BETTER BY DESIGN. BACKED BY DATA. · stUDY resULts SY CONCLUSION:tUD In this single-arm study, treatment with the Solitaire™ [stent thrombectomy device] in intracranial anterior

Solitaire™ Revascularization Device

BETTER BY DESIGN. BACKED BY DATA.

Positive Clinical Outcomes(mRS 0-2) 1

60%Solitaire™ Device Utilization in SWIFT PRIME 1

100%

0%Symptomatic Intracerebral Haemorrhage sICH 1

Solitaire™ Overlapping Parametric™ Design

1. Saver JL, Goyal M, Bonafe A, et al. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N. Engl. J. Med. Jun 11 2015;372(24):2285-2295.

Solitaire™

Revascularization Device

Primary interventional technique:

characteristic solitaire™ Device

Number 202

Age Yr. - Median (IQR) 72 (25, 86)

Female sex – % 60

Baseline NIHSS - Median (IQR) 17 (8, 26)

History of hypertension – % (no./total) 63 % (127/202)

History of diabetes – % (no./total) 15 % (30/202)

Onset to groin puncture mins - Median (IQR) 238 (72, 714)

Most Proximal Occlusion Location * – % (no./total)

Intracranial ICA 18 % (36/196)

M1-MCA 67 % (131/196)

M2-MCA 14 % (28/196)

Other 0.5 % (1/196)

* Core laboratory missing most proximal occlusion location for 6 subjects.

Solitaire™

Revascularization device

(100 %)

starKEY FINDINGSSolitaire flow restoration Thrombectomy for Acute Revascularization (STAR) Study

Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire™ [stent thrombectomy device] in patients with acute ischemic stroke.

IV-t-PA RANDOMIZED LESS tHAN 5% LOSS tO FOLLOW UP INDEPENDENt DAtA REVIEW

StUDY PURPOSE: The STAR Study was an international, multicenter, prospective, single-arm study of the use of the Solitaire™ stent retriever device in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary end point was the revascularization rate (thrombolysis in cerebral infarction ≥2b) of the occluded vessel as determined by an independent core laboratory. The secondary end point was the rate of good functional outcome (defined as 90-day modified Rankin scale, 0-2).

Baseline Demographics:

solitaire™


stUDY resULts

StUDY CONCLUSION: In this single-arm study, treatment with the Solitaire™ [stent thrombectomy device] in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days.

OUtcOMe

Successful revascularization (assigned as TICI ≥ 2b up to 3 passes) as per core laboratory - % (no./total)

79.2 % (160/202)

mRS 0-2 at 90 days - % (no./total) 57.9 % (117/202)

Death from any cause at 90 days - % (no./total) 6.9 % (14/202)

Symptomatic Intracranial hemorrhage per CEC adjudication - % (no./total) 1.5 % (3/202)

SOURCE: Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. Pereira VM et al; Stroke. 2013 Oct;44(10):2802-7.

INDICAtION: The Solitaire™ Platinum Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.The Solitaire™ Platinum Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

17 26 15 16 415 7

0 %

90 day mRS (n=202)

58 %

20 % 40 % 60 % 80 % 100 %

mrs 0-2 mrs 3-6

UC201802906 EE © Medtronic 2018. All rights reserved. Printed in Europe.

Medtronic GmbHEarl-Bakken-Platz 140670 Meerbusch [email protected] Telefon: +49 (0)2159 81 49 0 Telefax: +49 (0)2159 81 49 100

www.medtronic.de

97%RetRievable

Stent (190/196)

0.5%thrombolytics Only (1/196)

2.6%Other Mechanical (5/196)

MR CLEANKEY FINDINGSA randomized trial of intra-arterial treatment for acute stroke

A prospective, multi-center, randomized, controlled, blinded-endpoint trial. 500 patients with a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially, were enrolled in 16 medical centers in the Netherlands within 6 hours after symptom onset.

No significant difference in baseline characteristics between study arms:


n = 196(of the 233 assigned to intervention,

only 196 underwent intervention therapy)

ChARACtERistiC CONtROL(N=267)

iNtERVENtiON(N=233)

age in years - median 65.7 65.8

Male sex – no. (%) 157 (58.8%) 135 (57.9%)

niHSS score – median (iQR) 18 (14 - 22) 17 (14 - 21)

Treatment with IV alteplase – no. (%) 242 (90.6%) 203 (87.1%)

time from onset to start of iv alteplase – minutes median (iQR)

87 (65 - 116) 85 (67 - 110)

time from onset to randomization – minutes median (iQR)

196 (149 – 266) 204 (152 – 251)

time from onset to groin puncture – minutes median (iQR)

n/a 260 (210 – 313)

Intracranial Arterial Occlusion Location – no. (%)

ICA – no. (%) 3 (1.1%) 1 (0.4%)

ICA – T – no. (%) 75 (28.2%) 59 (25.3%)

M1 segment – no. (%) 165 (62.0%) 154 (66.1%)

M2 segment – no. (%) 21 (7.9%) 18 (7.7%)

A1/2 segment – no. (%) 2 (0.8%) 1 (0.4%)


StUDY PURPOSE: In patients with acute ischemic stroke caused by proximal intracranial arteal occlusion, intra-arterial treatment (IAT) is highly effective for emergent revascularization. However, proof of a beneficial effect on functional outcome is lacking. 500 patients with a proximal arterial occlusion in the anterior cerebral circulation demonstrated on vessel imaging, treated with IAT within 6 hours were randomized to IAT plus usual care (IV-TPA or medical management) or usual care alone.

OUtCOME CONtROL (n=267)

iNtERVENtiON (n=233) P-Value* Odds Ratio **

Modified Rankin Scale (mRS) score 0-2 at 90 days - no. (%)

51 (19.1%) 76 (32.6%) Ø 2.05 (1.36 - 3.09)

TICI classification 2b-3 – no./total (%) (Corelab) n/a 115/196 (58.7%) n/a n/a

Death within 30 days – no. (%) 49 (18.4%) 44 (18.9%) nS Ø

Symptomatic intracranial Hemorrhage (SITS-MOST) – no. (%)

17 (6.4%) 18 (7.7%) not reported Ø

*p < 0.05 means there is a significant difference**Odds Ratio > 1 means there is a significant difference

stUDY REsULts

Significant improvement in functional outcomes at 90 days observed with the addition of interventional therapy.

