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.
Idorsia Ltd. looks on course to produce another marketed drug after supportive phase III results for its hypertension drug, aprocitentan. The company’s first U.S. FDA-approved drug, Quviviq (daridorexant), was launched in April and another product, Pivlaz (clazosentan), was approved and launched in April for cerebral vasospasm in Japan.
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.
Keros Therapeutics Inc. announced preliminary results from a phase I trial of its engineered ligand trap KER-012 that gave its team confidence to proceed with larger studies in pulmonary arterial hypertension (PAH) and potentially some bone diseases. But company shares (NASDAQ:KROS) fell 16.6% to $38.50 May 18, following the announcement, perhaps over concerns about trial subjects that emerged in a company-hosted investor call.
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.
Abbott Laboratories reported results from its PERSIST-END study demonstrating that close to nine in 10 patients treated for persistent atrial fibrillation (AF) with its Tacticath contact force ablation, sensor-enabled (Tacticath SE) were free of symptoms of their arrhythmia over 15 months of follow-up. The study’s findings, which supported a November 2021 FDA approval for persistent AF, also showed significant improvement in patients’ quality of life and a more than 50% cut in the use of health care resources, the company said.
RSS
