Inspiremd reports updated positive cguard™ eps data presented at veith 2019
Inspiremd, inc. reported on updated registry study data presented at the 2019 veith symposium, which was held november 19-23 in new york city. the data from long term investigator-initiated multi-center studies presented at veith continue to suggest that treatment of carotid artery stenosis with cguard™ eps results in lower rates of stroke and restenosis than other treatments presented, including first generation carotid stents, novel double carotid layer stents, and surgical or hybrid techniques. in particular, the company pleased to see the data presented from a greater than 700 patient, real-world, 20 center clinical study conducted by physicians of three major specialties including vascular surgeons, interventional cardiologist and interventional radiologists. this was complimented by a study that showed equally impressive results at 30 days and long-term follow-up out to four years. highlights: the paradigm-extend study enrolled 402 patients (436 arteries), all of whom were treated using cguard™ eps. peri-procedural outcome included one minor stroke and one type 2 myocardial infarction, yielding a neurological event rate of 0.5%. there were no deaths or major strokes; at 30 days follow-up, the neurological event rate was 0.5%, including one hemorrhagic transformation of prior ischemic cerebral infarct leading to death and one bleeding-related death; the 30-day accumulated neurological event rate was 1.0% (4/402); there were no reported post procedural ischemic strokes; patient follow-up data at 12, 24, 36 and 48 months suggest that cguard™ eps continues to maintain a favorable safety profile. conclusion: long-term patient follow-up out to 48 months show that cguard™ eps maintains a long-term clinical benefit.
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