As a result of this change, MASTER II will no longer be an FDA registration trial. This decision will allow the Company to direct more resources to the DES program and commercial activities for the MGuard and CGuard. This includes the decision not to resume enrollment in the MASTER II trial for the primary endpoints of ST segment resolution and death and target vessel re MI. In light of current market conditions moving toward continued DES adoption and the delay in enrollment due to the FDA review process, the Company has decided to revise its MGuard strategy for the U.S. ![]() The initial technical feasibility testing phase (I) of DES candidates had a 100% success rate, enabling the program to progress on schedule with no additional work required prior to commencing the next phase of testing. As previously communicated, the Company expects to bring two viable (CE approved) DES products into an animal testing phase (II) which, if successful, is expected to lead to submission for CE registration of a DES MicoNet platform in the second half of 2015. The Company reported today that it has successfully entered the second phase of development work with the first Drug Eluting Stent (DES) candidate via strategic partnership. CGuard demonstrated 100% procedural success, 0% MACE at 30 days and a significant improvement in reducing new ischemic lesions as measured by diffusion weighted magnetic resonance imaging (dwMRI), as compared to historical controls. Positive CGuard first in man (FIM) data was reported last month in the CARENET trial presented at the Transcatheter Therapeutics Meeting (TCT) in Washington DC. The Company expects direct and distributor based selling to ramp up throughout the fourth quarter of 2014 and to be enhanced by the launch of the CGuard Carotid product. Further, all returned distributor inventory has been modified and the majority of its distributor partners have begun shipping product back into hospital accounts. The Company indicated that it believes all MGuard Prime inventory has been successfully modified and that it is back to full commercial activities in direct markets in Western Europe as of October 10th. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in stent Embolic Protection Systems (EPS), today provided commercial, development and clinical updates on the MGuard Prime coronary EPS product line and positioned the Company to address more efficiently its emerging MGuard and CGuard commercial opportunities. Investor conference call this morning at 8:30 a.m. MASTER II trial to suspend enrollment to support DES and Carotid Opportunities MGuard Prime commercial re-launch complete in direct markets Drug Eluting Stent (DES) program advances in development with partners SFDA urges all hospitals that have devices subjected to recall, to contact the company.InspireMD Resumes MGuard Prime Sales and Prioritizes DES and Carotid - New Product Programs This upgrade in the manufacturing process will improve stent retention and product performance.Īthorized Representative/Importer/Distributor: InspireMD intends to perform a manufacturing enhancement to all unexpired units of the MGuard Prime EPS systems. These complaints have not resulted in any patient injury. ![]() These complaints have primarily occurred during the preparation of the MGuard Prime EPS, upon removal of the protective sleeve,or during withdrawal of the MGuard Prime EPS into the guide catheter. Reason of Field Safety Corrective Action:įollowing recent complaints of MGuard Prime EPS dislodgements, InspireMDhas announced a Voluntary Field Safety CorrectiveAction. The diameter and length of each item is provided in the attached letter ![]() Implants, Non Active, Coronary Artery Stents. MGuard Prime Coronary Stent System Embolic Protective Stent (EPS)
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