Medtronic recently announced that the first patient has been enrolled in a US Food and Drug Administration (FDA) early feasibility study evaluating the Affera mapping and ablation system with the Sphere-9 catheter using new investigational radiofrequency (RF) and pulsed field (PF) waveforms in the treatment of sustained ventricular tachycardia (VT).
“Despite significant advances in cardiac ablation over the last several years, a significant unmet need remains for new and effective treatment options for VT,” said Vivek Reddy (Mount Sinai Health System, New York City, USA). “With the first patient treated in this study, we’ve taken an important step forward for patients in this underserved patient population.”
The study will evaluate new investigational RF and PF waveforms for ablation treatment using Sphere-9 and the Affera system for patients who suffer from VT due to scarring from a prior myocardial infarction, according to Medtronic.
A recent press release from the company details that the Affera mapping and ablation system with the Sphere-9 catheter is an all-in-one, dual-energy (RF plus PF) ablation and high-density mapping catheter for use in cardiac ablation procedures. While cardiac ablation is an established treatment for VT, outcomes have “remained suboptimal”, with “little innovation” in recent years, the release posits, adding that a significant unmet need exists with regard to improving patient care.
“Aligned to our mission, we are continually seeking new ways to improve care for arrhythmia patients. Sphere-9 is an excellent tool for atrial arrhythmias given its unique features, including a single catheter to map and ablate using radiofrequency or pulsed field energy,” said Khaldoun Tarakji, vice president and chief medical officer of the Cardiac Ablation Solutions business—which is part of the Cardiovascular Portfolio—at Medtronic. “Physicians need better tools to treat VT, and this early feasibility study demonstrates our commitment to advancing the clinical evidence in the field. It’s a major step toward evaluating the impact of Sphere-9 on VT outcomes.”
In March, Medtronic also announced that its Affera mapping and ablation system—including the Sphere-9 catheter and the Affera Prism-1 mapping software—is now in clinical use in Sweden for the first time, with additional Nordic countries to follow “soon”.
