Recently, Medtronic announced that its Affera radiofrequency ablation system and Sphere-9 catheter have been approved for market by the US Food and Drug Administration (FDA).

It is understood that this is an integrated electrophysiological product capable of pulsed field ablation (PFA) and radiofrequency (RF) ablation, approved for the treatment of persistent atrial fibrillation (AFib) and tricuspid isthmus dependent atrial flutter, and previously obtained CE marking approval in March 2023.

Innovative products demonstrate differentiation advantages
The two medical devices approved this time originated from Affera, which Medtronic acquired for $1 billion in August 2022 and introduced these technologies. The competition in the field of electrophysiology is fierce, and Medtronic has further solidified its position with these two medical devices.

The Affera radiofrequency ablation system is an integrated high-resolution mapping and treatment solution that provides more predictable and flexible surgery, allowing doctors to accurately map and ablate using radiofrequency and electrical pulse energy through a single atrial septal puncture without the need for catheter replacement. The plan includes a mapping/ablation catheter, an energy generator (capable of releasing PFA and RFA), a 3D mapping software (Prism-1), and so on.

The Sphere-9 catheter is the first ablation catheter to be used in conjunction with the Affera system. It is a 7.5Fr bidirectional adjustable bend catheter with an expandable conductive lattice electrode. The catheter is inserted into the sheath in a folded form, but once it enters the heart, the lattice expands into a spherical structure with a diameter of 9mm. The lattice contains 9 micro electrodes/temperature sensors (diameter 0.7 mm) evenly distributed on its surface.

Unlike traditional radiofrequency ablation catheters, the Sphere-9 catheter has an effective ablation area 10 times that of traditional radiofrequency ablation catheters, and can complete ablation in 4-5 seconds. Its radiofrequency ablation lesion width exceeds 19mm, and the electric pulse ablation lesion width exceeds 17mm.

Moreover, the Sphere-9 catheter, combined with Prism-1 software, allows for 6-degree-of-freedom positioning by using multiple position sensors at the tip for tracking and constructing a 3D map of the chamber. Convenient remapping, effortlessly transitioning from ablation to mapping without switching catheters.

The Sphere-9 catheter combines mapping, navigation, and treatment functions and is currently the only catheter capable of delivering radiofrequency and electrical pulse capabilities for ablation, allowing doctors to provide the ability to customize treatment according to patient needs during the ablation process.

In addition to the two heavyweight products mentioned above, Medtronic will also launch the Sphere-360, a single ablation tool suitable for pulmonary veins, in the future, making Medtronic's product line more complete and perfectly complementary to Sphere-9. It can perform both point and surface ablation, and can also solve atrial tachycardia (non atrial fibrillation), ventricular tachycardia, etc., providing patients with targeted solutions.

The first enterprise to have two PFA technologies for treating atrial fibrillation
It is worth noting that the Affera radiofrequency ablation system not only gives Medtronic its own mapping system, but also makes Medtronic the first company to offer two FDA approved PFA systems for the treatment of AFib. The company's PulseSelect PFA system received FDA approval in December 2023.

The Medtronic Pulse Select PFA system is a new technology for treating atrial fibrillation (AF) using pulsed electric fields, which can provide bipolar and biphasic pulsed electric fields through a circular multi electrode array catheter.

The PulseSelect system consists of five parts: a controllable multi electrode annular ablation catheter, PFA host, ECG Gated, Tableside control, and 10Fr bidirectional sheath. Moreover, PulseSelect's controllable multi electrode annular ablation catheter features a proprietary biphasic waveform, unique built-in guide wire, and a 20 ° forward tilt design, which supports surgical operability, reliability, and safety.

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 ability have been confirmed in large-scale clinical trials of PULSED AF.

Pulse Select uses pulsed electric fields to ablate or create damaged and scar tissue, interrupting irregular electrical pathways in the heart and triggering factors for atrial fibrillation. However, unlike traditional ablation methods such as radiofrequency ablation or cryoablation, PulseSelect uses non thermal ablation methods that prioritize targeting cardiac tissue and selectively target myocardial cells (cardiomyocytes) to avoid unnecessary damage to surrounding tissues and avoid complications caused by traditional ablation methods.

In addition, Medtronic's PulseSelect pulsed electric field ablation system also has multiple product advantages:
 Widely applicable: PulseSelect pulsed electric field ablation system is currently the only product that can treat both paroxysmal and persistent atrial fibrillation;
 Plug and play: PulseSelec pulsed electric field ablation system is a plug and play system that can be used with any mapping system, and even directly with X-ray fluoroscopy imaging;
 Built in safety function: Equipped with a diaphragm nerve test pulse, the voltage of the diaphragm nerve test pulse is very low. This test voltage can be used to evaluate whether the ablation catheter is close to the diaphragm nerve before starting the formal ablation process;
 Nine electrodes with fixed spacing: Due to the circular shape of the nine electrodes at the head of the catheter, the spacing between them is fixed, resulting in a consistent electric field for continuous ablation. In addition, these nine electrodes can also be used for pacing and sensing;
 Small catheter diameter: The ablation catheter has a small diameter of only 9Fr (with an outer sheath of 10Fr diameter), which facilitates easy entry of the catheter into various anatomical structures.

In addition to the above advantages, PulseSelect pulsed electric field ablation system is also the first FDA approved pulsed ablation system, seizing the market ahead of time.

Source: https://news.yaozh.com/archive/44439.html