Hemosonics LLC said it was recently awarded U.S. FDA clearance for a new hemostasis test cartridge assay it said significantly expands the indications for clinical use of its existing Quantra system to now also include trauma and liver transplantation procedures. The expanded Quantra hemostasis system with its QStat cartridge will add to capabilities of the system’s QPlus cartridge assay already established in the point-of-care and lab-based, whole blood hemostasis testing market.
Cerenovus Inc. reported primary results from the real-world EXCELLENT Registry showing positive outcomes with its Embotrap revascularization devices in the removal of stroke-inducing blood clots. Patients enrolled in the registry were treated with either the Embotrap II or Embotrap III devices as a first line therapy to treat ischemic stroke.
The University of Central Florida (UCF) and Orlando Health are testing new medical technology designed to identify blood clots more quickly in surgery. The monitoring device consists of a small optical fiber that uses red blood cells to track the process of blood coagulation in patients so doctors can watch for life threatening blood clot formation.
Penumbra Inc. presented new data at the LINC Symposium in Leipzig, Germany, evaluating its Indigo aspiration system for submassive pulmonary embolism (PE). The subgroup analysis evaluated performance outcomes of patients with main pulmonary artery (PA) emboli vs. discrete unilateral or bilateral PA emboli without main PA involvement. Data from the study suggests the system can be used effectively for both proximal and distal aspiration thrombectomy in the pulmonary arteries.
At the ongoing Biomed Israel 2022 event, Magneto Thrombectomy Solutions Ltd. has shared successful first-in-human (FIH) results showing safety and feasibility of its Etrieve system, a novel catheter based on electric fields for removing blood clots, in patients with acute pulmonary embolism (PE).
That excruciating moment when patients learn their lives are potentially at risk to a “wide neck” brain aneurysm could be softened by results of a long-awaited international study led by researchers at Massachusetts General Hospital (MGH) and Harvard Medical School. According to lead author Adam Dmytriw, wide-neck aneurysms will respond better to the Woven Endobridge Web device than metal stents and blood thinners.
Surmodics Inc. has acquired Vetex Medical Ltd., a Galway, Ireland-based company focused on venous clot removal, for $39.9 million. The move gives Surmodics a second FDA-cleared mechanical thrombectomy device, Revene, to treat venous vasculature, adding to its Pounce arterial thrombus retrieval system. Founded in 2016, privately held Vetex’s sole product is the Revene thrombectomy catheter. The device received FDA clearance in December 2020 and CE mark approval in May for the mechanical declotting and controlled and selected infusion of physician-specified fluids, including thrombolytics – clot-busting drugs – in the peripheral vasculature.
What started with Austrian regulators suspending use of one batch of Astrazeneca plc’s COVID-19 vaccine has expanded into precautionary holds in Denmark and other EU countries as PRAC, the EMA’s safety committee, investigates whether blood clots, which have resulted in at least two deaths in Europe, are connected to the vaccine.
