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
Stents
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
MicroVention launches new stent in the U.S.
Terumo subsidiary MicroVention announced that it began the U.S. launch of its LVIS EVO intraluminal support device. The device is now available in the U.S. for the treatment of wide-neck intracranial aneurysms. Aliso Viejo, California-based MicroVention first launched the device in Europe in 2019, selling more than 12,000 units … [Read more...] about MicroVention launches new stent in the U.S.
Philips launches Duo venous stent system with FDA approval
Philips today announced the first implant of its Duo venous stent system following FDA premarket approval. Duo, an implantable medical device, treats symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI). Amsterdam-based Philips added Duo to its portfolio when it acquired Vesper Medical in 2021. On June … [Read more...] about Philips launches Duo venous stent system with FDA approval
Abbott wins FDA approval for dissolving drug-eluting scaffold
Abbott announced today that the FDA approved its Espirit everolimus-eluting resorbable scaffold system. The Espirit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. Abbott says that before … [Read more...] about Abbott wins FDA approval for dissolving drug-eluting scaffold
Cook Medical wins DOD contract for drug-eluting stents
Cook Medical announced today that the U.S. Dept. of Defense (DOD) awarded it an ECAT contract for implantable medical devices. The contract includes implantable vascular medical devices like the Zilver PTX drug-eluting peripheral stent. It also applies to the Zenith aortic endografts and associated interventional devices for treating vascular … [Read more...] about Cook Medical wins DOD contract for drug-eluting stents
Getinge wins European approval for covered stent system
Getinge announced today that it received EU MDR certification for its Advanta V12 covered stent system for patients with aortoiliac occlusive disease (AIOD). The balloon-expandable covered stent's indication aligns with AIOD, which includes treating lesions at the aortic bifurcation. Getinge said EU MDR certification highlights its dedication … [Read more...] about Getinge wins European approval for covered stent system
Getinge, Cook Medical sign U.S. commercial distribution agreement for iCast covered stent
Getinge and Cook Medical today announced they signed a commercial distribution agreement for the iCast covered stent system in the U.S. In this deal, Cook Medical will take over sales, marketing, and distribution rights for the product in the U.S. The iCast covered stent system will continue to be manufactured by Atrium Medical, a Getinge … [Read more...] about Getinge, Cook Medical sign U.S. commercial distribution agreement for iCast covered stent
