Pulsed field ablation dominated the news out of the Heart Rhythm Society meeting this week with three late-breaking studies highlighting the safety and efficacy of the technology replacing thermal ablation for treatment of atrial fibrillation and active discussion of the ‘unprecedented’ growth of these procedures. Boston Scientific Corp’s Farapulse is rapidly building dominance in the field, while results from Johnson & Johnson’s Varipulse study and Medtronic plc’s trial of the Affera system set up those companies for U.S. FDA approval later this year.
Medtronic plc said its investigational Omniasecure defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals, in the global Lead Evaluation for Defibrillation and Reliability (LEADR) pivotal trial.
Data from Meril Life Sciences Pvt Ltd.’s Landmark trial showed that its series of Myval transcatheter heart valves were non-inferior compared with Edwards Lifesciences Corp.’s Sapien BEV and Medtronic plc’s Evolut SEV devices, with regards to safety and effectiveness in patients undergoing transcatheter aortic valve implantation.
Elixir Medical Corp. revealed that data from the Pinnacle I study has validated the safety and effectiveness of its Lithix Hertz contact intravascular lithotripsy system to treat moderate to severe calcified coronary artery lesions by percutaneous transluminal coronary angioplasty.
Stereotaxis Inc. said it is buying electrophysiology catheter maker Access Point Technologies EP Inc. to enhance its minimally invasive endovascular surgical robotics technology offerings.
There should be no more excuses to the adoption of renal denervation (RDN) as a treatment for hypertension given the recent approval by the U.S. FDA of two technologies and a range of guidelines recommending the therapy, delegates heard at the EuroPCR conference in Paris. In a discussion on the technology, panelists argued that on the back of solid evidence, RDN should be offered as a treatment given that the therapy is a safe method to reduce high blood pressure.
Two-year data from Elixir Medical Corp.’s Bioadaptor randomized controlled trial showed that there is a significant clinical advantage in using its Dynamx coronary drug-eluting bioadaptor system over Medtronic plc’s Resolute Onyx drug-eluting stent in patients with coronary artery disease.
Data from the transcatheter valve and vessel trial showed that percutaneous interventions in patients with aortic stenosis and coronary disease resulted in significantly lower mortality rates than those receiving surgical treatment.
One-year results of the DETOUR2 trial published in the Journal of Vascular Surgery demonstrate outstanding results for Endologix LLC’s percutaneous transmural arterial bypass system for treatment of severe peripheral artery disease. The study showed nearly all patients experienced improvement in acute limb ischemia with freedom from occlusion of 92% and freedom from revascularization of nearly 88% at 12 months.
Field Medical Inc. kicked off its first-in-human study for its Fieldforce ablation system, designed for use in ventricular arrhythmias. The Ventricular Catheter Ablation Study study will enroll 60 patients in five centers around the world, most recently kicking off in the Na Homolce Hospital in Prague, Czech Republic.