Aquedeon Medical reports the enrollment of the first patient in its IDE clinical trial for the Duett Vascular Graft System, used in open surgical aortic arch reconstruction. The Duett system aims to expedite vessel connection during surgery, potentially reducing the time patients are subjected to hypothermic circulatory arrest, thus lowering the risk of neurological complications.
Titan Medical and Conavi Medical have merged in an all-stock transaction to advance the commercialization of Conavi’s Novasight Hybrid System, which combines intravascular ultrasound and optical coherence tomography for guiding minimally invasive coronary procedures. The merger will enable the combined company to leverage Conavi’s innovative imaging technology and access public capital markets to fuel its growth strategy and expand the use of the Novasight Hybrid System globally.
Cerus Corporation announces positive topline results from its Phase III clinical trial of its blood purification system, showing a 2.5% rate of adverse events among participants. The trial focused on ensuring fewer or similar treatment-emergent adverse events compared to conventional red blood cell transfusions, positioning Cerus to apply for pre-market approval from the FDA next year.
Siemens Healthineers receives FDA clearance for its Ciartic Move mobile C-arm with self-driving capabilities, designed to accelerate and standardize 2D fluoroscopic and 3D CT imaging. The system aims to address intraoperative imaging challenges in various surgical specialties, offering automated workflows and reducing imaging time with its motorized features and wireless control.
Biotronik receives FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold (BTK RMS), designed to address chronic limb-threatening ischemia (CLTI). The device, featuring BIOmag magnesium alloy and Orsiro drug-eluting stent coating, aims to provide safety, improved deliverability, and vessel support during and after implantation, with a focus on optimizing outcomes for CLTI patients.
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