Perfuze announced today that it completed enrollment in its U.S. FDA investigational exemption (IDE) trial evaluating its stroke treatment. Galway, Ireland-based Perfuze also announced a new personnel appointment, naming Joe Rotger EVP of sales. According to a news release, Perfuze completed enrollment in the MARRS (millipede aspiration for … [Read more...] about Perfuze completes enrollment in stroke catheter study, appoints VP of sales
Neurology
Terumo Neuro wins FDA nod for first dual-layer carotid stent
Terumo Neuro (formerly MicroVention) announced today that it received FDA premarket approval (PMA) for its Carotid Stent System. Aliso Viejo, California-based Terumo Neuro says this marks the first dual-layer micromesh carotid stent approved in the U.S. It offers physicians a clinically proven option to improve patient outcomes in carotid artery … [Read more...] about Terumo Neuro wins FDA nod for first dual-layer carotid stent
Imperative Care to kick off new trial of Zoom stroke treatment
Imperative Care announced today that it intends to fund a trial comparing its Zoom stroke system plus best medical treatment to treatment alone. Campbell, California–based Imperative Care designed Zoom for fast and effective clot removal from access through reperfusion. It treats patients with acute ischemic stroke, enabling smooth tracking … [Read more...] about Imperative Care to kick off new trial of Zoom stroke treatment
Anaconda Biomed enrolls first patient in study of funnel catheter for treating stroke
Anaconda Biomed announced the enrollment and treatment of the first U.S. patient in a clinical trial of its ANA Funnel Catheter. Dr. Shahram Majidi performed the first treatment in the ATHENA trial at Mount Sinai in New York. The 327-patient study evaluates the safety and effectiveness of the proprietary funnel catheter. Anaconda designed the … [Read more...] about Anaconda Biomed enrolls first patient in study of funnel catheter for treating stroke
Medtronic recalls embolization device after reported deaths
The FDA deemed a recall of some Medtronic Pipeline Vantage embolization devices serious after multiple deaths related to the device. The recall involves removing Pipeline Vantage 027 device models from use and sale and updating instructions for Pipeline Vantage 021 models. Medtronic's Pipeline Vantage embolization devices with Shield Technology … [Read more...] about Medtronic recalls embolization device after reported deaths
Perfuze wins FDA nod for access catheter, raises $24M
Perfuze announced today that it received FDA 510(k) clearance for its Zipline access catheter and secured significant funding. The Galway, Ireland–based medtech company picked up about $24 million (€22 million) in a follow-on funding round. Existing investors, including Earlybird, EQT Life Sciences, Seroba and SV Health, participated in the … [Read more...] about Perfuze wins FDA nod for access catheter, raises $24M
Lungpacer wins FDA IDE for AeroNova system
Lungpacer Medical announced today that it received FDA investigational device exemption (IDE) to begin a trial for its AeroNova system. The STARI (stimulation to activate respiration) trial evaluates the feasibility of the investigational AeroNova system. It looks at the system in patients suffering from moderate to severe Acute Hypoxemic … [Read more...] about Lungpacer wins FDA IDE for AeroNova system
CereVasc randomizes first patient in head-to-head study of eShunt, standard of care
CereVasc today announced the first patient randomized to and treated with the eShunt system in its STRIDE clinical trial. STRIDE, a head-to-head comparison, pits the novel eShunt system against the standard of care ventriculo-peritoneal (VP) shunt in patients with normal pressure hydrocephalus (NPH). Investigators treated the first patient at … [Read more...] about CereVasc randomizes first patient in head-to-head study of eShunt, standard of care
Data backs Lungpacer Medical’s diaphragm neurostim
Lungpacer Medical today announced positive results from a Phase 1 clinical study evaluating its neurostimulation technology platform. The STIMULUS trial investigated the application of diaphragm neurostimulation to improve hemodynamic performance in patients on invasive mechanical ventilation. Results demonstrated improvement in hemodynamic … [Read more...] about Data backs Lungpacer Medical’s diaphragm neurostim
Johnson & Johnson MedTech launches catheter system for stroke
Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] announced today that it launched the CereGlide 92 catheter system for treating acute ischemic stroke. The launch comes just one day after media reports suggested that the company wants to sell its Cerenovus stroke business, the unit that makes the CereGlide … [Read more...] about Johnson & Johnson MedTech launches catheter system for stroke
