Press Releases

If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage

New data for investigational nipocalimab in Sjögren’s Disease (SjD) and new research on the impact of TREMFYA® (guselkumab) in psoriatic arthritis (PsA) will be highlighted across three oral sessions and a plenary session Results from the Phase 2 DAHLIAS study of nipocalimab in SjD show nipocalimab met the primary endpoint with a reduction in ClinESSDAI score from baseline and other key efficacy endpoints at Week 24 compared with placebo, presented in a plenary session Results from the PsABIOnd observational study highlight the patient-reported impact in psoriatic arthritis (PsA) disease burden following treatment with TREMFYA®, presented as an oral presentation

Highlights include the debut of the Solutions in Motion™ initiative aimed at bringing together advanced surgical techniques, innovative implants, and data-driven enabling technologies

The VARIPULSE™ Platform is the first and only Pulsed Field Ablation (PFA) System in the U.S. fully integrated with the CARTO™ 3 Electro-anatomical Mapping System, driving efficiency, reproducibility and accuracy1 Approval is supported by the admIRE study, where 85% peak primary effectiveness 12-month success and minimal-to-no fluoroscopy were achieved2,i

DISRUPT BTK II, a global post-market study, finds favorable 30-day outcomes for peripheral IVL in the most challenging calcified lesions, including patients with CLTI

Novel Intravascular Lithotripsy (IVL) catheter demonstrates ability to modify calcium safely, enabling treatment and crossing of tightly-stenosed lower limb lesions Technology has received U.S. FDA clearance for patients with peripheral arterial disease

The OMNY-AF trial evaluates safety and efficacy of the investigational OMNYPULSE™ Platform, a novel catheter that combines a large ablation area with mapping capabilities

The first prospective female-only study of coronary interventions in complex calcific disease, EMPOWER CAD aims to confirm benefits of Shockwave intravascular lithotripsy in women Co-Principal Investigator Margaret McEntegart, MD, completed enrollment during a live case at this year’s Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington D.C.

Approval provides a new treatment option for some of the youngest people living with HIV-1 in the European Union