Medtronic announced itsSphere-9The Affera Mapping and Ablation System and ablation catheter have received FDA approval for market release. This multifunctional, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter is designed to treat persistent atrial fibrillation and tricuspid isthmus-dependent atrial flutter.
"The importance of this innovative technology should be emphasized; Affera is a game-changer in the treatment of atrial fibrillation and atrial flutter. The Affera system provides physicians with a safe, effective, and efficient solution to address this common and increasingly serious heart condition, necessitating optimized solutions for patients. Experienced physicians face a short learning curve, and the possibilities for treating atrial fibrillation are limitless."---Vivek Reddy Mount Sinai Health System"The Affera system is designed to address the surgical challenges faced by the electrophysiology community while maintaining high standards of safety and efficacy for patients. By enabling a single transseptal, zero fluoroscopy, and zero exchange workflow, the Sphere-9 catheter uniquely integrates mapping and ablation technologies, offering the flexibility of using either pulsed field or radiofrequency energy. This marks an exciting milestone in the field, with Medtronic's robust innovation pipeline driving continuous advancement."---Doron Harlev, Vice President of Engineering for Medtronic's Cardiac Ablation Solutions and Founder of Affera"At Medtronic, we have a 75-year tradition of bringing disruptive innovations to market, guided by our mission and commitment to address unmet patient needs. With Affera’s approval, we are excited to bring clinicians a new mapping and ablation solution designed to make atrial fibrillation treatment safer, more effective, and more efficient. The potential of Affera is limitless. We will continue to honor our commitment to innovation, including new indications, to advance cardiovascular care and improve patient outcomes."---Rebecca Seidel, President of Cardiac Ablation Solutions Business in Medtronic's Cardiovascular Portfolio
The field of electrophysiology has become a battleground for all players. Whether it's the four giants—Boston Scientific, Medtronic, Johnson & Johnson, and Abbott—or countless startups, everyone is striving to secure a place in the electrophysiology market through innovation. Overseas, Boston Scientific and Medtronic are in the top tier, followed by Johnson & Johnson, with Abbott trailing behind. The rest are either future acquisition targets of the four giants or obscure participants. In the U.S. market, a fierce competition between Boston Scientific and Medtronic has already taken shape, with the two powers jointly capturing 20% of the U.S. electrophysiology ablation market. This has led to the gradual retreat of thermal ablation. This month, as Medtronic and Boston Scientific once again launched their respective innovative PFA technologies, the exit of thermal ablation technology in the fourth quarter has accelerated. The market expects that by the end of next year, PFA will account for more than 50% of the U.S. market. Time is running out for thermal ablation technology, and similarly, there isn't much time left for overseas PFA participants either.
This timeSphere-9Ablation catheters and the Affera mapping and ablation system have been approved, addressing Medtronic's biggest pain point — the lack of its own mapping system. With its own mapping system, Medtronic is fully capable of competing with the other three major players and has the potential to seize the top position in the electrophysiology field. The futureMedtronic will alsoLaunch Sphere-360, a powerful tool for single-shot pulmonary vein ablation, further enhancing Medtronic's product line andSphere-9Forming a perfect complement, capable of both point ablation and surface ablation, and also able to address atrial tachycardia (non-AF), ventricular tachycardia, etc., providing patients with a comprehensive solution.
AfferaIt is an integrated high-resolution mapping and treatment solution that provides more predictable and flexible procedures, enabling physicians...The system enables accurate mapping and ablation using both radiofrequency and pulsed electric field energy through a single transseptal puncture without the need for catheter exchange. The solution includes a mapping/ablation catheter, an energy generator (capable of delivering PFA and RFA), a 3D mapping software (Prism-1), and more.Sphere-9Is the first ablation catheter used in conjunction with the Affera system, itsIt is a 7.5Fr bidirectional steerable catheter 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 9 micro-electrodes/temperature sensors (diameter 0.7 mm), evenly distributed across its surface.Its effective ablation area is 10 times that of a traditional radiofrequency ablation catheter, completing an ablation in 4-5 seconds, with the lesion width from radiofrequency ablation exceeding 19mm and the lesion width from electropulse ablation exceeding 17mm.Sphere-9By integrating with Prism-1 software, multiple position sensors can be used at the tip to allow six degrees of freedom for position tracking and constructing a three-dimensional map of the chamber.Conveniently remap, effortlessly switch from ablation to mapping without changing catheters.Sphere-9Combining mapping, navigation, and treatment functions, it 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.
The IDE clinical study data of Sphere-9 (control group using THERMOCOOL SMARTTOUCH SF with the CARTO mapping system) shows:
The incidence of major safety events was 1.4%, compared to 1% in the control group.
Main Efficiency 74%
80% effectiveness rate > 10 cases
Each surgery saves more than 25 minutes.
Medtronic is one of the largest medical technology, services, and solutions companies in the world, alleviating pain, restoring health, and extending life for millions of people globally. With over 90,000 employees worldwide, Medtronic serves doctors, hospitals, and patients in more than 150 countries. The company is committed to collaborating with stakeholders around the world to advance healthcare.
