Medtronic Receives FDA Approval for Two Innovative Cardiac Ablation Devices: Affera Mapping and Ablation System and Sphere-9 Catheter

Recently, Medtronic announced that its Affera radiofrequency ablation system and Sphere-9 catheter have received approval from the U.S. Food and Drug Administration (FDA) for market release.

It is reported that this is an integrated electrophysiology product capable of performing pulsed field ablation (PFA) and radiofrequency (RF) ablation, approved for the treatment of persistent atrial fibrillation (AFib) and tricuspid isthmus-dependent atrial flutter. It received CE mark approval in March 2023.

Innovative Products Reflect Differentiated Advantages

The two medical devices approved this time originated from Affera, which Medtronic acquired in August 2022 for $1 billion, bringing in these technologies. The field of electrophysiology is highly competitive, and with these two medical devices, Medtronic further solidifies its position.

Affera Radiofrequency Ablation System is an integrated high-resolution mapping and treatment solution that offers more predictable and flexible procedures, enabling physicians to perform precise mapping and ablation using both radiofrequency and pulsed electric field energy through a single transseptal puncture without the need for catheter exchange. The system includes a mapping/ablation catheter, an energy generator (capable of delivering PFA and RFA), a three-dimensional mapping software (Prism-1), and more.

The Sphere-9 catheter is the first ablation catheter used in conjunction with the Affera system. It is a 7.5Fr bidirectional steerable catheter equipped with an expandable conductive lattice electrode. The catheter is inserted into the sheath in a folded form, but once inside the heart, the lattice expands into a spherical structure with a diameter of 9mm. The lattice contains nine microelectrodes/temperature sensors (0.7 mm in diameter) evenly distributed across its surface.

Unlike traditional radiofrequency ablation catheters, the effective ablation area of the Sphere-9 catheter is 10 times that of a traditional radiofrequency ablation catheter, completing an ablation in 4-5 seconds. Its radiofrequency ablation lesion width exceeds 19mm, and its electropulse ablation lesion width exceeds 17mm.

Moreover, the Sphere-9 catheter, when combined with Prism-1 software, allows for six degrees of freedom position tracking through the use of multiple position sensors at the tip. This is used to track and build three-dimensional maps of the chamber, enabling convenient remapping and effortless transition between ablation and mapping without the need to switch catheters.

The Sphere-9 catheter combines mapping, navigation, and therapeutic functions, and is currently the only catheter capable of delivering both radiofrequency and electropulse energy for ablation, allowing physicians to customize treatment according to patient needs during the ablation process.

In addition to the two blockbuster products mentioned above, Medtronic will also launch Sphere-360, a powerful tool for single-shot pulmonary vein ablation, further enhancing its product portfolio. Sphere-360 perfectly complements Sphere-9, offering both point and surface ablation capabilities. It can also address atrial tachycardia (non-AF) and ventricular tachycardia, providing patients with comprehensive solutions.

The First Company with Two PFA Technologies for Treating Atrial Fibrillation

Notably, the Affera radiofrequency ablation system not only provides Medtronic with its own mapping system but also makes Medtronic the first company to offer two FDA-approved PFA systems for treating AFib. The company's PulseSelect PFA system received FDA approval in December 2023.

The Medtronic PulseSelect PFA System is a new technology that uses pulsed electric fields to treat atrial fibrillation (AF), delivering bipolar, biphasic pulsed electric fields through a circular multi-electrode array catheter.

The PulseSelect system consists of five parts: a steerable multi-electrode circular ablation catheter, PFA main unit, ECG-Gated, Tableside control, and a 10Fr bidirectional sheath. Moreover, the steerable multi-electrode circular ablation catheter of PulseSelect adopts a proprietary biphasic waveform, a unique built-in guidewire, and a 20° forward tilt design, supporting the maneuverability, reliability, and safety of the procedure.

According to Medtronic, the average total energy delivery time for a single pulmonary vein isolation is 30 seconds to isolate all veins. The isolation time and capability have been validated in the large-scale PULSED AF clinical trial.

PulseSelect Utilizes Pulsed Electric Field Ablation to Create Lesions and Scar Tissue, Disrupting Irregular Electrical Pathways and Atrial Fibrillation Triggers in the Heart. However, Unlike Traditional Ablation Methods Such as Radiofrequency Ablation or Cryoablation, PulseSelect Employs a Non-Thermal Ablation Approach That Specifically Targets Cardiac Tissue, Selectively Focusing on Myocardial Cells (Cardiomyocytes) While Avoiding Unnecessary Damage to Surrounding Tissues, Thereby Reducing Complications Commonly Associated with Conventional Ablation Techniques.

In addition, Medtronic's PulseSelect pulsed field ablation system has several product advantages:

Wide Range of Indications: The PulseSelect Pulsed Field Ablation System is currently the only product that can treat both paroxysmal and persistent atrial fibrillation.

Plug and Play: The PulseSelec Pulsed Field Ablation System is a plug-and-play system that can be used with any mapping system, and can even be directly paired with X-ray fluoroscopy imaging.

Built-in Safety Features: Equipped with phrenic nerve test pulses, the voltage of these test pulses is very low. Before starting the formal ablation, this test voltage can be used to assess whether the ablation catheter is close to the phrenic nerve.

Nine Electrodes with Fixed Spacing: Since the nine electrodes at the catheter head form a disk shape with fixed spacing between each other, the generated electric field is consistent, facilitating continuous ablation. Additionally, these nine electrodes can also be used for pacing and sensing.

Small Catheter Diameter: The ablation catheter has a small diameter of only 9Fr (housed within a 10Fr outer sheath), facilitating easy access to various anatomical structures.

In addition to the aforementioned advantages, the PulseSelect pulsed electric field ablation system is also the first pulsed ablation system to receive FDA approval, securing an early market advantage.

Conclusion

With the approval of the Affera radiofrequency ablation system, Medtronic has further solidified its position in the electrophysiology field and is poised to challenge for the top spot in the industry. Moreover, Medtronic continues to innovate and develop, with ongoing efforts to expand its product lineup in the electrophysiology sector. More groundbreaking products are expected to be launched in the future.

References:
1. "Sphere-9: Medtronic’s Electropulse, Radiofrequency, and Mapping Triple-Function Catheter Receives FDA Approval for Market Launch | Outperforming Competitors Once Again" MedTF
2. "PulseSelect: NMPA Approves the First PFA for Persistent Atrial Fibrillation | From Medtronic" MedTF

Editor: Muyan

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