Philips Launches FDA-Cleared IntraSight Plus, Promising 47% Workflow Savings
Royal Philips introduced IntraSight Plus, an interventional cardiology platform that integrates Class IA IVUS and iFR/FFR on a single console with FDA 510(k) clearance and CE marking. The system offers 47% workflow time savings and streamlined data handling via Philips’ Azurion integration, potentially boosting cath lab efficiency and equipment sales.
1. Product Launch and Regulatory Clearances
Royal Philips unveiled IntraSight Plus, its next-generation interventional cardiology platform combining Class IA IVUS, instantaneous wave-free ratio and fractional flow reserve on a single interface. The system has secured FDA 510(k) clearance in the USA and CE marking in Europe for clinical use.
2. Workflow Efficiency and Integration
IntraSight Plus streamlines minimally invasive coronary procedures by merging intravascular imaging, physiological assessment and procedural planning, claiming up to 47% system operation time savings. Seamless connectivity with the Azurion DataHandler reduces duplicate data entry and centralizes control at the bedside.
3. First Clinical Application
Prof. Dr. Jan-Malte Sinning completed the first revascularization case using IntraSight Plus at a Cologne hospital, addressing a complex three-vessel STEMI patient. The integrated tri-registration of angiography, physiology and imaging enabled precise lesion targeting and optimized stent deployment prior to patient discharge.
4. Commercial Outlook and Market Impact
Commercial availability of IntraSight Plus is pending market release and regulatory requirements, positioning Philips to deepen its presence in cath labs worldwide. Enhanced efficiency and unified guidance may drive increased adoption of Philips’ image-guided therapy portfolio and support future revenue growth.