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Inspiring News September 2008

Inspiring News September 2008 Your quarterly update on InspireMD’s latest breakthroughs in PCI technology. Dear customer, Welcome to the first issue of the InspireMD newsletter.

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Inspiring News September 2008

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  1. Inspiring News September 2008 Your quarterly update on InspireMD’s latest breakthroughs in PCI technology Dear customer, Welcome to the first issue of the InspireMD newsletter. How can this newsletter help you with your challenges in transcatheter interventions? On a quarterly basis InspireMD will update you with the latest news as to how InspireMD contributes to meeting the challenges in transcatheter interventions. Current stenting practices are associated with several adverse consequences: plaque destabilization; embolic showers; restenosis, all of which may lead to cardiac complications and ultimately death. MGuard provides a solution to these unmet needs. • About InspireMD and its Flagship Product MGuard • InspireMD markets and develops pioneering products in the stent medical device category. • Its flagship product, MGuard™ - an innovative and unique stent, represents a significant breakthrough in stenting. • How does the MGuard™ work? • MGuard™ is based on a proprietary stent wrapped in a micron level net. • The net: • - Is a built-in permanent embolic protection device that captures embolic debris between the fiber net and the arterial wall. • Diffuses stent pressure and reduces injury to the vessel wall, thereby lowering the risk of restenosis. • MGuard™ has been endorsed by leading interventional cardiologists worldwide as a potential breakthrough technology designed to reduce Major Adverse Cardiac Events (MACE) by: • Blocking plaque detachment/embolic showers during and post PCI procedure • Reducing injury to the arterial wall • Reducing chances of restenosis • Deliverability and procedure with MGuard™ is similar when compared to any conventional stent. An Intriguing Case Report MGuard Use in ST Elevation MI with Total LAD Occlusion By Gregory Pavlides MD Onassis Cardiac Surgery Center, Greece. Figure 1 - Occluded LAD Figure 3 - Balloon and thrombus InspireMD will be exhibiting at : TCT 2008 in Washington, booth # 1141.  InspireMD Breakfast Meeting: Thursday 16 October, 7:00-8:00 am At TCT 2008, world leading interventional cardiologists will present the latest breakthrough data on the MGuard Coronary. More details will follow shortly Figure 2 - Wire passing Occlusion Figure 4 - Stent Deployment Final Result The procedure was terminated with optimal angiographic result and absence of any angiographic complications. Figure 5 - Final Result

  2. Inspiring News • On going trial – • 6 month follow up • The FIM trial is being conducted in 2 medical centers in Germany. The main objective is to evaluate the safety and efficacy of the MGuard stent in SVG and native coronaries. • Between October 2006 and February 2008, the 2 centers enrolled 41 patients and currently 32 of them have completed their 6 months follow-up period. • The results from the first 32 patients are: • 100% device success during the procedure • After 30 days only 1 patient (3%) had a cardiac event (non-ST elevation MI post procedure) • After 6 months restenosis at the target lesion occurred in 4 (12%) patients. • After 6 months mean late lumen loss is 0.39mm • We are continuing the follow-up and final report is expected in October 2008. MGuard - Acute MI Study in Poland InspireMD has initiated a pioneering pilot to evaluate the MGuard in acute STEMI patients by a prospective clinical study in Poland. The study received ethics committee approval and has started recruiting patients. The Study principal investigator is the leading Polish interventional cardiologist, Dr. Dariusz Dudek. In this trial, 60 patients with acute STEMI will receive the MGuard stent with no additional distal embolization or aspiration device. The primary endpoint is ST resolution and TIMI flow, and the follow up is up to 6 months Initial results will be available at TCT 2008 First Month Results – Safety and Efficacy Trial in Brazil A trial on the MGuard Coronary stent is being conducted in Brazil. The main objective of this study is to investigate the safety and efficacy of the MGuard stent in human subjects who are candidate for a PCI due to narrowing of a native coronary artery or a bypass graft. Currently only one center is enrolling patients. Since November 2007, 21 patients have been enrolled. The device demonstrated excellent performance in a highly complex lesion subset, with no angiographic and/or procedural complications and 0% clinical events at 30 days. Preliminary angiographic data has demonstrated high acute gain and minimal residual stenosis within the stented segment. 6 months angiographic follow-up has started and enrollment is ongoing.  An MGuard Testimonial By Dr Ricardo Costa Sao Paulo, Brazil “As we gained more confidence in the device and the performance of the device, we also used it in more native coronary vessels and large vessels with residual thrombus and patients with acute coronary syndromes. So far MGuard has been very successful in this wide spread of indications. We certainly feel much more comfortable in using MGuard” Dr Costa's experience in implanting 16 MGuard stents in the safety and efficacy trial in Brazil (see adjacent study report) CE Mark: MGuard Coronary Stent has CE Mark approval to treat patients with coronary artery diseases Not available for sale in the United States The information provided is only for use in countries with the necessary applicable health authority product registrations. MGuard Availability In order to obtain more information on how to order the MGuard Coronary Stent in your country, please contact: Tel: +49 302 5555155, e mail: info@inspire-md.com

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