Healthcare Industry News: embolic protection
News Release - May 22, 2007
InspireMD Announces Enrollment of 19 Patients in its First in Man Study
InspireMD MGuard(TM) Coronary Stent Demonstrates Promising Preliminary ResultsTEL AVIV, Israel--(HSMN NewsFeed)--InspireMD announced today the enrollment of 19 patients in its First in Man study in a multi center registry of percutaneous coronary intervention performed with the MGuard(TM) Coronary stent at the Heart Center in Siegburg, Germany.
MGuard(TM) Coronary Stent is designed to provide embolic shower protection during and post procedure. It is under investigation to treat patients with Coronary and SVG Disease.
Interim results have shown a procedural success rate of 100% and no report of any major adverse cardiac events. To date, the First in Man MGuard (TM) Coronary Trial has shown safety in human coronary and vein graft indications.
"Our cardiologists reported that the stent was easily and seamlessly deployed and performed very well without complications," said Prof. Eberhard Grube, Chief of the Department of Cardiology/Angiology at the Heart Center in Siegburg, Germany." The patients are feeling well and we are confident that they will continue to do well." Prof. Grube is one of the world's leading interventional cardiologist and is heading the trial: "The deliverability and procedure with the MGuard stent is identical to any conventional stent. Based on the animal study and the interim results in patients, we are confident that the stent is safe and effective."
"This is a very exciting time for us at InspireMD," said Ofir Paz, InspireMD CEO. "We have reached a significant milestone in the clinical development of the MGuard(TM) Coronary stent. The encouraging results validate our product concept and pave our way to becoming a key player in the stent market."
About MGuard(TM) Coronary
MGuard(TM) Coronary is designed to provide protection from embolic showers, during and post procedure. Embolic shower is the dislodgement into the blood flow of the clotting material called emboli, an adverse result of the stent's impact on the arterial wall. The embolic shower may happen during the procedure or sometime after it has ended and may cause thrombosis and stroke. In fact, the threat of stroke is the main deterrent of using stenting for treatment of clogged carotids.
MGuard(TM) Coronary presents a novel combination of a coronary stent merged with embolic protection device. An expandable, fishnet style, micron level knit sleeve wraps the stent, preventing plaque detaching during and post procedure. As the protection device is an integral part of the stent, MGuard does not add any complexity in deliverability, and provides inherent long acting emboli protection. The sleeve also diffuses stent pressure, thereby reducing injury to the vessel wall and lowering restenosis. MGuard's innovative concept has enjoyed an enthusiastic welcome from world leader intervention cardiologists. CE mark is pending and expected around the end of June 2007.
"Embolic shower is a prevailing problem in coronary stenting, and carries even a higher risk in carotids stenting," says Prof. Grube. "The concept of the MGuard stent provides a comprehensive solution during and post procedure."
About InspireMD
InspireMD Ltd. is an innovative developer of next generation coronary and carotid stents. Its solutions are designed to benefit patients by enabling more effective procedures with a lower side effect profile, while limiting the need for additional protective devices.
In addition to providing continuous embolic protection and minimize arterial injury, this promising technology is aimed to provide an effective and uniform drug delivery system for drug eluting stents. InspireMD intends to pursuit applications of this technology both for bare metal and drug eluting stents in coronary, SVG, carotid, renal and periphery stenting.
For more information about the Company and its products go to www.inspire-md.com.
Visit us at PCR-07 May 22-25, 2007 in Barcelona, Spain - Booth # K6
Source: InspireMD
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