Proven Contrast Reduction with Uncompromised Image Quality. The only FDA-indicated technology for contrast volume reduction.

Transcription

1 Proven ontrast Reduction with Uncompromised Image Quality The only FA-indicated technology for contrast volume reduction.

2 linical guidelines to reduce contrastinduced AKI Evidence-based guidelines for coronary angiography in patients at risk for contrast-induced AKI. 1. SREEN. Patients should be assessed for risk of contrast-induced AKI before PI. 2. HYRATE. Patients undergoing cardiac catheterization with contrast media should receive adequate preparatory hydration. 3. MINIMIZE YE. In patients with K (egfr <60mL/ min), the volume of contrast media should be minimized. Thus far, the only strategies clearly shown to reduce the risk of contrast-induced AKI are hydration and minimizing the amount of contrast media. 1 Levine, et al. A/AHA/SAI guidelines JA 2011 Minimize dye. The call to minimize and monitor contrast dye in patients with K and other at-risk factors is well established in the clinical literature. 2 Limit contrast dose as low as clinically possible. Monitor total contrast administered to the patient in real time. Establish contrast dose threshold volumes to help limit risk.

3 ontrast Reduction Real-time Monitoring Uncompromised Imaging The yevert PLUS EZ ontrast Reduction System is a dye management delivery solution for patients with at-risk kidney factors, including chronic kidney disease, diabetes, older age, and heart failure. It reduces contrast volume to the patient and provides real-time dose monitoring throughout the procedure. Quick, easy set-up, and uncompromised image quality makes yevert PLUS EZ the smart way to help mitigate the risk of AKI in the cath lab. Simple one-step prep Module, syringe and monitor connect via luetooth

4 Over 40% Average ontrast Reduction A randomized controlled trial showed significant contrast reduction with uncompromising imaging in comparison to the control group. 3 This result was further supported in a US multi-center study that confirmed over 40% average contrast reduction. 4 OVER 40% AVERAGE REUTION IN ONTRAST OSAGE TO THE PATIENT yevert Randomized ontrolled Trial (N=94) % ontrast Injected to Patient ontrol Group 41% Volume Reduction yevert Group esch, S. et al., Impact of a novel contrast reduction system on contrast savings in coronary angiography The yevert randomised controlled trial, Int J ardiol (2018), Uncompromised Imaging Injections into coronary arteries may result in excess reflux into the aorta that is not needed for imaging. yevert reduces contrast amount without compromising image quality, as seen by minimization of excess reflux. With ontrast Reduction Without ontrast Reduction Reduced contrast refl ux leads to decreased volume usage ontrast refl ux leads to increased unnecessary volume usage Reduced ontrast ecreases AKI Risk Patients with pre-existing chronic kidney disease are at high risk of contrast-induced acute kidney injury (AKI), also known as contrast-induced nephropathy (IN). Expected reduction in AKI (%) 25% 20% 15% 10% 5% MOEL PREITE REUTION IN TOTAL AKI ASES Y PERENT REUTION IN ONTRAST VOLUME* = ontrast sparing intervention used in all patients 13-18% Reduction in AKI 30-45% ontrast Reduction Reduction in ontrast Volume (%) * Adapted from Gurm et al.journal of Invasive ardiology. April 2016, Vol 28, no 4; page

5 Establish ontrast Threshold Volume Monitor contrast volume to a prespecified threshold based on patient kidney function. linical study publications reinforce the value of setting thresholds to reduce AKI. Published ontrast Threshold Volumes 5 First Author, Year (Ref. #) Study Population and Procedure ontrast Volume Threshold Algorithm ased on Kidney Function Gurm et al., ,957 PI < 2.0 contrast vol/egfr ratio Laskey et al., ,179 PI < 3.7 contrast vol/egfr ratio rown et al., ,065 PI < 5 ml x body wgt/sr egfr = estimated Glomerular Filtration Rate; PI = Percutaneous oronary Intervention; Sr = Serum reatinine; vol = volume; wgt = weight. Real-Time ose Monitoring Automatically keep track of the amount of contrast delivered to patient during procedure. A umulative contrast volume Volume per injection Triple toggle button Percent saved on last injection Average percent saved over case Percent of contrast in syringe Amount remaining until threshold reached E ontrast threshold volume A E Accurate Volume Recording Supports PI performance measures issued by the cardiology professional societies to improve quality of care. A Total contrast volume delivered Percent to threshold achieved ontrast volume saved ontrast percent saved A