StUDY CONCLUSION: Intra-arterial treatment in patients with acute ischemic stroke caused by proximal intracranial occlusion of the anterior circulation is effective and safe within 6 hours after stroke onset.

SOURCE: A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke, Olvert A. Berkhemer, Puck S.S. Fransen, Debbie Beumer, et al, The New England Journal of Medicine, Massachusetts Medical Society, Jan 1, 2015

INDICAtION: The Solitaire™ Platinum Revascularization Device is designed for use in the flow restoration of patients with ischemic strokedue to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.The Solitaire™ Platinum Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.


mRs 0-2 mRS 3-6

3

6 13 16

9 21 18 22

1230 22

6 21

0 %

inteRventiOn(n=233)

32,6 %

19,1 %

COntROl(N=267)

20 % 40 % 60 % 80 % 100 %



www.medtronic.de


StUDY PURPOSE: Recent technological advances have demonstrated the superiority of retrievable stents over previous generation thrombectomy devices. The recently reported MR CLEAN study was the first randomized trial to widely use this technology and reported clinical benefit of endovascular treatment in patients with proximal intracranial occlusion. The ESCAPE Trial sought to prove that selected patients using CT and CTA with rapid, team based endovascular treatment using modern endovascular techniques is an efficacious treatment for patients with acute ischemic stroke.

INTERVENTION CONTROL INTERVENTION

Number 150 165

Age. Yr. Median (IQR) 70 (60-81) 71 (60-81)

Female sex – no. (%) 79 (52.7 %) 86 (52.1 %)

NIHSS score - Median (IQR) 17 (12-20) 16 (13-20)

History of hypertension – no. (%) 108 (72.0 %) 105 (63.6 %)

History of diabetes – no. (%) 39 (26.0 %) 33 (20.0 %)

Onset to randomization mins – Median (IQR) 172 (119–284) 169 (117–285)

Site of vessel occlusion – no. (%)

ICA with M1 MCA 39 (26.5 %) 45 (27.6 %)

M1 or all M2 MCA 105 (71.4 %) 111 (68.1 %)

M2-MCA 3 (2.0 %) 6 (3.7 %)

No significant difference in study populations:


thrombectomy device used:

Other stent retriever(23 %)

Other endovascular device(14 %)

SOLITaIRE™ DEVICE(77 %)

STENTRETRIEVERDEVICE (86 %)

ESCaPEKEY FINDINGSEndovascular treatment for small core and proximal occlusion ischemic stroke

An investigator-initiated, multi-center, prospective, randomized, open-label, blinded-endpoint (PROBE) study in ischemic stroke patients. Patients were allocated 1:1 to endovascular treatment plus guideline- based standard care (intervention) vs guideline- based standard care alone (control).

OUTCOME CONTROL(n = 150)

INTERVENTION(n = 165) P-Value*

mRS 0-2 at 90 days - % (no./total) 29.3 % (43/147) 53.0 % (87/164) <0.001

Final end of procedure reperfusion (TICI 2b+3) - % (no./total)

N/A 72.4% (113/156) N/A

Death - % (no./total) 19.0 % (28/147) 10.4 % (17/164) 0.04

sICH (at 24 hours) - % (no.) 2.7 % (4) 3.6 % (6) 0.75

Statistically significant improvement in rate of good outcomes at 90 days with intervention.

*p < 0.05 means there is a significant difference

StUDY CONCLUSION: Among patients with acute ischemic stroke with a proximal vessel occlusion, a smallinfarct core, and moderate-to-good collateral circulation, rapid endovascular treatment (with the Solitaire™ stent thrombectomy device as recommended primary technique) improved functional outcomes and reduced mortality.

15

7 10 12

21 18 16 13

1215 24 19

7 10

0 %

Intervention (n=164)

53 %

29,3 %

Control (n=147)

20 % 40 % 60 % 80 % 100 %mRS 0-2 mRS 3-6

STUDY RESULTS

SOURCE: Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke, Mayank Goyal, Andrew M. Demchuk, Bijoy K. Menon, et al The New England Journal of Medicine Massachusetts Medical Society, Mar 12, 2015

INDICAtION: The Solitaire™ Platinum Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Solitaire™ Platinum Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.




www.medtronic.de


Solitaire™ Revascularization

Device (100 %)

EXTEND-IAKEY FINDINGSExtending the Time for Thrombolysis in Emergency Neurological Deficits – Intra-Arterial

An investigator-initiated, multi-center, prospective, randomized, open-label, blinded-endpoint (PROBE) study in ischemic stroke patients receiving intravenous alteplase within 4.5 h of stroke onset.


StUDY PURPOSE: The EXTEND-IA trial [was conducted] to test the hypothesis that anterior circulationischemic stroke patients, selected with a « dual target » of vessel occlusion and evidence of salvageabletissue on perfusion imaging within 4.5 h of onset, would have improved reperfusion and early neurologicalimprovement when treated with endovascular thrombectomy using the Solitaire™ stent thrombectomydevice after intravenous (IV) alteplase, compared to alteplase alone.


CHARACTERISTICIntravenous t -PA Alone

(n=35)

Combined Intravenous t -PA and Endovascular

Therapy (n=35)

Age. Yr. mean (SD) 70.2 (11.8) 68.6 (12.3)

Male sex – no. (%) 17 (49 %) 17 (49 %)

NIHSS score, Median (IQR) 13 (9 – 19) 17 (13 – 20)

History of hypertension – no. (%) 23 (66 %) 21 (60 %)

History of diabetes – no. (%) 8 (23 %) 2 (6 %)

Time (min) from stroke onset to initiation of alteplase, Median (IQR)

145(105 – 180)

127(93 – 162)


Internal Carotid Artery (ICA) 11 (31 %) 11 (31 %)

First segment of Middle Cerebral Artery (M1) 18 (51 %) 20 (57 %)

Second segment of Middle Cerebral Artery (M2) 6 (17 %) 4 (11 %)

