Presentation on theme: "For SVG Distal embolisation No reflow High rate of restenosis For AMI / other thrombus loaded lesions Distal embolisation No reflow Patients with DES."— Presentation transcript:
For SVG Distal embolisation No reflow High rate of restenosis For AMI / other thrombus loaded lesions Distal embolisation No reflow Patients with DES Late ST due to incomplete endothelialization Bleeding complications due to long term Plavix use PCI Unmet Clinical Needs
The Evolution of Stents Bare Metal Drug Eluting 1 st Generation 2 nd Generation MGuard Generation 3rd While addressing the restenosis problem, today's stent technology overlooks the adverse effects of acute embolization
Micron Circular Knitting Technology Net Material: Poly Ethylene Terephthalate (PET) Fiber diameter: 20 μm Aperture size at expanded state: ~180μm X 200μm System profile - 1.3mm Net secured to the distal and proximal end of the stent About MGuard’s Technology
The stent is wrapped with the ultra- thin polymer meshed net The net is designed for maximal flexibility without compromising the strength of the fiber The net expands seamlessly when the stent is deployed
About MGuard’s Clinical Benefits MGuard is designed to 1.Trap thrombotic material to protect bloodstream from embolic debris 2.Reduce vessel injury and restenosis rate 3.Maintain standard procedure Injury lowered by MGuard
About MGuard’s Clinical Benefits MGuard Lifelong Embolic Protection MGuard 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.
About MGuard’s Clinical Benefits Lower arterial wall trauma MGuard’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**.
About MGuard’s Clinical Benefits Maintaining standard procedure MGuard’s standard crossing profile and dilatation pressures make deliverability and deployment equivalent to a conventional balloon inflated stent.
MGuard Trials Preclinical - Coronary Porcine Study MGuard FIM Trial The GUARD Trial - Brazil Multicenter Study The MAGICAL Study MGuard in Acute MI Trial iMOS – MGuard International Registry
Animal Trials Porcine studies by CBSET Inc. Cambridge, MA A comparison of MGuard with standard BMS Methods 9 Swine with a total of 21 stents: 5 MGuard, 6 BMS (control) 6 Month FU Trial Results No animal morbidity No device thrombosis Low 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)
Preclinical Safety Study Histology: 30 Days Post-Implantation 10X BMS MGuard
Primary endpoint: 30 days MACE Secondary endpoints: Device success Procedural success TIMI flow post procedure 6 Months MACE 6 Months Late Lumen Loss Participating centers: Eberhard Grube ; Helios Heart Center, Siegburg, Germany Karl Eugen Hauptmann ; Trier, Germany MGuard First in Man Study
Protocol amended to obtain long term (> 1y) results – Results expected by April 2009 FIM Clinical Results
Case 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 implanted Procedural success with: No clinical adverse events No CPK rise No no-reflow post PCI
Case Report #1 - MGuard in SVG Pre-PCI POST MGuard
Case Report #2 - MGuard in SVG with IVUS 60 year old male Proximal SVG (1995) lesion 4mm lumen diameter 80% stenosis 4X15 MGuard stent Baseline No ISA; St expansion= 98.9% 6 months No ISA; % St obstruction = 17%
Case Report #3 - MGuard in Acute MI Totally Occluded LADThe Thrombus Visible
Case Report #3 - MGuard in Acute MI Final Result The procedure was completed with optimal results and an absence of any angiographic complications.