6 Simple, one-step prep Interfaces with standard manifold systems Easy-to-use and incorporate into workflow iverts contrast on each injection, including puffs Proprietary Pressure ompensating Valve system automatically self adjusts for different catheter configurations, contrast types and injection rates isposable, STERILE (Single-Use) components Re-usable, provided NON-STERILE Model No. escription Used With UOM Qty Model No escription HV-EZ-RRS-10 yevert PLUS EZ isposable Kit ontents: Module with Smart-Syringe (Ring Plunger-Ring grip, Swivel Luer) High-Viscosity agents: Visipaque 320 (Iodixonal 320 mgl/ml) Omnipaque 350 (Iohexol 350 mgl/ml) Isovue 370 (Iopamidol 370 mgl/ml) OX 10 MW-US Wireless isplay LV-EZ-RRS-10 yevert PLUS EZ isposable Kit ontents: Module with Smart-Syringe (Ring Plunger-Ring grip, Swivel Luer) Low-Viscosity agents: Visipaque 270 (Iodixonal 270 mgl/ml) Omnipaque 300 (Iohexol 300 mgl/ml) OX 10 R-RRS Smart-Syringe EA 1 References 1. Levine GN et al., AF/AHA/SAI Guideline for Percutaneous oronary Intervention. A Report of the American ollege of ardiology Foundation/ American Heart Association Task Force on Practice Guidelines and the Society for ardiovascular Angiography and Interventions. irculation, 2011; 124:e574-e Naidu, Srihari et al., SAI Expert onsensus Statement: 2016 est Practices in the ardiac atheterization Laboratory. atheterization and ardiovascular Interventions, 88: , esch, S. et al., Impact of a novel contrast reduction system on contrast savings in coronary angiography The yevert randomised controlled trial, Int J ardiol (2018), 4. Gurm H, ertolet, Kereiakes, Mavromatis K, Rao S, Shah A, et al., A Multi-enter Observational Study of yevert Plus ontrast Reduction System [abstract]. Proceedings of the Society for ardiovascular Angiography and Interventions 41st Annual Scientifi c Sessions. atheterization and ardiovascular Interventions. 2018;91(S2):S16. est of the est Poster Presentation Abstract no V Mavromatis K., Editorial omment: The Imperative of Reducing ontrast ose in Percutaneous oronary Intervention. JA ardiovasc Interv 2014;7: Gurm HS, ixon SR, Smith E et al., for the M2 Registry. Renal function-based contrast dosing to defi ne safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am oll ardiol 2011;58: Laskey WK, Jenkins, Selzer F, et al., for the NHLI ynamic Registry Investigators. Volume-to-creatinine clearance ratio: a pharmacokinetically based risk factor for prediction of early creatinine increase after percutaneous coronary intervention. J Am oll ardiol 2007;50: rown JR, Robb JF, lock A et al., oes safe dosing of iodinated contrast prevent contrast-induced acute kidney injury? irc ardiovasc Interv 2010;3: Osprey Medical 5600 Rowland Road, Suite 250 Minnetonka, MN USA Phone: Fax: ustomer Service Toll-Free Phone: Fax: customerservice@ospreymed.com E REP MedPass International Limited, Windsor House, retforton, Evesham, Worcestershire, WR11 7JJ, Vereinigtes Konigreich yevert, Osprey Medical, and e Kind to Kidneys are trademarks of Osprey Medical, Inc. in the US and other countries Osprey Medical, Inc. All Rights Reserved. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. Risks may include air emboli and infection. AUTION: Federal (USA) lay restricts these devices to sale by or on the order of a physician PRO146A