Solitaire™


26

17 11 11

26 20 17

1111 17 20

3 9

0 %

Combined Intravenoust-PA and EndovascularTherapy (n=35)

Intravenous t-PAAlone (n=35)

71 %

40 %

20 % 40 % 60 % 80 % 100 %

STUDY RESULTS

OUTCOMEIntravenous t -PA

Alone (n=35)

Combined Intravenous t -PA and Endovascular

Therapy (n=35)P-Value*

Final mTICI 2B+3 (in patients who had an angiogram with occlusion on initial run n=29) – no./total (%)

N/A 25/29 (86 %) N/A

Independent outcome (mRS 0-2) - no./total (%) 14/35 (40 %) 25/35 (71 %) 0.009

Death - no./total (%) 7/35 (20 %) 3/35 (9 %) 0.18

Symptomatic intracerebral hemorrhage - no./total (%) 2/35 (6 %) 0/35 (0 %) 0.49

Statistically significant improvement in rate of good outcomes at 90 days with intervention using the Solitaire™ Platinum Revascularization Device as primary treatment.

StUDY CONCLUSION: In ischemic stroke patients with a proximal cerebral arterial occlusion and salvageable tissue on CT perfusion imaging, early thrombectomy with the Solitaire™ stent retriever device improves reperfusion, early neurologic recovery and functional outcome compared with alteplase alone.

SOURCE: Endovascular Therapy for Ischemic Stroke with Perfusion-Imaging Selection Bruce C.V. Campbell, Peter J. Mitchell, Timothy J. Kleinig, et al The New England Journal of Medicine Massachusetts Medical Society Mar 12, 2015




mRS 0-2 mRS 3-6



www.medtronic.de


SWIFT PRIMEKEY FINDINGSSolitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke trial

A global multicenter, two-arm, prospective, randomized,open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either IV t-PA alone or IV t-PA in combination with the Solitaire™ device.


StUDY PURPOSE: To compare the functional outcomes in Acute Ischemic Stroke subjects treated with either IV t-PA alone or IV t-PA in combination with the Solitaire™ device.


CHARACTERISTICIntravenous t ‑PA Alone

(n=98)

Combined Intravenous t ‑PA and Endovascular

Therapy (n=98)

Age. Yr. mean (SD) 66.3 (11.3) 65.0 (12.5)

Male sex – no./total (%) 45/96 (47 %) 54/98 (55 %)

NIHSS score, Median IQR 17 (13 – 19) 17 (13 – 20)

History of hypertension – no./total (%) 56/97 (58 %) 66/98 (67 %)

History of diabetes – no./total (%) 15/97 (15 %) 12/98 (12 %)

Time (min.) from stroke symptoms onset to initiation of alteplase, Median IQR

117.0 (80 – 155)

110.5 (85 – 156)

Site of vessel occlusion – no./total (%)

Internal Carotid Artery (ICA) 15/94 (16 %) 17/93 (18 %)

First segment of Middle Cerebral Artery (M1) 72/94 (77 %) 62/93 (67 %)

Second segment of Middle Cerebral Artery (M2) 6/94 (6 %) 13/93 (14 %)

Solitaire™


Solitaire™ Revascularization

Device (100 %)

OUTCOMEIntravenous t ‑PA Alone

(n=98)

Combined Intravenous t ‑PA and Endovascular

Therapy (n=98)

P‑Value*

Modified Rankin Scale (mRS) score 0-2 at 90 days – no./total no. (%)33/93(35 %)

59/98 (60 %)

<0.001

Revascularization outcome

Substantial reperfusion immediately after thrombectomy – no./total no. (%)

N/A 73/83 (88 %) N/A

Successful reperfusion at 27 hr. – no./total no. (%) 21/52 (40 %) 53/64 (83 %) <0.001

Death at 90 days - no./total no. (%) 12/97 (12 %) 9/98 (9 %) 0.50

Symptomatic Intracranial Hemorrhage at 27 hr – no. (%)

3 (3 %) 0 (0 %) 0.12

Statistically significant improvement in the rate of good outcomes at 90 days using the Solitaire™ as primary treatment.


17

9 11 16

26 17 12

17 22 26

15 12

0 %

Stent Retriever + Intravenous t-PA (N = 98)

Intravenous t-PA (N = 93)

Patients (%)

60 %

35 %

20 % 40 % 60 % 80 % 100 %

mRS 0‑2 mRS 3‑6

STUDY RESULTS

StUDY CONCLUSION: In patients experiencing an acute ischemic stroke with confirmed largevessel occlusions of the anterior circulation, those treated with intravenous t-PA treatment with the Solitaire™ stent retriever device within 6 hours after symptom onset improved functional outcomes at 90 days.

SOURCE: Stent-Retriever Thrombectomy after Intravenous t-PA vs. t-PA Alone in Stroke Jeffrey L. Saver, Mayank Goyal, Alain Bonafe, et al Publication: The New England Journal of Medicine Massachusetts Medical Society Jun 11, 2015

INDICAtION: Please refer to the package insert for complete instructions, contraindications, warnings and precautions.The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hour of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.




www.medtronic.de


Solitaire™


(100 %)

REVASCATKEY FINDINGSRandomized trial of revascularization with the Solitaire™ device versus the best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within 8 hours of symptom onset

An investigator-initiated, multicenter, prospective, randomized, sequential, open-label study with blinded-endpoint (PROBE) in acute ischemic stroke patients who had contraindications to IV t-PA or had received IV t-PA therapy within 4.5 hours without revascularization after 30 minutes of IV t-PA.

IV-t-PA MEDICAL MANAGEMENt RANDOMIZED LESS tHAN 5% LOSS tO FOLLOW UP INDEPENDENt DAtA REVIEW

StUDY PURPOSE: The REVASCAT study [was conducted] to determine the efficacy and safety of neurovascular thrombectomy with the Solitaire™ device in conjunction with medical therapy versus medical therapy alone, among eligible acute ischemic stroke patients treatable within 8 hours of symptom onset.


