Elixir Medical announced positive data demonstrating the benefit of its DynamX coronary bioadaptor system in target lesion failure (TLF). Data highlighted the success of DynamX compared to Medtronic's Resolute Onyx zotarolimus drug-eluting stent (DES). The study looked at complex patient populations within the INFINITY-SWEDEHEART randomized … [Read more...] about Elixir Medical has positive data for drug-eluting bioadaptive implant
Stents
Peytant wins FDA de novo nod for covered stent system
Peytant Solutions announced today that the FDA granted marketing authorization for its AMStent tracheobronchial covered stent system. Plymouth, Minnesota-based Peytant designed its AMStent to treat pulmonary obstructions caused by cancer. The novel, proprietary therapy platform is indicated for treating tracheobronchial strictures produced by … [Read more...] about Peytant wins FDA de novo nod for covered stent system
Medinol has first human implant of drug-eluting peripheral stent in Australia
Medinol today announced the successful first-in-human implantation of its ChampioNIR drug-eluting peripheral stent. Dr. Gerard S. Goh and Dr. Thodur Vasudevan of the Alfred Hospital in Melbourne, Australia, completed the stent implant. The company says it introduces a "revolutionary advancement" in the mechanics, durability and drug delivery of … [Read more...] about Medinol has first human implant of drug-eluting peripheral stent in Australia
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
Edwards launches Sapien 3 valve with Alterra prestent in Europe
Edwards Lifesciences (NYSE:EW) announced that it launched its Sapien 3 transcatheter pulmonary valve implant (TPVI) system with Alterra adaptive prestent in Europe. The launch expands the continent’s minimally invasive treatment options to a broader range of patients with congenital heart conditions. Edwards recently received CE mark for … [Read more...] about Edwards launches Sapien 3 valve with Alterra prestent in Europe
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
Renata Medical announces first growth stent implant following FDA approval
Renata Medical announced the first completed implantation of its Minima growth stent for young children after winning FDA approval. Newport Beach, California-based Renata picked up FDA approval for the first-of-its-kind stent last week. The company designed the stent to re-expand over the course of the child’s growth period. “Today marks the … [Read more...] about Renata Medical announces first growth stent implant following FDA approval
Renata Medical wins FDA nod for first-of-its-kind stent for young children
Renata Medical today said the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children. Newport Beach, California-based Renata designed the stent to re-expand over the course of the child’s growth period. The company says its approval marks a “groundbreaking advancement” in care for young children … [Read more...] about Renata Medical wins FDA nod for first-of-its-kind stent for young children
Reflow Medical enrolls first patient in coronary sirolimus-eluting retrievable scaffold system study
Reflow Medical announced that investigators enrolled the first patients in a trial of its Spur sirolimus-eluting retrievable scaffold system. DEEPER CORONARY evaluates the Spur Elute stent as a primary treatment for in-stent restenosis (ISR) of the coronary arteries. Spur Elute offers a treatment by transferring a proprietary drug formulation to … [Read more...] about Reflow Medical enrolls first patient in coronary sirolimus-eluting retrievable scaffold system study
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
