Sphere-9: A New Hope for Ventricular Tachycardia Patients | Medtronic Enrolls First Patient in Early Feasibility Study

Medtronic Announces Its Dual-Energy CatheterSphere-9AndCompleted the First Patient Clinical Enrollment with Affera 3D Mapping System (A TreatmentEarly Feasibility Study of Sustained Ventricular Tachycardia (VT)Evaluation of the use of Sphere-9 and Affera's novel radiofrequency and pulsed field ablation waveforms for the treatment of patients with ventricular tachycardia due to prior myocardial infarction scars.

PI Evaluation

"Despite significant advances in cardiac ablation technology over the past few years, there remains a substantial unmet clinical need for novel and effective treatments for VT. With the first patient now treated in this study, we have taken an important step forward for this underserved patient population."

---Vivek Reddy  Mount Sinai Health Syste

Executive Evaluation

"Committed to our mission, we continue to explore new ways to improve care for patients with arrhythmias. Sphere-9, with its unique advantages—including the ability to perform mapping and ablation using either radiofrequency or pulsed field energy via a single catheter—is an exceptional tool for treating atrial arrhythmias. Clinicians need better tools to treat VT, and this early feasibility study demonstrates our commitment to advancing clinical evidence in this field. This is an important step in evaluating the impact of Sphere-9 on VT treatment outcomes."

---Khaldoun Tarakji  Vice President and Chief Medical Officer of the Cardiac Ablation Solutions Division, part of Medtronic's Cardiovascular Business Portfolio

Sphere-9It is an ablation catheter that is highly anticipated in the market. According to a survey by Citibank earlier this year, Medtronic is expected to capture 56% of the PFA market next year. Last year, newly approvedSphere-9&Affera Becomes the Key to Medtronic's Success in China, Directly Contributing to Medtronic45% market share. It can be said that in the field of atrial fibrillation treatment, Medtronic solely relies onSphere-9can defeat Boston Scientific and Johnson & Johnson.

Of course, currentlySphere-9Can only be applied to treat patients with atrial fibrillation, and for an equally largeVentricular TachycardiaPatients are powerless because of the lack of strong evidence to prove.Sphere-9Efficacy and safety. ThereforeMedtronic Launches This Study Hoping to Break Through Traditional Ablation TherapyLocalized Ventricular Tachycardia (Traditional thermal ablation treatment for VT is basically ineffective). ForFor patients with ventricular tachycardiaSphere-9Is expected to address their long-standing unmet clinical needs.

OnceSphere-9Proven to effectively treat VT patients, further widening the gap with competitors.

Sphere-9

Sphere-9It is an ablation catheter with an integrated design, which achieves the entire process of mapping, ablation, and efficacy verification through a single transseptal puncture without the need for catheter exchange.

• 9mm Compressible Mesh Ablation Electrode: Optimize Energy Distribution
• 9 Integrated Thermocouple Microelectrodes: Enabling Precise Temperature Monitoring
• Central Reference Electrode: Enhanced Electrical Signal Stability
• Low-Flow Central Perfusion System: Reducing the Risk of Fluid Overload
• 8 Fr Bidirectional Bending Catheter Shaft: Enhanced Maneuverability