ChARACTERiSTiC CONTROL iNTERVENTiON

Number 103 103

Age. Yr. mean (SD) 67.2 (9.5) 65.7 (11.3)

Male sex – no. (%) 54 (52.4 %) 55 (53.4 %)

NIHSS score, Median (IQR) 17 (12 – 19) 17 (14 – 20)

History of hypertension – no. (%) 72 (69.9 %) 62 (60.2 %)

History of diabetes – no. (%) 19 (18.4 %) 22 (21.4 %)

Time (min.) from stroke symptoms onset to initiation of alteplase, Median (IQR)

105 (86.0 – 137.5)

117.5 (90 – 150)


Internal Carotid Artery (ICA) 1 (1 %) 0 (0 %)

Terminus ICA with involvement of MCA M1 segment

27 (26.7 %) 26 (25.5 %)

MCA M1 segment 65 (64.4 %) 66 (64.7 %)

MCA single M2 segment 8 (7.9 %) 10 (9.8 %)

Solitaire™


STUDY RESULTS

StUDY CONCLUSION: In patients with anterior circulation stroke treatable within 8 hours of symptom onset, stent retriever thrombectomy with the Solitaire™ device reduces post-stroke disability.

OUTCOMECONTROL

(N = 103)iNTERVENTiON

(N = 103)

UNADJUSTED EFFECT

EFFECT VARiAbLE ODDS RATiO* (95 % CI)

Modified Rankin Scale (mRS) score 0-2 at 90 days – no. (%)

29 (28.2 %)

45 (43.7 %)

2.0(1.1 – 3.5)

TICI classification 2b-3 – no./total (%) (Corelab) N/A 67/102 (65.7 %) N/A

Death at 90 days – no. (%) 16 (15.5 %) 19 (18.4 %) 1.2 (0.6 – 2.2)

Symptomatic Intracranial Hemorrhage (SITS-MOST) – no. (%)

2 (1.9 %) 2 (1.9 %) 1.0 (0.1 – 7.0)

Statistically significant improvement in the rate of good outcomes at 90 days with intervention using the Solitaire™ device as primary treatment.

SOURCE: Thrombectomy within 8 Hours after Symptom Onset in Ischemic Stroke, Tudor G. Jovin, Angel Chamorro, Erik Cobo, et al, The New England Journal of Medicine, Massachusetts Medical Society, Jun 11, 2015.



*Odds Ratio > 1 means there is a significant difference

6.8

5.8 6.8 15.5

17.5 19.4 18.4

20.419.4 16.5 15.5

7.8 11.7 18.4

0 %

Intervention(n=103)

Control(n=103)

Patients (%)

43.7 %

28.2 %

20 % 40 % 60 % 80 % 100 %

mRS 0-2 mRS 3-6



www.medtronic.de

Intravenous thrombolysis with alteplase alone cannot reperfuse most large-artery strokes. We present a study which aimed to determine whether mechanical thrombectomy in addition to intravenous thrombolysis improves clinical outcome in patients with acute ischaemic stroke.

STUDY PURPOSE: THRACE is a randomized controlled trial done in 26 centres in France. 402 patients aged 18–80 years with acute ischemic stroke and proximal cerebral artery occlusion were randomly assigned to receive either intravenous thrombolysis alone (IVT group) or intravenous thrombolysis plus mechanical thrombectomy (IVTMT group).Intravenous thrombolysis had to be started within 4 h and thrombectomy within 5 h of symptom onset. The primary outcome was the proportion of patients achieving functional independence at 3 months, defined by a score of 0–2 on the modified Rankin scale, assessed in the modified intention-to-treat population.

Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke

THRACE KEY FINDINGS

IV-T-PA RANDOMIZED

LESS THAN 5% LOSS TO FOLLOW UP

INDEPENDENT DATA REVIEW

SOLITAIRE™ DEVICE

93%

OTHER STENT RETRIEVERS7%

No significant difference in baseline characteristics between study arms:


CHARACTERISTIC IVT GROUP IVTMT GROUP

Number 208 204

Age. Yr. Median (IQR) 68 (54-75) 66 (54-74)

Female sex - % 50 43

Baseline NIHSS, Median (IQR) 17 (13 -20) 18 (15 -21)

History of hypertension - % (no./total) 57% (118/208) 47% (96/200)

History of diabetes - % (no./total) 17% (35/208) 8% (17/204)

Onset to randomization mins - Median (IQR) 170 (138–199) 168 (143–195)

Occlusion site - no. (%)

ICA 39 (19%) 24 (12%)

M1 164 (79%) 176 (86%)

M2 2 (1%) 0 (0%)

Other 2 (1%) 2 (1%)

Conclusion: In this comparative study, mechanical thrombectomy combined with standard intravenous thrombolysis improves functional independence in patients with acute cerebral ischemia, with no evidence of increased mortality.

OUTCOME IVT GROUP (n=208)

IVTMT GROUP (n=204) P-Value*

mRS 0-2 at 90 days - % (no./total) 42% (85/202) 53% (106/200) 0.028

Death from any cause at 90 days - % (no./total) 13% (27/206) 12% (24/202) 0.70

Symptomatic Intracranial hemorrhage per CEC adjudication - % (no./total) 2% (3/192) 2% (4/185) 0.71

mTICI 2b-3 - % N/A 69% N/A

STUDY RESULTS

15

12 16 14

20 18 12 17

52812 13

6 12

0 %

IVTMT GROUP(N=200)

53 %

42 %

IVT GROUP(N=202)

20 % 40 % 60 % 80 % 100 %

SOURCE: Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomised controlled trial, Serge Bracard, Xavier Ducrocq, Jean Louis Mas et al., Lancet Neurol 2016; 15: 1138–47.

INDICATIONS: The Solitaire™ Platinum Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Solitaire™ Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.



mRS 0-2 mRS 3-6

UC201802098EE - © Medtronic 2018.All rights reserved. Printed in Europe.


www.medtronic.de

A randomized, open-label, blinded end-point clinical trial in ischemic stroke patients with large vessel occlusion in the anterior circulation. Patients within 6 hours of symptom onset were included, in 8 comprehensive stroke centers in France.

STUDY PURPOSE: This study aims to compare efficacy and adverse events using the contact aspiration technique (ADAPT) vs the standard stent retriever technique as a first-line endovascular treatment for successful revascularization among patients with acute ischemic stroke and large vessel occlusion.

