InspireMD, Inc. 8K

InspireMD reported favorable 30-day CGUARDIANS II trial results for its CGuard Prime 80 cm stent for TCAR and highlighted an FDA PMA supplement under review that could expand its U.S. market opportunity if approved in H2 2026.

InspireMD, Inc. announced 30-day results from its CGUARDIANS II clinical trial evaluating the CGuard Prime 80 cm carotid stent implant for use in transcarotid artery revascularization (TCAR) procedures, reporting 100% acute device success across 50 patients, no deaths, strokes, myocardial infarctions or stent thrombosis, and complete stent patency in evaluable subjects at 30 days, and noted that a Premarket Approval (PMA) supplement for this 80 cm system is under FDA review with anticipated U.S. approval in the second half of 2026, which could expand its addressable market into the TCAR segment in addition to carotid artery stenting (CAS).

Filing Facts

CIK

1433607

Ticker

-

Form

8K

Source Type

sec

Accession

0001493152-26-028221

Alert Tier

6