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
Pre-PCI
POST
MGuard

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