A direct aspiration first-passtechnique (ADAPT), for Thrombectomy Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

ASTER Key Findings

ADAPT vS. STEnT RETRiEvER RAnDOmizED



PRImARy ENDPoINT mET*

No significant difference in study populations*

Primary interventional technique among patients assigned to first-line stent retriever:

*Patients who received stent retriever as frontline strategy

chARAcTERiSTic First-Line ContaCt aspiration(n = 192)

First-Line stent retriever (n = 189)

Age - mean (SD), yrs 71.7 (13.8) 68.1 (14.6)

men - no./total (%) 103/192 (53.7%) 104/189 (55.0%)

NIHSS score - mean (SD) 16.3 (5.9) 16.1 (6.5)

History of hypertension - no./total (%) 118/186 (63.4%) 111/187 (59.4%)

History of diabetes - no./total (%) 36/185 (19.5%) 40/188 (21.3%)

Time (min.) from stroke symptoms onset to groin puncture - median (IQR)

217 (166-279) 235 (186-283)

Site of occlusion - no./total (%)

m1 of mCA 100/174 (57.5%) 104/176 (59.1%)

m2 of mCA 48/174 (27.6%) 31/176 (17.6%)

ICA 22/174 (12.6%) 33/176 (18.7%)

other 4/174 (2.3%) 8/176 (4.6%)

*�absolute�difference�of�15%�in�TICI2b/3�successful�revascularization�at�the�end of the treatment

*except for age and site of occlusion

SoLITAIRE™ DEVICE67%*

other stent retrievers

33%

stUDY ConCLUsion: Among patients with ischemic stroke in the anterior circulation undergoing thrombectomy, first-line thrombectomy with contact aspiration compared with stent retriever did not result in an increased successful revascularization rate at the end of the procedure. AsTeR is a negative study as it failed to meet the primary study objective (TiCi 2b/3 superiority). it is not a study demonstrating equivalence between aspiration and stent retriever revascularization results. Functional independence outcomes (mRs at 90 days) are favorable to stent retriever.

OUTcOmE First-Line Contact aspiration (n = 192)

First-Line stent retriever (n = 189) p-value*

Functional independence at 3 months (mRS score 0-2) - no./total (%) 82/181 (45.3%) 91/182 (50.0%) 0.38

mRS score 0-1 - % 33% 43% 0.04

mRS score 0 - % 13% 22% 0.029

mTICI score of 2b-3 assessed by core laboratory - no./total (%) 164/192 (85.4%) 157/189 (83.1%) 0.53

Death from any causes at 3 months – no./total (%) 35/181 (19.3%) 35/182 (19.2%) NS

Symptomatic intracranial hemorrhage at 24h – no./total (%) 10/188 (5.3%) 12/188 (6.5%) 0.63

stUDY resULts

24

40 38 13

35 23 25 25

131726 35

14 35

0 %

First-Line Contact Aspiration (n=181)

45.3 %

50 %

First-Line Stent Retriever�(n=182)

20 % 40 % 60 % 80 % 100 %

SOURcE: Effect of Endovascular Contact Aspiration vs Stent Retriever on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion (the ASTER Randomized Clinical Trial), Bertrand Lapergue, Raphael Blanc, Benjamin Gory et al. Journal of the American Medical Association, Aug 1st 2017.

INDIcATION: The Solitaire™ Platinum Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.The solitaire™ Platinum Revascularization device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

*�p�<�0.05�means�there�is�a�significant�difference

mrs 0-2 mRS 3-6

UC201806464EE - © Medtronic 2018.All rights reserved. Printed in europe.


www.medtronic.de

Prospective, single arm, observational, non-randomized, multicenter study Patients with acute ischemic stroke due to large vessel occlusion treated within 8 hours from stroke onset with the Solitaire™ device, at 55 centers across the US.

STUDY PURPOSE:

1)EvaluatetheclinicalefficacyandsafetyofmechanicalthrombectomywiththeSolitaire™orMindframeCapture™LPdevicesinthetreatmentofpatientswithAISduetoLVO.

2)Analyzetheeffectofinterhospitaltransferontimetoendovascular treatment and clinical outcomes in a large cohort of stroke patients.

3) Evaluate the angiographic and clinical outcomes based on differentadjunctivetechniqueapproaches

PrimaryOutcomeResultsOfTheSystematicEvaluationOfPatientsTreatedWithNeurothrombectomyDevicesForAcuteIschemicStroke(STRATIS)Registry

STRATIS REGISTRY Key findings 1

IV-t-PA RANDOMIZED

LESSTHAN5%LOSSTOFOLLOWUP

indePendenT dATA ReVieW

sOLiTAiRe™ deViCe

97%

Mindframe Capture™ LP device 3%

MECHANICALTHROMBECTOMYDEVICESUSED:

chARAcTERISTIcSEER*

INtERVENtION(N = 401)

STRATIS(N = 984) P-VAluE**

Age (sd) 67.3 (12.7) 67.8 (14.7) 0.269

Male - no./total (%) 195/401 (48.6%) 533/984 (54.2%) 0.066

niHss score - Median (iQR) 17 (13, 20) 17 (13, 22) 0.042

History of hypertension – no./total (%) 254/401 (63.3%) 712/984 (72.4%) 0.001

History of diabetes – no./total (%) 48/380 (12.6%) 252/984 (25.6%) < 0.001

Current or former tobacco use – no./total (%) 129/351 (36.8%) 465/984 (47.3%) 0.001

iV-tPA delivered – no./total (%) 323/401 (80.5%) 628/982 (64.0%) < 0.001

Time from stroke onset to alteplase initiation (min) – Median (sd)

122.9 (49.2) 113.3 (50.5) 0.001

site of occlusion - no./total (%)

iCA terminus 73/401 (18.2%) 222/984 (22.6%) not reported

M1 285/401 (71.1%) 538/984 (54.7%) not reported

M2 33/401 (8.2%) 170/984 (17.3%) not reported

Others 0/401 (0.0%) 46/984 (4.7%) not reported

Solitaire™


*SEER = SWIFT PRIME, ESCAPE, EXTEND IA, REVASCAT**p<0.05meansthereisasignificantdifference

StuDY CONCluSION:DespiteenrollingapopulationwithhighermeanneurologicdeficitandmoreriskfactorsthanSEER,resultsdemonstratethatMTwithaMedtronicstentretrieverisbothsafeandeffective

The technical and clinical outcomes of the landmark trials using the same device can reproduced in a real-world setting.

