Medtronic Receives FDA Approval to Initiate Early Feasibility Study of Sphere-9 PFA Catheter for Ventricular Tachycardia Treatment

Oct 15, 2024 16:30 CST Updated 16:30

Medtronic

Medical Device Manufacturer

Medtronic Announces FDA Approval of Its PFA Product ---Sphere-9Conduct an early feasibility study to evaluate the Affera mapping and ablation system using the Sphere-9 catheter for the treatment of persistent ventricular tachycardia (VT).

This study will evaluate the Sphere-9 and Affera systems for patients with ventricular arrhythmias caused by scar formation from prior myocardial infarction (heart attack).Ablation Treatment for Patients with Tachycardia.The primary endpoints include the incidence of device- or procedure-related Serious Adverse Events (SAEs) following the ablation procedure, as well as the ablation.Acute Effectiveness for Target Ventricular Tachycardia. A 6-month follow-up will be conducted post-procedure.

PI Evaluation

"Doctors need better tools to safely and effectively treat ventricular tachycardia. The early feasibility study is a positive step in identifying potential new options. I am pleased to be involved in this research and look forward to getting started."

---Vivek Reddy Mount Sinai Health System

Executive Evaluation

"We look forward to learning more about how the Sphere-9 catheter can become a valuable tool in treating this challenging arrhythmia. The catheter provides physicians with mapping and ablation capabilities, offering a choice between PF or RF, along with a large lattice tip designed to manage the typically large ablation target areas where ventricular tachycardia occurs. Currently, the only approved treatments for ventricular tachycardia involve radiofrequency energy, requiring physicians to use multiple mapping and ablation catheters, often leading to long and inefficient procedures. The PFA technology and innovative Sphere-9 design could have a significant impact on patient care."Response."

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

Atrial fibrillation accounts for only half of the patients with arrhythmia, other arrhythmias also include othersAtrial Tachycardia (Non-AF),Ventricular TachycardiaTachycardia, etc.Ventricular TachycardiaTachycardia is a highly lethal type of arrhythmia, according to guideline estimates.UltraMore than 7 million people suffer from clinical ventricular arrhythmias such as ventricular tachycardia and frequent ventricular premature beats.Ventricular TachycardiaTachycardia is one of the most unmet clinical needs in electrophysiological disorders. Current treatmentThe Best Treatment for Ventricular Tachycardia---Implant HeartImplantable Cardioverter Defibrillator (ICD), butImplant HeartThe treatment effect of Implantable Cardioverter Defibrillator (ICD) is not satisfactory, completelyCannot prevent disease progression or cure the disease, and ICD therapy is expensive and the treatment process is painful.

Traditional thermal ablation technology can only be used as a second-line treatment option, becauseThe ventricular wall is much thicker than the atrial wall.Ventricular tachycardia ablation often requires ablating a larger and deeper ablation area.Traditional Thermal Ablation TechnologyUnable to achieve the required ablation depth, even with thermal ablation treatment, in half of the patients.Patients will relapse within six months after ablation, so it can be said that traditional thermal ablation is very unreliable.

PFA has become the current electrophysiologyA Potential Hope in the Field of Ablation for Treating Ventricular Tachycardia. Therefore, Some Innovative Medical Device Companies Have Begun to Apply Electropulse TechnologyVentricular TachycardiaOver-speed Treatment,Including Field Medical, a new company founded by Steven Mickelsen, the father of PFA, which is also developing treatments.Ventricular TachycardiaThe excessively rapid PFA ablation product. Medtronic is the first company to apply PFA technology forVentricular TachycardiaThe giant in tachyarrhythmia treatment, this also shows Medtronic's proactive approach in the electrophysiology field (compared to the other three giants).

Therefore, the entire electrophysiology field is highly focused on PFA therapy.Ventricular TachycardiaRapid efficacy. It is hoped that PFA can provide hope for these patients with limited treatment options and save their lives.

Affera

AfferaMainly has a complete electrophysiology treatment solution. This solution includes a mapping/ablation catheter (Sphere-9), an energy generator (capable of delivering PFA and RFA), a three-dimensional mapping system (Prism-1), etc.

The core of this set of solutions isSphere-9, a 7.5Fr bidirectional steerable catheter with an expandable conductive lattice electrode, 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 9 mm.The lattice contains 9 micro-electrodes/temperature sensors (diameter 0.7 mm), evenly distributed on its surface.Prism-1ThroughUsing multiple position sensors at the tip allows for 6 degrees of freedom in position tracking, enabling the tracking and construction of a three-dimensional map of the chamber.

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

Affera Prism-1 compensates for Medtronic's lack of mapping and navigation technology, as other top players already have their own.Mapping Navigation Technology. AndSphere-9 perfectly complements its weak PFA field. To compete with Johnson & Johnson, Boston Scientific, and others, relying solely onPulseSelect is far from enough. Especially since Boston Scientific has already gained the upper hand in PFA and simultaneously possesses more types of PFA ablation catheters; without uniquely superior technology, it will be difficult to surpass Boston Scientific.

AfferaIn addition to ablation catheters, they are also developing pulmonary vein PFA products---SpherePVI, and completed the first clinical study in July of last year.SpherePVI Is a new type of 8F online multi-segment grid spherical catheter designed to effectively provide pulmonary vein isolation. It canAfferaUsed in combination with other products, becomingSphere-9Product Line Supplement.

Medtronic

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.