Successful live case transmission again demonstrated CGuard’s™ differentiated patient protection features and ease of use
TEL AVIV, Israel, June 09, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke, today provided the following highlights from multiple presentations and live case transmission, all featuring its CGuard™ Embolic Prevention Stent System, from LINC 2022, which was held June 6-9.
“Our participation and presentations at this years’ LINC conference allowed us to demonstrate the compelling features of the CGuard™ Embolic Prevention Stent System that we believe are building a new standard of care in carotid revascularization,” said Marvin Slosman, chief executive officer of InspireMD. “Of particular note, CGuard™ was featured in a very successful live case that clearly demonstrated the advantages of optimal vessel conformability with sustainable MicroNet mesh protection for best patient outcomes. LINC remains an important medical congress, and our growing presence year after year is a clear reflection of our progress and growing market leadership in carotid stenting and stroke prevention”
Highlights of this year’s LINC presentations include:
Title: CGuard Live case transmission from Heart Center, Leipzig, Germany
Operators: Dr Andrej Schmidt and Dr Andreas Fischer
The live case was conducted by Dr. Andrej Schmidt and Dr. Andreas Fischer, interventional Angiologists at University Hospital, Leipzig, Germany. The patient was a 62 year old asymptomatic male with progressive and calcified internal carotid critical stenosis. The procedure was successfully performed with the 10mm x 30mm CGuard™ EPS, obtaining an excellent angiographic result.
Following the procedure, Dr. Schmidt commented, “The CGuard EPS stent has superb conformability with its open cell design and having the MIcroNet mesh technology gives my patient the greatest protection available in carotid stenting.”
Title: Randomized Controlled Trial of a First-Generation Carotid Stent vs. the MicroNet-Covered Stent: 12-Month Outcomes
Presenter: Savr Bugurov
This presentation highlighted key secondary endpoint data from the Randomized Control Trial comparing the MicroNetTM covered stent (CGuard) versus first generation open cell Abbott’s Acculink™ stent.
Key highlights include:
The cumulative incidence of death, stroke or myocardial infarction (DSMI) at 1 year for Abbott Acculink N=5 (10%) versus InspireMD’s CGuard N=1 (2%).
The incidence of restenosis or vessel occlusion at 1 year for Abbott’s Acculink N=4 (8%) versus InspireMD N=0 (0%).
Conclusion: In the randomized controlled study, 12-month outcomes showed in the Acculink™ stent a higher prevalence of death, stroke, MI (DSMI), restenosis / vessel occlusion, when compared with the CGuard MicroNet protected stent arm.
Title: MicroNet™-Covered Stent in Stroke Prevention and Treatment: New Evidence
Presenter: Piotr Musialek
PARADIGM-500 includes 500 patients enrollment with 533 procedures performed; the largest all-comer single-center registry of neuroprotected CGuard carotid artery stenting procedures.
Peri-procedural events (within 48 hours of procedure) were 3 events (2 minor strokes and 1 MI, no death or major stroke (N=3 (0.56%)).
At 30 days there were no strokes, but 2 deaths resulting in a cumulative total 30-day DSMI rate of N=5 (0.94%)
At 12 months no major ipsilateral stroke
At 12 months in stent restenosis/target lesion revascularization (duplex ultrasound follow up) of N=2 (0.41%)
Piotr Musialek concluded by stating, “Competent carotid artery stenting, with a tailored use of the access route (transfemoral, transradial, transcarotid), tailored use of a proximal/distal embolic protection device, and a 100% embolic prevention stent use shows unprecedented safety and efficacy in asymptomatic and increased-stroke-risk asymptomatic patients.”
Title: Stent properties and vessel adaptability: could these factors influence procedural outcomes?1
Presenter: Matteo Stefanini
CGuard was the only stent which maintained the original vessel morphology while the compared stents, Wallstent and Roadsaver significantly altered the vessel shapes.
The investigator concluded that CGuard optimizes conformability compared to Wallstent and RoadSaver stents.
About LINC LINC, the LEIPZIG INTERVENTIONAL COURSE is strongly committed to contribute to a systematic scientific evaluation and interdisciplinary discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the “vascular patients” by integrating colleagues of different specialties from around the world who are performing endovascular interventions.
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 Nasdaq under the ticker symbol NSPR.
We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts:
Craig Shore Chief Financial Officer InspireMD, Inc. 888-776-6804 craigs@inspiremd.com
Chuck Padala, Managing Director LifeSci Advisors 646-627-8390 chuck@lifesciadvisors.com investor-relations@inspiremd.com
