InspireMD (NSPR) Announces Presentation of Strong, 12-Month Follow-up Data for PARADIGM-101 of CGuard EPS at TCT 2016 Symposium
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InspireMD, Inc. (NYSE: NSPR) announced 12-month follow up data from PARADIGM-101 of the CGuard Embolic Prevention System (EPS) which were presented in two presentations at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium, taking place October 29 - November 2 in Washington, D.C. at the Walter E. Washington Convention Center.
In an oral presentation today in the Featured Clinical Research Session titled "Twelve-month Safety and Efficacy of CGuard™ Micronet-Covered Embolic Prevention Stent System: Routine Use to Perform Carotid Revascularization in Symptomatic and Increased Stroke Risk Asymptomatic Patients: The PARADIGM All-Comer Prospective Academic Study," Prof. Piotr Musialek, MD, DPhil, FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases, in Krakow, Poland, reported 12-month follow up data from PARADIGM-101. PARADIGM-101 is an investigator-led clinical study evaluating the use of CGuard™ EPS in 101 consecutive patients with carotid artery stenosis. Key findings from the presentation included:
- Zero device-related adverse events at 12 months
- CGuard™ EPS device and procedure success were each 99.1%. The device showed excellent placement precision, and there was no foreshortening or elongation
- Vessel narrowing was reduced from 83+/-9% to only 6.7+/-5% (p < 0.001) by independent core lab analysis
- Peri-procedural death/major stroke/myocardial infarction (MI) was 0%.
- One peri-procedural event was adjudicated by the Clinical Events Committee as a minor stroke (0.9%), with no change in NIH Stroke Scale or modified Ranking scale and no clinical sequel
- At 12 months the device showed a normal healing profile, and the patency of the external carotid artery was normal
"These data further reinforce the strong safety and efficacy profiles reported in previous trials of the CGuard™ EPS, and validate the system as an important option for endovascular management of patients with carotid artery disease," said Prof. Musialek. "Importantly, the very low incidence of peri- or post-procedural complications and stroke create a positive risk-benefit profile for CGuard™ EPS in patients with asymptomatic carotid artery disease. These patients are frequently denied intervention due to fear of the complications associated with conventional intervention, and are left with a substantial risk of stroke when treated only with medication. Our study found that CGuard™ EPS is applicable in up to 90% of all-comer patients with carotid stenosis. These data indicate that CGuard™ EPS may fundamentally alter the paradigm for managing patients with carotid artery disease, whether they have symptoms or not."
In addition, a poster titled "Highly Calcific Carotid Lesions Endovascular Revascularizaton Using a Novel Dual-layer Carotid Stent System CGuard™: Analysis from the PARADIGM Study," was presented by Adam Mazurek, MD, also from the Jagiellonian University Department of Cardiac & Vascular Diseases. Dr. Mazurek's study described the use of CGuard™ EPS to treat highly calcific carotid stenosis. Because patients with highly calcified carotid lesions are typically contraindicated for endovascular intervention due to suboptimal procedural outcomes with conventional stents, CGuard provides an important new treatment solution.
Key findings from Dr. Mazurek's presentation included:
- 16 of the 101 patients in PARADIGM-101 had hepatocellular carcinoma (HCC) lesions
- No difference in procedural success rates with CGuard™ EPS between highly calcified lesions and other lesions treated in this trial
- Use of CGuard™ EPS in management of highly calcified lesions was safe, with no neurologic or cardiac events during the procedure and during the stent healing period
- Highly calcified lesions treated with CGuard™ EPS showed no restenosis at 12 months
"Highly calcified lesions are particularly difficult to manage with conventional endovascular intervention due to the difficulty in achieving optimal procedure results on one hand, and the risk of carotid artery rupture or perforation on the other. Patients with these lesions remain at risk of stroke, and they require a safe treatment," said Dr. Mazurek. "The results of this study show that the design and mechanical properties of CGuard™ EPS enable safe and effective endovascular management and revascularization of highly calcified lesions. I believe CGuard™ EPS has significant potential as a new approach to managing these difficult lesions and reducing the risk of stroke in patients with highly calcified lesions. Additional studies of CGuard EPS™ in this patient population should further validate common use of this innovative embolic prevention stent system to improve the treatment and outcomes of carotid artery disease."
The data presented at TCT add to a growing body of clinical evidence validating the use of the CGuard as a proven treatment for both symptomatic and asymptomatic patients with carotid artery disease.
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