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For SVG Distal embolisation No reflow High rate of restenosis

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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. - PowerPoint PPT Presentation

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Page 1: For SVG Distal embolisation No reflow High rate of restenosis
Page 2: For SVG Distal embolisation No reflow High rate of restenosis

For SVGDistal embolisationNo reflowHigh rate of restenosis

For AMI / other thrombus loaded lesionsDistal embolisationNo reflow

Patients with DESLate ST due to incomplete endothelializationBleeding complications due to long term Plavix use

PCI Unmet Clinical Needs

Page 3: For SVG Distal embolisation No reflow High rate of restenosis

The Evolution of Stents

Bare Metal

Drug Eluting

1st

Generation

2nd Generation

MGuard Generation3rd

While addressing the restenosis problem, today's stent technology overlooks

the adverse effects of acute embolization

Page 4: For SVG Distal embolisation No reflow High rate of restenosis

• 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

Page 5: For SVG Distal embolisation No reflow High rate of restenosis

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

Page 6: For SVG Distal embolisation No reflow High rate of restenosis

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

Page 7: For SVG Distal embolisation No reflow High rate of restenosis

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.

Page 8: For SVG Distal embolisation No reflow High rate of restenosis

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**.

Page 9: For SVG Distal embolisation No reflow High rate of restenosis

About MGuard’s Clinical Benefits

Maintaining standard procedure

MGuard’s standard crossing profile and dilatationpressures make deliverability and deployment equivalent to a conventional balloon inflated stent.

Page 10: For SVG Distal embolisation No reflow High rate of restenosis

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

Page 11: For SVG Distal embolisation No reflow High rate of restenosis

Animal Trials

Porcine studies by CBSET Inc. Cambridge, MA A comparison of MGuard with standard BMS

Methods9 Swine with a total of 21 stents:5 MGuard, 6 BMS (control)6 Month FU

Trial ResultsNo animal morbidity No device thrombosisLow 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)

Page 12: For SVG Distal embolisation No reflow High rate of restenosis

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

BMS MGuard

Page 13: For SVG Distal embolisation No reflow High rate of restenosis

Injury Score

Page 14: For SVG Distal embolisation No reflow High rate of restenosis

Inflammation Score

Page 15: For SVG Distal embolisation No reflow High rate of restenosis

Neointimal Thickness

Page 16: For SVG Distal embolisation No reflow High rate of restenosis

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

Page 17: For SVG Distal embolisation No reflow High rate of restenosis

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

FIM Clinical Results

Page 18: For SVG Distal embolisation No reflow High rate of restenosis

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

Page 19: For SVG Distal embolisation No reflow High rate of restenosis

Case Report #1 - MGuard in SVG

Pre-PCI

POSTMGuard

Page 20: For SVG Distal embolisation No reflow High rate of restenosis

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%

Page 21: For SVG Distal embolisation No reflow High rate of restenosis

Case Report #3 - MGuard in Acute MI

Totally Occluded LAD The Thrombus Visible

Page 22: For SVG Distal embolisation No reflow High rate of restenosis

Case Report #3 - MGuard in Acute MI

Final ResultThe procedure was completed with optimal results and an absence of any angiographic complications.

Page 23: For SVG Distal embolisation No reflow High rate of restenosis

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

MGuard Technical Data