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FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure angiography and/or interventional procedures. The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires.

The FFR v2.5 software is used to obtain pressure measurements and is installed on the Volcano s5/CORE Systems. These systems are a multi-modality platform that provides Intravascular Ultrasound (IVUS) Imaging, Fractional Flow Reserve (FFR) pressure measurements, and Instant Wave-Free Ratio (iFR) pressure measurements. Pressure measurements are obtained through the use of pressure guide wires. Real-time image visualization of patient anatomy during procedures. FFR pressure measurements are obtained during fluoroscopic procedures after the administration of a hyperemic agent such as adenosine. iFR pressure measurements do not require the use of a hyperemic agent. The FFR Modality is calculated based on the entire cardiac wave cycle, whereas the iFR® Modality is calculated by isolation of the cardiac wave cycle where intracoronary resistance is naturally constant and minimized and where intracoronary flow is maximized. This results in the ability to measure pressure without administration of a hyperemic agent with the iFR® Modality whereas the FFR Modality pressure reading is calculated after administration of a hyperemic agent. Modifications to the software include the ability to take FFR and iFR measurements without relying on ECG and allowing for broadcast FFR and iFR measurement data to a third party system over a network.

The Pioneer Plus catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus catheter also provides an intraluminal cross-sectional ultrasound image of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total occlusions) prior to additional intervention (i.e. PTA, stent, etc.). The Pioneer Plus catheter is not indicated for use in the coronary or cerebral vasculature.

The Pioneer Plus catheter is a dual lumen catheter that is inserted through a commercially available 6F introducer sheath and placed percutaneously into a peripheral vessel. The Pioneer Plus catheter tracks to its intended site in the vasculature over a standard, commercially available 0.014" (0.36 mm) tracking guidewire. The Pioneer Plus catheter utilizes an extendable, hollow Nitinol needle - minimum internal needle diameter: 0.016" (0.43 mm): it is compatible with floppy 0.014" (0.36 mm) over the wire (OTW) guidewires to facilitate the redirection and placement of the guidewire into peripheral vessels. The needle orientation placement is achieved through the use of an intravascular ultrasound (IVUS) transducer mounted at the distal end of the Pioneer Plus catheter. The Pioneer Plus catheter operator navigates the peripheral vasculature under fluoroscopic guidance and uses IVUS imaging to direct the needle to achieve optimal placement. The operator uses the Needle Deployment Ring incorporated into the handle of the Pioneer Plus catheter to extend the needle from the catheter. The needle can be extended up to 7mm in length, or to a pre-determined distance using the Stop Ring. A 0.014" (0.36 mm) OTW guidewire (needle guidewire) can then be advanced through the needle and used to facilitate the placement of subsequent catheters once the Pioneer Plus device is withdrawn.