Stock-price weakness that has beset Chemocentryx Inc. since early March – likely based on jitters ahead of the FDA advisory panel for avacopan slated for May 6 – became an outright tumble when Wall Street got a gander at briefing documents related to the meeting. Shares of the San Carlos, Calif-based firm (NASDAQ:CCXI) closed at $22.19, down $26.63, or 45%, as company backers sifted paperwork on the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The compound has been assigned a PDUFA date of July 7.
The history of Medicare coverage of transcatheter aortic valve replacement (TAVR) devices has not lacked for controversy despite the massive positive impact on outcomes. Ashwin Nathan, of Hospital of the University of Pennsylvania, said a new analysis made clear that the expansion of centers qualified to perform TAVR procedures has been nearly all in high population density areas with an existing TAVR program, thus leaving out the still-forgotten rural patient.
Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S. The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF.
TORONTO – Opsens Inc. has inked an agreement with Madrid, Spain’s Cathmedical Cardiovascular SA to integrate its coronary physiology algorithms with the Spanish firm’s next generation hemodynamic system, notably Opsens’ diastolic pressure ratio (DPR) for measuring diastolic heart pressure.
The American College of Cardiology (ACC) hopes artificial intelligence (AI) can dramatically increase adoption of its frequently ignored guidelines for cardiovascular care. In three new studies, the ACC will implement Healthreveal's AI to recommend personalized interventions with the goal of preempting adverse cardiovascular events and improving patient outcomes, while increasing physicians’ adherence to guideline-directed medical therapy.
CMS has posted the draft Medicare inpatient rule for fiscal year 2022, replete with the usual controversies over reassignment of procedures under the Medicare diagnostic grouping system. One bit of good news is that the agency may carry over several expired new technology add-on payments (NTAPs) into the coming fiscal year, a move prompted by the difficulty of collecting claims data from fiscal year 2020 due to the COVID-19 pandemic.
Medtronic plc reported positive interim results on the first 171 patients implanted with Evolut transaortic valve replacement (TAVR) devices in its OPTIMIZE PRO clinical trial. The postmarket, prospective, multicenter study is assessing procedural outcomes, including pacemaker rate, associated with in-procedure techniques and post-procedure TAVR care pathways when using the self-expanding, supra-annular Evolut Pro and Pro+ TAVR systems in patients with symptomatic severe aortic stenosis.
Keeping you up to date on recent developments in cardiology, including: Fibroblast growth factor a marker for left ventricular hypertrophy in dialysis patients; Consortium updates endpoints for aortic valve studies; ‘Reclip,’ surgery square off for patients with failed mitral valve repair.
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