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24 февр. 2021 г.

InspireMD Engages Hart Clinical Consultants to Conduct Clinical Trial for CGuard Carotid Stent System in the United States

Tel Aviv, Israel – February 24, 2021 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today that it has engaged Hart Clinical Consultants (HCC), a leading Contract Research Organization (CRO) to conduct the clinical trial for its CGuard Carotid Stent System in the United States.

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24 февр. 2021 г.

Сделка активна

With this clinical trial result, better to consider their FDA approval in their hands:
Results
There were 729 patients (73.03 ± 7.84 years; 516 male) enrolled. Of 131 patients (17.96%), 96 presented with a TIA, 23 with a minor stroke, and 12 with a major stroke. Mean carotid stenosis was 80.13% ± 8.51% (median, 80%; range, 50%-99%). An embolic protection device was employed in 727 patients: distal filter in 589 (80.79%) and proximal occlusion in 138 (18.93%). Technical success was achieved in all but two patients (99.86%), whereas procedural success was 100%. At 24 hours from the procedure, one patient died of a hemorrhagic stroke; two minor strokes and six TIAs were also noted. One patient suffered a nonfatal AMI; ECA occlusion was evident in eight patients (1.09%). To June 2019, 529 patients completed 1-month follow-up. Three new neurologic adverse events were recorded (one minor stroke, two TIAs). One patient suffered an AMI in the absence of a fatal event; ECA patency was 97.6%. Data from 253 patients with 1-year follow-up showed no further neurologic events, whereas 7 deaths were reported (2 fatal AMIs, 4 neoplasms, and 1 suicide). ECA patency was 95.65%.

5 мар. 2021 г.

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