ILLUMENATE pivotal trial of Stellarex confirms safety profile in peripheral arterial disease.- Royal Philips
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The Janssen Pharmaceutical Companies of Johnson & Johnson presented new data from the Phase III VOYAGER PAD study which showed Xarelto (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event.
Royal Philips announced the five-year patient-level meta-analysis of two major randomized controlled trials (RCTs). The findings, which represent the highest level of the evidence pyramid ,confirm the long-term safety of the Philips Stellarex Drug-Coated Balloon (DCB).
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the FDA for a new indication to expand the use of Xarelto (rivaroxaban) in patients with peripheral artery disease (PAD).