Two research studies by Egnite Inc. presented at the American College of Cardiology Conference (ACC) could shake up the scope of how aortic stenosis (AS) is understood and treated by physicians.
Irvine Calif.-based Inari Medical Inc. reported results from what it described as the largest prospective study of interventional treatment in high-risk pulmonary embolism (PE), which found a 90% survival improvement in high-risk pulmonary embolism using the company’s Flowtriever System. Data from the FLAME (Flowtriever for Acute Massive Pulmonary Embolism) study in high-risk PE was presented at the 2023 American College of Cardiology (ACC) conference on March 5.
Aquapass Medical Ltd. has readied a pre-submission plan for the FDA this month to advance technology designed to reduce hypervolemia or fluid overload in patients suffering from heart failure, kidney failure or lymphedema. Conjuring up images of an astronaut stepping out onto a NASA loading dock, the Microclimate Suit uses low humidity and fast flowing air on the patient’s skin to evaporate excess bodily fluids. The suit won FDA breakthrough device designation in December 2022.
Ra Medical Systems Inc. launched a simple device that holds sutures more securely in place for closure of percutaneous wound sites during cardiac electrophysiology, structural heart and vascular surgical procedures.
Reflexion Medical Inc. has been granted U.S. FDA marketing clearance for biology-guided radiotherapy to treat early and late-stage cancers. An expansion of the company’s existing X1 platform, Scintix is indicated for patients with lung and bone tumors which may arise from primary cancers or from metastatic lesions spread from other cancers in the body.
Cardiorenal Systems Inc. has scored a U.S. FDA breakthrough device designation for technology to prevent patients undergoing cardiac surgery from developing acute kidney injury (AKI). AKI is reported in up to 30% of approximately 780,000 cardiac surgeries performed each year in the U.S., Europe and the Middle East, complicating patient recovery, prolonging ICU hospitalization and contributing to patient mortality after surgery.
Ottawa-based start-up Realize Medical Inc. reported U.S. FDA clearance of virtual reality (VR) surgical planning software to help physicians create and share complex patient anatomy from CTs and MRIs in an immersive 3D environment. Company CEO Justin Sutherland told BioWorld clearance of the Elucis platform “is a crucial milestone” that will benefit hospitals and his company well into the future.
The U.S. FDA has cleared a first-of-its-kind 4K single-use arthroscope developed by Pristine Surgical LLC to improve the efficiency, consistency, and safety of arthroscopic procedures. The single-use Summit surgical arthroscope is said to deliver a high-definition image using a simple set up and automated inventory management system for improved predictability and workflow.
Cardiovascular Systems Inc. (CSI) reported the submission by its partner Innova Vascular Inc. of U.S. FDA premarket notification for thrombectomy devices to treat peripheral vascular disease. Already an acknowledge leader in atherectomy technologies, St. Paul, Minn.-based CSI intends to acquire and commercialize each device to expand its technology portfolio to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
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.
