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TEL AVIV, Israel, 3 September 2020 (GLOBE NEWSWIRE) – InspireMD, Inc.(NYSE American: NSPR), the developer of the CGuard ™ Onslical Prevention System (EPS) for the prevention of strokes caused by carotid artery disease (CAD), today announced the award for best poster in the ESC Congress for presenting updated knowledge of the giant paradigm-EXTEND long-term review of the CGuard ™ (EPS) onslical prevention system, as a component of the European Society of Cardiology’s 2020 carotid update, electronic filing to the Society’s 2020 Congress Cardiology (ESC).PARADIGM / EXTEND is an ongoing test led by a researcher with the carotid stent CGuard for the number one and secondary prevention of stroke in a giant population with a consecutive follow-up of 5 years (60 months).
Current effects of PARADIGM-EXTEND were presented for 480 patients out of an expected total of 550 patients who completed 30-day follow-up.There were no primary peri-procedure strokes or deaths.days 1.04% (5/480) due to two minor strokes, a myocardial infarction and two stent-free deaths In the study, 354/480 patients completed 12-month follow-up with only 1 patient with remaining intra-stent, 0.28% (1/354). During the 12-month follow-up, no other adverse clinical occasions similar to the device were reported.Finally, 46/480 patients ended the 60-month follow-up era with some other case of intra- the stent remains and there are no other cases of stroke similar to the device.
The principal investigator of the study and presenter at the ESC Congress, Professor Piotr Musialek, from the Department of Heart and Vascular Diseases at John Paul II Hospital at Jagellonne University, Krakow, Poland.Professor Musialek said: “In patients following all arrivals, CGuard EPS stent has almost abolished, on an unprecedented scale, the threat of remaining carotid-related stroke. Based on PARADIGM-EXTEND and other accumulated clinical knowledge on the protection and efficacy of CGuard, in our ESC 2020 carotid update, we report that the increase in the use of the stent covered through MicroNet demonstrates a basic replacement in the carotid revascularization paradigm, with particularly greater proportions of patients who can now gain advantages from this generation and percutaneous intervention.
“The effects of this research-led initiative and the popularity resulting from the most productive poster continue to demonstrate that CGuard provides greater protection and effectiveness in stroke prevention when added to optimized medical therapy.We continue to prioritize patient care by focusing on measuring evidence confirming the superiority of CGuard EPS in the prevention of neurovascular diseases.Recognition of this knowledge through such constructions of popularity accepts as true and awareness within the medical community.Our global expansion strategy and our goal of bringing CGuard to the US are not the only one in the world.UU.se is based on delighting in and effects. We believe that the new MicroNet technology, which is at the heart of the CGuard system, provides a transparent differentiator in terms of preventing more ischemic occasions and staying,” said Marvin Slosman, CEO of InspireTM.”We are grateful to Professor Musialek and Jagiellonian for their paintings on the PARADIGM-EXTEND exam, and look forward to sharing the effects of this exam and other key milestones as we continue to monitor patient outcomes.”
The ESC 2020 Congress is digitally positioned from August 29 to September 2, 2020 and is available https://www.escardio.org/Congresses
The PARADIGM-EXTEND test was designed to evaluate the long-term clinical efficacy and protection of CGuard use in 550 patients after carotid revascularization.The examination is a full examination, followed by all referrals, without any exclusion criterion other than lack of indication.In our minds through the neurovascular team, clinically asymptomatic patients had to obtain revascularization only by characteristics of higher risk of stroke, adverse occasions are independently evaluated, to date 480 patients (39-87 years, 60% symptomatic, 142 women) with 514 arteries have passed the first follow-up window of 30 days.
At the height of the CGuard® EPS The CGuard® embolic protection system is a complex platform solution designed to offer the flexibility of the classic open mobile stent with complex coverage against perioperative and post-operative embolic occasions procedure caused by plaque prolapse through the strength of the stent leg that can cause a stroke Guard’s exclusive MicroNet generation® mitigates prolapse and related embolization and has shown clinical results amazing for patients compared to the types of carotid stent of choice, classic or next-generation double-layer stents and invasive procedures such as endarterectomy, a primary surgical procedure.Inspire’s CGuard ™ has created a new size in the protected remedy of carotid artery disease with the possibility of identifying a new popular treatment for the control of carotid artery diseases and the prevention of strokes.
InspiredTM, Inc.InspireTM seeks to use its patented MicroNet® generation to make its products the carotid stents industry by delivering exceptional acute effects and long-term non-stroke effects.
Non-unusual InspireTM inventories are indexed in NYSE American under the NSPR inventory symbol, and some warrants are indexed in NYSE under the NSPR inventory symbol.WS and NSPR.Wsb.
Forward-looking statements
This press release includes “forward-looking statements.” These statements would possibly be preceded by the words “intends”, “possibly”, “will”, “plans”, “expects”, “anticipates”, “plans”, “predicts”, “estimates”, “objectives”, “believes “,” wait “,” potential “or similar words. Forward-looking statements are not promises of long-term functionality, they are based on safe assumptions and are subject to various known and unknown threats and insecurities, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, therefore, the actual effects may differ materially from those expressed or implied by such forward-looking statements. These threats and insecurities include, but are not limited to, threats and insecurities related to (i) market acceptance of our new and existing products, (ii) negative effects of clinical trials or long product delays . in key markets, (iii) the inability to download regulatory approvals for the sale of our products, (iv) the effect of the COVID-19 pandemic on our production, sales, business plan and global economy; (v) intense festival in the medical device industry by much larger multinational companies, (vi) product liability claims, (vii) product malfunction, (viii) our limited production functions and use of contractors to support, (ix) inadequate or inappropriate reimbursement through government and other third party payers of our products, (x) our efforts to offload and maintain successful high-level asset coverage covering our products, which would not possibly be a success , (xi) legislative or regulatory reform of the health care formula in the United States and foreign jurisdictions, (xii) our reliance on unmarried suppliers for certain components of the product, (xiii) the fact that we will want to raise more capital to satisfy our long-term business desires and that such a capital increase is likely to be costly, dilutive, or complicated to offload and (x iv) the fact that we operate in multiple foreign jurisdictions, exposing ourselves to fluctuations in exchange rates, logistics and communication. ons challenges, burdens and prices of compliance with foreign legislation and political and economic instability in each jurisdiction. The most detailed data about the company and the points of threat that could possibly be the functionality of the forward-looking statements are set out in the company’s filings with the Securities and Exchange Commission (SEC), adding the company’s annual report in the Form 10-K and its quarterly report. . Reports on Form 10-Q. Investors and collateral holders are encouraged to read the individual documents on the SEC’s online page at http://www.sec.gov. The Company assumes no legal responsibility to publicly update or revise its forward-looking statements as a result of new data, long-term occasions, or otherwise.
Investor Contacts: Craig Shore, CFO, InspireMD, [email protected]