OutCOME SEER Intervention STRATIS P-Value*

successful reperfusion (mTiCi 2b-3) - no./total (%) 285/372 (76.6%) 724/824 (87.9%) < 0.001

mRs 0-2 – no./total (%) 216/400 (54.0%) 512/906 (56.5%) 0.432

death at 90 days – no./total (%) 48/401 (12.0%) 142/984 (14.4%) 0.263

symptomatic intracranial Hemorrhage at 24 hours no./total (%) 10/401 (2.5%) 12/841 (1.4%) 0.248

StuDY RESultS

21

14 22 18

22 13 14 10

71216 12

4 16

0 %

sTRATis(n=906)

funCTiOnAL indePendenCe AT 90 dAys

56,5 %

54 %

seeR intervention(n=400)

20 % 40 % 60 % 80 % 100 %

SOURCE: Froehler MT, Saver JL, Zaidat OO, et al. Interhospital Transfer Prior to Thrombectomy is Associated with Delayed Treatment and Worse Outcome in the STRATIS Registry. Circulation. 2017;CIRCULATIONAHA.117.028920, originally published September 24, 2017.

Mueller-Kronast NH et al; Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke; Stroke. 2017;48:00-00.

indiCATiOns:TheSolitaire™PlatinumRevascularizationDeviceisdesignedforuseintheflowrestorationofpatientswithischemicstrokeduetolargeintracranialvesselocclusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.The Solitaire™ Platinum Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

TheMindFrameCapture™LPsystemisindicatedfortemporaryusetorestorebloodflowinthecerebralvasculatureofpatientssufferingfromanacuteischemicstroke. TheMindFrameCapture™LPsystemispositionedacrosstheembolusorbloodclotandisusedtofacilitatetherestorationofbloodflowandremovaloftheclotobstruction.TheMindFrameCapture™LPsystemisindicatedfor:Endovasculartemporaryuseinpatientswithacuteischemicstroke.Endovasculartemporaryusetorestorebloodflowinpatients who are experiencing symptoms of an acute ischemic stroke caused by an embolus in a cerebral vessel.


*p<0.05meansthereisasignificantdifference

mRS 0-2 mRS 3-6



www.medtronic.de

SOLITAIRE™ DEVICE

97%


MECHANICAL THROMBECTOMY DEVICES USED :

Prospective, single arm, observational, non-randomized, multicenter study.Patients with acute ischemic stroke due to large vessel occlusion treated within 8 hours from stroke onset with the Solitaire™ device, at 55 centers across the US.

STUDY PURPOSE:

1)Evaluatetheclinicalefficacyandsafetyofmechanicalthrombectomy with the Solitaire™ or Mindframe Capture™ LP devices in the treatment of patients with AIS due to LVO.

2)Analyzetheeffectofinterhospitaltransferontimetoendovasculartreatmentandclinicaloutcomesinalargecohortofstrokepatients.

3) Evaluate the angiographic and clinical outcomes based on differentadjunctivetechniqueapproaches

PrimaryOutcomeResultsOfTheSystematicEvaluationOfPatientsTreatedWithNeurothrombectomyDevicesForAcuteIschemicStroke(STRATIS)Registry

STRATIS REGISTRY KEy fInDIngS 2

IV-tPA RANDOMIZED

LESS THAN 5% LOSS TO FOLLOWUP

InDEPEnDEnT DATA REVIEW

chARAcTERISTIc tRANsfERt(N = 445)

DIREcT(N = 539) P-VAluE*

Age, yrs – Mean (SD) 66.9 (14.6) 68.5 (14.8) 0.10

Male sex - no (%) 245 (55.1%) 288 (53.4%) 0.61

nIHSS score - Median (IQR) 18.0 (13, 22) 17 (12, 21) < 0.001

History of hypertension – no. (%) 321 (72.1%) 391 (72.5%) 0.89

History of diabetes – no. (%) 108 (24.3%) 144 (26.7%) 0.38

Current or former tobacco use – no. (%) 222 (49.9%) 243 (45.1%) 0.13

IV-tPA delivered – no. (%) 299 (67.2%) 329 (61.0%) 0.044

Time from stroke onset to revascularization (min) - Median 312 202 < 0.0001

Solitaire™



Patients (%)

24

17 21 14

23 13 12 9

61116 15

3 16

0 %

DIRECT(n=498)

60%

52.2%

TRAnSfER(n=408)

20 % 40 % 60 % 80 % 100 %mRS 0-2 mRS 3-6

stuDY CONClusION:Inthislarge,real-worldstudy,interhospitaltransferwereassociatedwithsignificantdelaystotreatment,andsignificantlylowerchanceofgoodoutcome.

OutCOME tRANsfERt (n=445)

DIREcT (n=539) P-Value*

mRS 0-2 – no./total (%) 213/408 (52.2%) 299/498 (60.0%) 0.02

Excellent functional outcome (mRS 0-1) – no./total (%) 155/408 (38.0%) 236/498 (47.4%) 0.005

All causes mortality – % 13.7 15.0 0.56

stuDY REsults

SOURCE: Froehler MT, Zaidat OO, Aziz-Sultan MA, Klucznik RP, Saver JL, et al. Interhospital transfer prior to thrombectomy is associated with delayed treatment and worse outcomes in the STRATIS registry. Presented at: International Stroke Conference 2017; February 23rd 2017; Houston, TX.

INDICATION: The Solitaire™ Platinum RevascularizationDeviceisdesignedforuseintheflowrestoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.The Solitaire™ Platinum Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.


