Shares in Acutus Medical Inc. (NASDAQ:AFIB) are trading 50% higher after the arrhythmia management company reported the launch of an expanded suite of its Acqcross left-heart access products. The Carlsbad, Calif.-based company received an expanded U.S. FDA clearance for its Acqcross Qx system for use with Natick, Mass.-based Boston Scientific Corp.’s Watchman left atrial appendage closure (LAAC) device.
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
The U.S. Centers for Medicare & Medicaid Services (CMS) had covered transcarotid artery revascularization for patients at high risk of poor outcomes during carotid artery endarterectomy to correct for stenosis, but the agency recently expanded that patient population to those at standard surgical risk. The news was lauded by the Society for Vascular Surgery (SVS) as a solid development for patients, given that this procedure’s complication rates are in many instances lower than seen in conventional endarterectomy.
Less than three years after unveiling the first Sonovein device, Theraclion SA is launching its CE-marked, third-generation platform, Sonovein HD. This represents a new generation of robotics platform for noninvasive treatment of varicose veins. The new version integrates the acquisition and analysis of technical data during the procedure.
Those who are burdened with Marfan syndrome face a lifetime of multi-organ system issues including potential aortic aneurysm, but help may be on the way in the U.K. The National Institute of Health and Care Excellence (NICE) has issued a recommendation that these patients be treated with personalized external aortic root support (PEARS) to treat both aortic root expansion and aortic dissection, although the agency indicated that this procedure is not quite ready for routine use in the National Health Service.
Endotronix Inc. reported positive data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella pulmonary artery pressure sensor system in New York Heart Association (NYHA) class III heart failure (HF) patients.
The transformation of cardiology continues with two U.S. FDA actions to promote the use of artificial intelligence (AI): a 510(k) clearance for Rapidai Inc.’s pulmonary embolism (PE) triage and notification product and breakthrough device designation for Anumana Inc.’s pulmonary hypertension (PH) early detection algorithm.
Following last week’s FDA approval of its Onyx Frontier drug eluting stent (DES), Medtronic plc released results at EuroPCR from a real-world, multicenter prospective study using its Resolute Onyx platform for percutaneous coronary interventions (PCI) in the left main artery. Rehovot, Israel-based Pi-Cardia Ltd. also released early data for patients treated with its Short Cut transcatheter device for coronary obstruction prevention.
The second generation of Boston Scientific Corp.’s Acurate Neo2 valve has demonstrated better performance than its predecessor, showing a threefold reduction of paravalvular leakage (PVL) said researchers. During the hotline/late-breaking trials session on May 17 at the EuroPCR meeting held in Paris, Andrea Buono, interventional cardiologist at Fondazione Poliambulanza Istituto Ospedaliero in Brescia, Italy, presented results from a large study comparing the performance of Acurate Neo and Acurate Neo2 in 13 Italian centers.
Medtronic plc has presented three-year data on its global, multicenter, blinded, randomized and sham-controlled renal denervation (RDN) clinical program Spyral HTN-ON MED during the late-breaking clinical trial session at EuroPCR on May 17. The trial enrolled 80 typical uncontrolled hypertensive patients, randomized to RDN or sham control.
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