affera Ablation System and 97 people received cavotricuspid isthmus ablation with the approved THERMOCOOL SMARTTOUCH® SF. Results were recorded for patients who completed 12 months of follow-up after the treatment.  Of the patients treated with the Sphere-9 Catheter and Affera Ablation System, 99 did not experience a recurrence within 12 months (86.8%). Of the patients treated with the THERMOCOOL SMARTTOUCH SF, 70 did not experience a recurrence within 12 months (76.9%). The results supported the use of radiofrequency ablation using the Sphere-9 Catheter and Affera Ablation System to treat CTI-dependent atrial flutter.

The Sphere-9 Catheter and Affera Ablation System should not be used in people who have:
  • A bloodstream infection (active systemic infection). The catheter may increase the risk of the infection spreading to the heart. Cardiac surgery in the 8 weeks before the procedure, as there is an increased risk of causing a hole (perforation).
  • A tumor (myxoma) or blood clot in the heart (thrombus). Use of the catheter may cause the tumor or clot to block blood flow (emboli).
  • Mechanical artificial (prosthetic) heart valves. The catheter may damage the prosthetic valve or cause the catheter to get caught (entrapment) or block blood flow.
  • Aortic valve replacement using a common access route to the heart called a retrograde trans aortic approach. The approach may increase the risk of a tear in the heart tissue. 
  • A surgical approach that requires incisions in the heart (transseptal approach) if the patient has a baffle or patch between the two upper chambers of the heart (atria) that redirects blood flow (interatrial baffle or patch). An incision made may not close, creating a problem between the atria called an iatrogenic atrial shunt.

In addition, the Sphere-9 Catheter and Affera Ablation System should not be used in heart (coronary) blood vessels that are smaller across than the expanding ablation electrode, as the catheter could damage these vessels.

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