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For SVG Distal embolisation No reflow High rate of restenosis

PCI Unmet Clinical Needs. 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.

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For SVG Distal embolisation No reflow High rate of restenosis

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  1. PCI Unmet Clinical Needs • 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

  2. The Evolution of Stents 1st Generation While addressing the restenosis problem, today's stent technology overlooks the adverse effects of acute embolization 2nd Generation Drug Eluting Bare Metal MGuard 3rd Generation

  3. About MGuard’s Technology • 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

  4. 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

  5. About MGuard’s Clinical Benefits MGuard is designed to Trap thrombotic material to protect bloodstream from embolic debris Reduce vessel injury and restenosis rate Maintain standard procedure Injury lowered by MGuard

  6. 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.

  7. 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**.

  8. 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.

  9. 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

  10. 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)

  11. Preclinical Safety Study Histology: 30 Days Post-Implantation 10X BMS MGuard

  12. Injury Score

  13. Inflammation Score

  14. Neointimal Thickness

  15. MGuard First in Man Study • 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

  16. FIM Clinical Results • Protocol amended to obtain long term (> 1y) results – Results expected by April 2009

  17. 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

  18. Case Report #1 - MGuard in SVG Pre-PCI POST MGuard

  19. Case Report #2 - MGuard in SVG with IVUS • 60 year old male • Proximal SVG (1995) lesion • 4mm lumen diameter • 80% stenosis • 4X15 MGuard stent • 6 months • No ISA; • % St obstruction = 17% • Baseline • No ISA; • St expansion= 98.9%

  20. Case Report #3 - MGuard in Acute MI Totally Occluded LAD The Thrombus Visible

  21. Case Report #3 - MGuard in Acute MI Final Result The procedure was completed with optimal results and an absence of any angiographic complications.

  22. MGuard Technical Data • Stent : • Stent material: Stainless steel 316 • Stent design: Low profile • Strut thickness: 100μm, low profile stent design. • Catheter: • Rapid exchange delivery system • 0.014” guide wire compatible • Guiding catheter: 6F • Nominal Pressure: 6 atm. • Rated Burst Pressure: ≤ 3.0 mm: 16 atm. ≥ 3.5 mm: 14 atm. • Radio-opaque markers: Proximal and Distal • Balloon Characteristic: Semi - compliant • Usable Catheter Length: 1420 mm ± 20 mm

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