“We expect the completion for our U.S. VARIPULSE study to occur in the fourth quarter.”

In context

“re plaque psoriasis expected to begin in November. Moving to MedTech, notable highlights in the quarter include significant advancements in electrophysiology across our cardiac ablation platform. We received FDA clearance from multiple atrial fibrillation ablation products in our portfolio to be used in a workflow without fluoroscopy. This FDA indication is unique to Johnson & Johnson and is a significant advancement where caregivers and patients are not exposed to harmful fluoroscopy-related radiation during their cardiac ablation procedures. It also allows for the removal of heavy lead protective equipment that may lead to orthopedic complications for care teams. In pulse field ablation, we have completed our clinical trial in Europe and submitted for CE mark for our VARIPULSE Catheter. We expect the completion for our U.S. VARIPULSE study to occur in the fourth quarter. We are also simultaneously advancing clinical studies for two additional pulse field ablation catheters, the STSF dual energy catheter, capable of delivering both PF and RF energy through the same device, and Omnipulse, a large tip focal catheter. Beyond electrophysiology, we have completed enrollment in the Abiomed Impella ECP clinical study, a landmark pivotal trial designed to demonstrate the safety and efficacy of the Impella ECP during high-risk PCI procedures. Impella ECP is the world's smallest heart pump and the only heart pump compatible with small bore access and closure techniques. While not a clinical advancement, we have also taken steps in the quarter to improve MedTech's future margin profile, implementing a restructuring program designed to simplify and focus the operation”