APM0161/A/2612, 2006-09

The Merci® Retrieval System

Presentation prepared by Concentric Medical, September 2006

Not intended for distribution within the United States or Canada.

APM0161/A/2612, 2006-09

The Merci® System• Simple, elegant solution for ischemic stroke

– Retriever’s unique corkscrew design and Nitinol material enables the device to:

• straighten inside the catheter, then• return to its original shape when deployed

– This allows device to be delivered distal to thrombus using standard catheterization techniques

• Merci Retrieval System– Merci® Retriever– Merci® Microcatheter– Merci® Balloon Guide Catheter

APM0161/A/2612, 2006-09

Merci® Retriever Indications• The only thrombectomy device specifically

approved for the removal of thrombus in patients with ischemic stroke.– FDA cleared (August 2004) and approved in the EU via CE Mark.– The Merci Retriever has been used in > 3,000 patients and 200

centers since 2004.

• The Merci Retriever is intended to restore blood flow in patients experiencing ischemic stroke.  Patients who are ineligible for intravenous (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

• The Merci Retriever is also indicated for use in the retrieval of foreign bodies in the neuro, peripheral and coronary vasculature.

APM0161/A/2612, 2006-09

Mechanical RevascularizationFastest Way to Restore Flow

• Merci® Retriever is advanced (A)– through Microcatheter– distal to thrombus

• Retriever is deployed (B)– Retriever engages the thrombus– Microcatheter proximal to Retriever

• Captured thrombus is slowly removed (C)

– Balloon Guide Catheter provides proximal flow control

– Retriever and Microcatheter removed through Balloon Guide Catheter

A

B

C

APM0161/A/2612, 2006-09

MERCI Animation

APM0161/A/2612, 2006-09

Merci Provides Options• Location: Large Vessel Occlusion

– NIH Stroke Scale ≥ 12 is 91% predictive of large vessel occlusions

• Options: – Failed IV lytic cases– Ineligible for lytic:

• On oral anticoagulants• Recent surgery• Recent stroke• Symptom onset > 3 hours

• Time: Opening the Treatment Window

APM0161/A/2612, 2006-09

Opening the Time Window

Time from Stroke Onset

0-3 hrs 3-6 hrs >6 hrs‡

Options • IV Lytic• Merci • Merci

• IA Lytic†• Merci

† † Not FDA approved. Concentric does not endorse off-label useNot FDA approved. Concentric does not endorse off-label use‡‡ The MERCI and The MERCI and MultiMulti MERCI trials evaluated patients up to 8 hours MERCI trials evaluated patients up to 8 hours

APM0161/A/2612, 2006-09

Clinical Results

Successful Revascularization Post-Procedure Successful Revascularization Post-Retriever

60.3% (85/141) 48.2% (68/141)

Symptomatic Intracranial Hemorrhage (SICH) Rate SICH in MCA

7.8% (11/141)3.8% (3/80)

Mortality at 90 Days 43.5% (60/138)

Good Outcome (mRS ≤ 2) at 90 days 27.7% (36/130)

• MERCI clinical trial provided basis for FDA clearance– 141 patients treated in 25 U.S. stroke centers

APM0161/A/2612, 2006-09

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%45%

2%

35/78

1/52Revasc Non-Revasc

MERCI Post Procedure Status

Only one of the 52 MERCI non-revascularized patients had a good outcome

Revascularization Correlates with Good Outcome (90-Day mRS ≤ 2)

* P-values calculated as post-hoc analysis

p <0.0001*

APM0161/A/2612, 2006-09

30%

45%

8%

50%

20%

10%

10%

12%

13%

20%

26%

7%

25%

19%

80%

40%

65%

36%

67%

19%

0% 20% 40% 60% 80% 100%

Non-Revasc

Revasc

Non-Revasc

Revasc

Non-Revasc

Revasc

mRS 0-2mRS 3mRS 4-5Death

N=16N=16

N=12N=12

N=42N=42

N=31N=31

N=10N=10

N=5N=5

0-3 hrs

3-6 hrs

6+ hrs†

0-2 mRS difference p=0.0514

0-2 mRS difference p<0.0001

0-2 mRS difference p=0.4936

Revascularization Correlates with Good Outcome in All Time Windows*

*Anterior circulation only. P-values calculated as post-hoc analysis Duckwiler, ASITN Course & Workshops, August 2005

†The MERCI trial evaluated patients up to 8 hours

APM0161/A/2612, 2006-09

Typical Clots Retrieved

62 year-old Male ICA occlusion

History of atrial fibrillation

82 year-old FemaleMCA occlusion

History of atrial fibrillationFailed IV lytic

32 year-old Male Basilar occlusion

APM0161/A/2612, 2006-09

Not So Typical Clot Retrieved

APM0161/A/2612, 2006-09

Multi MERCI (Part I) Trial• 111 patients with angiographically proven large vessel

occlusive strokes were treated with the Merci® Retrieval System in 14 stroke centers

• Same study design as MERCI except:– Included failed IV lytic (t-PA) patients– Included next generation Merci Retriever L5

• Demographics:Age

Mean ± SD 66.2 ± 17.6Baseline NIHSS Score

Mean ± SD 19.0 ± 6.3Failed IV lytic (t-PA)

Percentage of Total 27% (30/111)

APM0161/A/2612, 2006-09

Multi MERCI (Part I) Trial

Revascularization Successful Revascularization Post-Procedure 69% (77/111)Successful Revascularization Post-Retriever 54% (60/111)

Symptomatic HemorrhageOverall 9.0% (10/111)Failed IV t-PA Patients 6.7% (2/30)

Good Outcome (90-day mRS ≤ 2) Overall 34% (37/108)

Mortality at 90 days Overall 31% (33/108)

APM0161/A/2612, 2006-09

Multi MERCI (Part I) Revascularization by Vessel

54% 52% 54% 60%

0%10%20%30%40%50%60%70%80%90%

100%

Overall Carotid MCA Posterior

Addtl. Revasc with Adjunctive Tx

N=111 N=33 N=68 N=10

69%69% 67%67%80%80%

69%69%

APM0161/A/2612, 2006-09

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

37/108

34.3%

47.3%

5.9%35/74

2/34

Revasc Non-Revasc

Overall

Post Procedure

Multi MERCI (Part I) Revascularization Correlates withGood Outcome (90-Day mRS ≤ 2)

* P-values calculated as post-hoc analysis

p<0.0001*

APM0161/A/2612, 2006-09

ConclusionMerci provides options:• Location

– Large Vessel Occlusion• Options

– Failed IV lytic cases– Ineligible for lytic

• Time: Opening the Treatment Window

Revascularization is the strongest predictor of good outcome.

The Merci procedure can dramatically improve patient outcome.