InspireMD today announced it received CE Mark approval for its CGuard Prime carotid stent system for the prevention of stroke. The Miami-based company said the next-generation carotid stent system was developed based on physician feedback and features improved deliverability and deployment. It builds on the original CGuard design, which uses a … [Read more...] about InspireMD wins CE Mark approval for CGuard Prime
InspireMD
InspireMD announces CFO retirement, transition
InspireMD announced today that Craig Shore, the company's CFO, decided to retire after the company identifies and appoints a successor. Shore intends to remain as CFO until the stroke prevention company names his replacement to assist in a smooth and orderly transition. He spent 15 years at InspireMD, helping to build the business into "a global … [Read more...] about InspireMD announces CFO retirement, transition
InspireMD wins FDA IDE for carotid stent study
InspireMD (Nasdaq:NSPR) announced today that the FDA granted investigational device exemption (IDE) for its CGuard Prime 80cm carotid stent system. The FDA says the company can begin the CGUARDIANS II pivotal study of the system used during transcarotid revascularization (TCAR) procedures. InspireMD picked Dr. Patrick Geraghty and Dr. Patrick … [Read more...] about InspireMD wins FDA IDE for carotid stent study
InspireMD submits carotid stent for FDA premarket approval
InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system. The company designed the CGuard Prime carotid stent system, made from nitinol, for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company's C-GUARDIANS … [Read more...] about InspireMD submits carotid stent for FDA premarket approval
InspireMD brings in $17.9M to support stent trial
InspireMD (Nasdaq:NSPR) announced today that it completed a full exercise of Series H warrants for proceeds of about $17.9 million. Tel Aviv, Israel-based InspireMD exercised 12.9 million warrants, converting primarily into pre-funded warrants. The gross proceeds for the company, which has a U.S. base in Westin, Florida, total $16.9 million … [Read more...] about InspireMD brings in $17.9M to support stent trial
InspireMD wins FDA approval for carotid stent system study
InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System. The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S. “This is a key milestone in the history of our company as it helps pave the way for … [Read more...] about InspireMD wins FDA approval for carotid stent system study
