2PCI Unmet Clinical Needs For SVGDistal embolisationNo reflowHigh rate of restenosisFor AMI / other thrombus loaded lesionsPatients with DESLate ST due to incomplete endothelializationBleeding complications due to long term Plavix use
3The Evolution of Stents Bare MetalDrug Eluting1stGeneration2ndMGuard3rdWhile addressing the restenosis problem,today's stent technology overlooksthe adverse effects of acute embolization
4About MGuard’s Technology Micron Circular Knitting TechnologyNet Material: Poly Ethylene Terephthalate (PET)Fiber diameter: 20 μmAperture size at expanded state: ~180μm X 200μmSystem profile - 1.3mmNet secured to the distal and proximal end of the stent
5About MGuard’s Technology The stent is wrapped with the ultra-thin polymer meshed netThe net is designed for maximal flexibility without compromising the strength of the fiberThe net expands seamlessly when the stent is deployed
6About MGuard’s Clinical Benefits MGuard is designed toTrap thrombotic material to protect bloodstream from embolic debrisReduce vessel injury and restenosis rateMaintain standard procedureInjury lowered by MGuard
7About MGuard’s Clinical Benefits MGuard Lifelong Embolic ProtectionMGuard blocks embolic showers and plaque detachment from the arterial wall, blocking debris at the source during and post procedure.MGuard addresses the risk of suboptimal perfusion and no-reflow in occluded lesions.
8About MGuard’s Clinical Benefits Lower arterial wall traumaMGuard’s net diffuses the stent pressure, creating a snow shoe effect to lower vessel trauma and injury*.This leads to a reduction in restenosis compared to BMS**.
9About MGuard’s Clinical Benefits Maintaining standard procedureMGuard’s standard crossing profile and dilatationpressures make deliverability and deployment equivalent to a conventional balloon inflated stent.
10MGuard Trials Preclinical - Coronary Porcine Study MGuard FIM Trial The GUARD Trial - Brazil Multicenter StudyThe MAGICAL Study MGuard in Acute MI TrialiMOS – MGuard International Registry
11Animal Trials Porcine studies by CBSET Inc. Cambridge, MA A comparison of MGuard with standard BMSMethods9 Swine with a total of 21 stents:5 MGuard, 6 BMS (control)6 Month FUTrial ResultsNo animal morbidityNo device thrombosisLow inflammatory response (0.8 ± 0.3 on a scale of 0-3)Low Schwartz injury score (0.15 ± 0.1)Exceptionally good endothelization (4 ± 0)
12Preclinical Safety Study Histology: 30 Days Post-Implantation 10X BMSMGuard
16MGuard First in Man Study Primary endpoint: 30 days MACESecondary endpoints:Device successProcedural successTIMI flow post procedure6 Months MACE6 Months Late Lumen LossParticipating centers:Eberhard Grube ; Helios Heart Center, Siegburg, GermanyKarl Eugen Hauptmann ; Trier, Germany
17FIM Clinical ResultsProtocol amended to obtain long term (> 1y) results – Results expected by April 2009
18Case Report #1 - MGuard in SVG 78 year old female with history of hypercholesterolemia, hypertension, smoking and diabetes.Coronary artery bypass surgery in 1993 and presented with progressive angina (CCS-III).Coronary angiography revealed subtotal occluded (99%) vein graft to the Right Coronary Artery.2 MGuard stents were implantedProcedural success with:No clinical adverse eventsNo CPK riseNo no-reflow post PCI
19Case Report #1 - MGuard in SVG Pre-PCIPOSTMGuard
20Case Report #2 - MGuard in SVG with IVUS 60 year old maleProximal SVG (1995) lesion4mm lumen diameter80% stenosis4X15 MGuard stent6 monthsNo ISA;% St obstruction = 17%BaselineNo ISA;St expansion= 98.9%
21Case Report #3 - MGuard in Acute MI Totally Occluded LADThe Thrombus Visible
22Case Report #3 - MGuard in Acute MI Final ResultThe procedure was completed withoptimal results and an absence ofany angiographic complications.