Data from investigator-initiated multicenter, 729-patient IRONGUARD 2 study suggests that the use of CGuard™ EPS in routine clinical practice is associated with no major periprocedural, 30-day or one-year neurological complications
Tel Aviv, Israel — November 26, 2019 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, today reported on updated registry study data presented at the 2019 VEITH Symposium, which was held November 19-23 in New York City.
“The annual VEITH symposium is among the most prestigious gatherings of vascular surgeons, cardiologists, cardiac surgeons and vascular medicine specialists. We are pleased to once again see that the data presented at the symposium further demonstrates the clinical advantages of CGuard™ EPS,” said James Barry, Ph.D., chief executive officer. “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, we were 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.
“These data are driving a growing consensus among vascular specialists that CGuard™ EPS may be the safest treatment available today for the treatment of carotid artery disease. We continue to believe that CGuard™ EPS can redefine the treatment paradigm for patients with carotid artery disease, and we continue to work diligently to drive our growth plan forward and expand the availability of this novel technology,” concluded Dr. Barry.
Summary of the presentations are as follows:
Title: Preliminary Results from a Prospective Real World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention System: The IRONGUARD 2 Study
Presenter: Dr. Pasqualino Sirignano, Assistant Professor of Vascular Surgery, Department of Surgery “Paride Stefanini”, Vascular and Endovascular Surgery Unit, Policlinico Umberto, Sapienza University of Rome
Procedural success was achieved in 100% of patients
At 24 hours post-procedure, the complication rate was 0.73% (two minor strokes, six TIAs and one myocardial infarction)
Data from 529 patients at one-month follow-up showed a stroke complication rate of 0.54% (one minor stroke and one hemorrhagic). The accumulated neurologic event rate at 30 days was 1.63%
Data from 253 patients at one-year follow-up showed no further neurologic events
Conclusion: Data from this study suggests that the use of CGuard™ EPS in routine clinical practice is associated with no major periprocedural, 30-day or one-year neurological complications.
Title: Update on the C-Guard MicroNet Mesh Covered Stent for CAS: Longer Term Results: Advantages and Are There Late Downsides Like ISR or Late Thrombosis
Presenter: Dr. Piotr Musialek, Associate Professor of Cardiovascular Medicine, Jagiellonian University Department of Cardiac & Vascular Diseases, Krakow, Poland
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.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable stroke free long-term outcomes.
InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.
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