The MindFrame Capture™ LP system is indicated for temporaryusetorestorebloodflowinthecerebralvasculatureofpatientssufferingfromanacuteischemicstroke. The MindFrame Capture™ LP system is positioned across the embolus or blood clot and is used to facilitate the restoration ofbloodflowandremovaloftheclotobstruction.The MindFrame Capture™ LP system is indicated for: Endovascular temporary use in patients with acute ischemic stroke.Endovasculartemporaryusetorestorebloodflowinpatients who are experiencing symptoms of an acute ischemic stroke caused by an embolus in a cerebral vessel. labeling supplied with each device.




www.medtronic.de

SOLITAIRE™ DEVICE

97%


MECHANICAL THROMBECTOMY DEVICES USED :

Prospective, single arm, observational, non-randomized, multicenter studyPatients with acute ischemic stroke due to large vessel occlusion treated within 8 hours from stroke onset with the Solitaire™ device, at 55 centers across the US.

STUDY PURPOSE:

1)Evaluatetheclinicalefficacyandsafetyofmechanicalthrombectomy with the Solitaire™ or Mindframe Capture™ LP devices in the treatment of patients with AIS due to LVO.

2)Analyzetheeffectofinterhospitaltransferontimetoendovascular treatment and clinical outcomes in a large cohort of stroke patients.

3) Evaluate the angiographic and clinical outcomes based on different adjunctive technique approaches.

Primary Outcome Results Of The Systematic Evaluation Of Patients Treated With Neurothrombectomy Devices For Acute Ischemic Stroke (STRATIS) Registry

STRATIS REGISTRY KEy fInDIngS 3

IV-tPA RANDOMIZED


InDEPEnDEnT DATA REVIEW

chARAcTERISTIc BAllOON GuIDE CAthEtER (BGC)(N = 504)

DIRECt ACCEss CAthEtER (DAC)(N = 301) P-VAluE*

Age, yrs (SD) 67.7 (15.22) 68.7 (14.29) not reported

Male - no./total (%) 261/503 (51.9%) 162/302 (53.6%) not reported

nIHSS score - Mean (SD) 17.1 (5.34) 17.5 (5.50) not reported

IV-tPA delivered – no./total (%) 328/503 (65.2%) 195/302 (64.6%) not reported

Vessel treated on first pass - no./total (%)

ICA 105/504 (20.8%) 89/301 (29.6%) not reported

M1 300/504 (59.5%) 164/301 (54.5%) not reported

M2 98/504 (19.4%) 47/301 (15.6%) not reported

Others 1/504 (0.2%) 1/301 (0.3%) not reported

Time from puncture to revascularization (min) – Mean (IQR) 43.9 (26.10) 42.9 (30.93) 0.1336

number of device passes – Mean (SD) 1.7 (1.10) 2.0 (1.30) 0.0014

Solitaire™



61.8%

50.2 %

0 %

BgC VS. DAC mRS 0-2 at 90 dayS

Solitaire™ device + BgC

Solitaire™ device + DAC

20 % 40 % 60 %

(p=0.002)

stuDY CONClusION: Functional outcome (mRS) results at 90 days are better in Solitaire™ device + BGC vs. Solitaire™ device + Distal Access Catheter*

* STRATIS = 97% Solitaire™ device, 3% Mindframe Capture™ LP revascularization device

OutCOME BGc(n = 504)

DAc(n = 301) P-Value*

first pass, TICI 2b-3 – no./total (%) 339/502 (67.5%) 164/298 (55.0%) 0.0004

final, mTICI 2b-3 - no./total (%) 378/425 (88.9%) 215/244 (88.1%) 0.7458

mRS 0-2 – no./total (%) 291/471 (61.8%) 138/275 (50.2%) 0.002

Death at 90 days – % 16.1 14.9 0.55

Symptomatic Intracranial Hemorrhage at 24 hours - % 1.8 1.2 0.75

STUDY RESULTS


SOURCE: Froehler MT, Zaidat OO, Aziz-Sultan MA, Klucznik RP, Saver JL, et al. Interhospital transfer prior to thrombectomy is associated with delayed treatment and worse outcomes in the STRATIS registry. Presented at: International Stroke Conference 2017; February 23rd 2017; Houston, TX.

INDICATION: The Solitaire™ Platinum RevascularizationDeviceisdesignedforuseintheflowrestoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.The Solitaire™ Platinum Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

The MindFrame Capture™ LP system is indicated for temporaryusetorestorebloodflowinthecerebralvasculatureofpatientssufferingfromanacuteischemicstroke. The MindFrame Capture™ LP system is positioned across the embolus or blood clot and is used to facilitate the restoration ofbloodflowandremovaloftheclotobstruction.The MindFrame Capture™ LP system is indicated for: Endovascular temporary use in patients with acute ischemic stroke.Endovasculartemporaryusetorestorebloodflowinpatients who are experiencing symptoms of an acute ischemic stroke caused by an embolus in a cerebral vessel. labeling supplied with each device.




www.medtronic.de

Multi-center, prospective, randomized, controlled, blinded-endpoint, phase II/III (feasibility/pivotal) trial of thrombectomy for wake-up and late presenting acute ischemic stroke that follows an adaptive design based on Bayesian predictive probabilities allowing population enrichment.

STUDY PURPOSE: Demonstrate superior functional outcomes at 90 days with Trevo™ plus medical management compared to medical management alone in appropriately selected patients treated 6 to 24 hours after last seen well.

Diffusion-weighted imaging or computerized tomography perfusion assessment with clinical mismatch in the triage of wake up and late presenting strokes undergoing neurointervention with Trevo™ (DAWN) trial

DAWN KEY FINDINGS

IV-TPA RANDOMIZED



No significant difference in study populations


Stroke symptoms on awakening:

CHARACTERISTIC TREATMENT ARM(N=107)

CONTROL ARM(N=99)

Age, yrs - Mean (SD) 69.4 (14.1) 70.7 (13.2)

Sex, male - % 39 52

Baseline NIHSS - Median ( IQR) 17 (13 – 21) 17 (14 – 21)

IV-tPA administrated - % 5 13

History of hypertension -% 78 76

History of diabetes - % 24 31

Time since time last seen well to randomization (hours) –Median (IQR)

12.2 (10.2 - 16.3) 13.3 (9.4 - 15.8)

Infarct volume, cc - Median (IQR) 7.6 (2.0 - 18.0) 8.9 (3.0 - 18.1)

Clot location - %

ICA 21 19

M1 78 78

M2 2 3

Alternative endovascular reperfusion devices3%

Other types of stroke 37%

STENT RETRIEVER (TREVO™)

97%

WAKE-UP STROKE

63%

STUDY CONCLUSION: Thrombectomy with Trevo™ in DAWN-eligible patients is associated with improvement in clinical outcomes with higher rates of functional independence (mRS 0-2) compared to standard medical therapy. The treatment effect size in DAWN is the highest out of any stroke trials to date and suggests that the presence of Clinical-Core Mismatch is a critical predictor of treatment effect independent of time to presentation.

