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PCI Unmet Clinical Needs

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Presentation on theme: "PCI Unmet Clinical Needs"— Presentation transcript:


2 PCI Unmet Clinical Needs
For SVG Distal embolisation No reflow High rate of restenosis For AMI / other thrombus loaded lesions Patients with DES Late ST due to incomplete endothelialization Bleeding complications due to long term Plavix use

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

4 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

5 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

6 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

7 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.

8 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**.

9 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.

10 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

11 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)

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

13 Injury Score

14 Inflammation Score

15 Neointimal Thickness

16 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

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

18 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

19 Case Report #1 - MGuard in SVG

20 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%

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

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

23 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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