The Hotwire Transseptal Access System includes the Hotwire RF Generator and Hotwire RF Guidewire, giving electrophysiologists the tools they need for left-heart access.
All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell.