Transcript Diapositiva 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
The Evolution of Stents
Bare Metal
1st
Drug Eluting
2nd
MGuard
Generation
Generation
3rd Generation
While addressing the restenosis problem,
today's stent technology overlooks
the adverse effects of acute embolization
About MGuard’s Technology
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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
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The stent is wrapped with the ultrathin 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
Injury Score
Inflammation Score
Neointimal Thickness
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
FIM Clinical Results
• Protocol amended to obtain long term (> 1y) results – Results expected by April 2009
Case Report #1 - MGuard in SVG
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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
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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 LAD
The 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.
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