Medtronic plc has scored a CE mark for its Affera mapping and ablation system for atrial arrhythmias, mere months after acquiring the technology from cardiac solutions company Affera Inc. The dual-use system, which includes the Sphere-9 catheter and Affera Prism-1 mapping software, will be available in Europe beginning in the first half of 2023.
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.
Andera Partners and Novo Holdings A/S led a financing round which raised $25 million for Fire1 Ltd. and will accelerate the development of the company’s remote monitoring technology that improves outcomes for heart failure patients. Andera and Novo are new investors in Fire1 and were joined in the fundraising round by existing investors Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic plc, New Enterprise Associates and Seventure Partners.
Acesion Pharma ApS reported that its lead drug candidate AP-30663 hit the primary endpoint of a phase II trial in atrial fibrillation (AF). The study had an adaptive design, which allowed for the recruitment of up to 108 patients experiencing an active AF episode, but the study investigators saw sufficient efficacy after a blinded evaluation of just 63 patients to terminate at that point. The study, which began shortly before the COVD-19 pandemic, had been underway for three years at that stage.
Homozygous familial hypercholesterolemia (HoFH) is a severe rare life-threatening condition where high blood levels (>500 mg/dL) of low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and premature and progressive atherosclerotic cardiovascular disease (ASCVD) are the main features.
Johnson & Johnson’s Biosense Webster division reported that its Qdot Micro diagnostic and ablation deflectable tip catheter secured approval for marketing in China from the National Medical Products Administration where options for treating arrhythmias are seeing growing demand. A radiofrequency (RF) ablation catheter, Qdot Micro reduced total ablation procedure time by nearly 90 minutes.
Methinks Software SL (dba Methinks.AI), a digital health company, is working on the U.S. FDA submission for its artificial intelligence (AI)-based stroke triage software, which will aid in the detection of acute stroke, after recently receiving CE mark certification.
Current antithrombotic therapies for the prevention and management of cardiovascular disorders such as thrombosis, myocardial infarction (MI) or stroke present an associated risk of bleeding. The essential events leading to the formation of hemostatic clots are platelet activation and fibrin formation. When activated, the prostacyclin (IP) receptor prevents platelet aggregation in arteries and veins after injury.
RSS