STUDY RESULTS

SOURCE: Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct, R.G. Nogueira, A.P. Jadhav et al., The New England Journal of Medicine Massachusetts Medical Society Nov 11, 2017.

DISCLAIMER: Stryker Corporation or its divisions or other corporate affiliated entities own, use, or have applied for the following trademarks or services marks: Trevo™, trademarks are trademarks of their respective owners or holders.


*p < 0.05 means there is a significant difference** Similar to p < 0.0001

mRS 0-2 mRS 3-6

OUTCOME Treatment arm(n=107)

Control arm(n=99) P-Value* Bayesian probability of

superiority

Post-procedure mTICI ≥ 2b - % 84.0 N/A N/A Not reported

mRS 0-2 at 90 days - % 49 13 Not reported > 0.9999**

Stroke related mortality - % 16.0 18.0 NS Not reported

sICH - % 6.0 3.0 NS Not reported

Infarct volume at 24h, ml - Median (IQR) 8 (0 - 48) 22 (8 - 68) < 0.001 Not reported

0 %

Treatment arm (n=107)

49%

13%

Control arm (n=99)

20 % 40 % 60 % 80 % 100 %

9

4

22

5

17

4

13

16

13

34

26

36




www.medtronic.de

A multicenter, randomized, open-label, blinded-endpoint trial. 182 patients with proximal middle cerebral-artery or internal-carotid-artery occlusion, an initial infarct size of less than 70 ml and a ratio of the volume of ischemic tissue on perfusion imaging to infarct volume of 1.8 or more (calculated with the use of RAPID software (iSchemaView)), were enrolled in 38 U.S centers 6 to 16 hours after they were last known to have been well.

STUDY PURPOSE:

Thrombectomy is currently recommended for patients with stroke who are treated within 6 hours after onset. However, the results of the DAWN trial showed that the time window for endovascular treatment may be extended to 24 hours after the patient was last known to be well if patients are carefully selected on the basis of a disproportionately severe clinical deficit in comparison with the size of the stroke on imaging.The DEFUSE 3 trial enrolled patients who were likely to have salvageable ischemic brain tissue as identified by perfusion imaging and who underwent endovascular therapy 6 to 16 hours after they were last known to have been well, allocated to endovascular therapy plus medical therapy or medical therapy alone.

Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging

DEFUSE 3 Key findings

IV-TPA RANDOMIZED

LESS THAN 5% LOSS TO FOLLOW UPindePendenT dATA ReVieW

CHARACTERISTICENDOVASCulAR

THERAPy(N=92)

MEDICAl THERAPy(N=90)

Age, yrs - Median (iQR) 70 (59 – 79) 71 (59 – 80)

sex, female - no. (%) 46 (50%) 46 (51%)

Baseline niHss - Median (iQR) 16 (10 – 20) 16 (12 – 21)

Treatment with iVt-PA - no. (%) 10 (11%) 8 (9%)

stroke onset witnessed - no. (%)

yes 31 (34%) 35 (39%)

no

symptoms were present on awakening 49 (53%) 42 (47%)

symptoms began during wakefulness 12 (13%) 13 (14%)

Time from stroke onset to randomization, hr:min - Median (iQR) 10:53 (8:46 – 12:21) 10:44 (8:42 – 13:04)

Volume of ischemic core, ml - Median (iQR) 9.4 (2.3 – 25.6) 10.1 (2.1 – 24.3)

Occlusion site on baseline CTA or MRA - no. (%)

iCA 32 (35%) 36 (40%)

MCA 60 (65%) 54 (60%)

Others (20%)

sTenTs ReTRieVeRs(80%)


Stroke onset distribution in the Endovascular therapy arm:

no: symptoms began during wakefulness (13%)

yes(34%)

nO: syMPTOMs PResenT On AWAKening

(53%)

No significant difference in study populations

STuDy CONCluSION: Endovascular thrombectomy for ischemic stroke 6 to 16 hours after a patient was last known to be well plus standard medical therapy resulted in better functional outcomes than standard medical therapy alone among patients with proximal MCA or ICA occlusion and a region of tissue that was ischemic but not yet infarcted.

OuTCOME Endovascular Therapy (n=92)

Medical Therapy (n=90) P-Value*

TiCi score of 2b-3 – no./total (%) 69/91 (76%) nA nA

mRs 0-2 at 90 days – no. (%) 41 (45%) 15 (17%) < 0.001

death at 90 days – no. (%) 13 (14%) 23 (36%) 0.05

siCH – no. (%) 6 (7%) 4 (4%) 0.75

infarct volume at 24h, ml – Median (iQR) 35 (18 – 82) 41 (25 – 106) 0.19

STuDy RESulTS


SOUrcE: Albers GW, Marks MP, Kemp S, et al., on behalf of the DEFUSE 3 Investigators. Thrombectomy for stroke at 6 to 16 hours with selection by perfusion imaging. New England Journal of Medicine 2018, Jan 24

indiCATiOns: The Solitaire™ Platinum Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion.

Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Solitaire™ Platinum Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.



endOVAsCulARTHeRAPy(n=92)

MediCAlTHeRAPy(n=90)

10 16 18 15 18

8 4 4 2716

8 14

16 26

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

mRS 0-2 mRS 3-6

45%

17%

UC201808725EE © Medtronic 2018.All rights reserved. Printed in Europe.


www.medtronic.de

NOTES

NOTES

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Documents

BETTER BY DESIGN. BACKED BY DATA. · stUDY resULts SY CONCLUSION:tUD In this single-arm study, treatment with the Solitaire™ [stent thrombectomy device] in intracranial anterior