InspireMD, Inc. (OTC BB: NSPR) ("Inspire" or the "Company"), the developer of the MGuard™ mesh protective stent system, today announced another positive study, reinforcing MGuard's position in the cardiology market.
In a preliminary evaluation by Drs. Dmitry Dratva, Yaron Almagor, Jonathan Balkin, David Rosenmann, Mark Klutstein, Dan Tzivoni and David Meerkin from the Department of Cardiology at Shaare Zedek Medical Center, Jerusalem, Israel, the MGuard stent demonstrated excellent performance in a highly complex lesion subset with limited angiographic and procedural complications, suggesting its effectiveness in minimizing the possible embolic shower during stenting procedure, potentially replacing thrombus aspiration and distal protection devices in selected cases. The results of the analysis were presented at the EuroPCR 2011, the official congress of the European Association of Percutaneous Cardiovascular Interventions, held this month in Paris, France.
Distal embolization with no reflow/slow flow remains the principal complication of stent deployment in patients during heart attack and in other thrombus-containing lesions and degenerative vein grafts. This market segment contributes about one-third of the total stenting procedures completed. Other solutions in the study did not demonstrate any advantages in helping patients from distal embolization. While distal protection has demonstrated benefits only in vein grafts, and has no value in native vessels, the MGuard showed a benefit for multiple thrombus-containing lesions in the study, including in the treatment of patients during heart attacks. A commercially available mesh covered stent (MGuard) was used as an in situ protection device.
Dr. Asher Holzer, co-founder and President of InspireMD commented, "This study further demonstrates the efficacy of the MGuard mesh protective stent system, currently utilized in more than 500 hospitals worldwide, especially in thrombus loaded lesions . This analysis represents another positive data point, added to other studies which show the advantages of MGuard. This evaluation reinforces our confidence as we continue the MASTER (MGUARD for Acute ST Elevation Reperfusion) Randomized Trial, a multinational randomized controlled trial designed to demonstrate MGuard Coronary Stent's advantages over standard care for STEMI (heart attack) patients, chaired by Dr. Gregg Stone from Columbia University."
Conclusions reached in this preliminary evaluation were that the MGuard stent demonstrated effective performance in a highly complex lesion subset, with limited angiographic and procedural complications, suggesting its effectiveness for these indications.
"This analysis of our initial experience with MGuard confirms our expectations of its performance in cases with a high risk for distal embolization," stated Dr. David Meerkin, Director of Experimental Cardiology, Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel. "The added value of the MGuard Micro-Mesh for this subset of patients appears to provide a substantially better procedural outcome. This leaves us with high expectations that the MASTER trial will confirm the benefits of MGuard for thrombus laden lesions in a randomized fashion."
"Shaare Zedek Medical Center in Jerusalem was one of the early adopters and is one of the leading centers in MGuard usage worldwide," added Ofir Paz, co-founder and CEO of InspireMD. "Their confidence in the benefit of the MGuard Micro-Mesh technology for thrombus management has been unfailing from the beginning. The acceptance of this analysis for presentation at EuroPCR this month was gratifying for us all and serves as yet another indication of the potential of our technology. We are repeatedly learning of additional centers worldwide revealing their analysis of collective MGuard data showing improved outcomes similar to these in the treatment of patients with highly complex thrombotic lesions."
Details and methodology:
* The MGuard stent was used at operator discretion for cases considered at risk for significant distal embolization.
* Data was prospectively collected in a registry for all cases where the MGuard stent was used including patient, lesion and procedural characteristics, as well as procedural and in hospital outcomes.
* The results of a total of 82 patients (68 males) were included in this analysis with a mean age of 61 +/-14 years.
* In all but one case the MGuard stents were successfully deployed.
* These included 41 STEMIs, 18 SVGs, with the remaining patients having an angiographic appearance of a thrombus laden lesion in a native coronary artery.
o Of these, 9 presented with stable angina.
* In the 63 stents in native coronaries, there were 2-LM, 28-LAD, 6-Cx and 27-RCA.
* 2B3A inhibitors were used in only 20 cases (25%) and aspiration performed in 25 cases (31%). Predilation was performed in 63 cases.
* Failed passage of the stent occurred in a single case to mid RCA lesion, where it was removed and the procedure completed successfully.
* No reflow occurred in 2 cases (2.5%) one of which occurred prior to stent deployment.
* In an additional case there was asymptomatic loss of a side branch.
* Perforation of a vein graft occurred in a single case following stent deployment. This was effectively treated with deployment of an additional MGuard stent.
About MGuard™ Coronary
MGuard™ is a combination of a coronary stent merged with an embolic protection specifically designed for Acute MI patients. The embolic protection is comprised of an ultra-thin polymer mesh sleeve that wraps the stent. The MGuard™ coronary seeks to provide permanent embolic protection, without affecting deliverability. MGuard™ is CE Mark approved. Mesh-based protection is now recommended for use in the recent Guidelines of the Task force of Myocardial Revascularization of the European Society of Cardiology (ESC).
About InspireMD Inc.
InspireMD is an innovative medical device company focusing on the development and commercialization of its proprietary stent system technology, MGuard™. InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures. InspireMD's common stock is listed on the OTC BB under the ticker symbol "NSPR".
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" 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, multi-national companies, (v) product liability claims, (vi) our limited manufacturing capabilities and reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (viii) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (ix) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (x) our reliance on single suppliers for certain product components, (xi) 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 (xi) 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, including the Company's Current Report on Form 8-K filed with the SEC on April 6, 2011. Investors and security holders are urged to read these documents free of charge on the SEC's web site at 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.
OTC BB: NSPR
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SOURCE InspireMD, Inc.