Biosense Webster Inc. scored approval from Japan’s Ministry of Health Labour and Welfare’s (MHLW) for its Varipulse pulsed field ablation platform to treat symptomatic drug-refractory recurrent paroxysmal atrial fibrillation on Jan. 9., making it the first PFA system approved in the country.
There is a strong relationship between heart failure (HF) and atrial fibrillation (AF): half of the patients with HF acquire AF. Recent studies discovered a genetic basis underlying AF, which demonstrated a strong heritable component to this disease.
Bayer AG’s asundexian, considered one of the next generation class of anticoagulants and a potential blockbuster, has failed a phase III clinical trial in atrial fibrillation. The factor XIa inhibitor is one of three with a similar mechanism of action in late stage development by big companies.
A recognized link exists between oxidative stress, obesity and atrial fibrillation (AF). NADPH oxidase 2 (NOX2) serves as a significant contributor to reactive oxygen species (ROS) production in the heart, and it is known to be elevated in obese mice.
South Korea’s Chong Kun Dang Pharmaceuticals Corp. said that it struck a deal potentially worth $1.3 billion with Swiss pharma giant Novartis AG for its CKD-510 candidate for neurological and cardiovascular diseases, propelling its shares upward 26.11% by market closing of Nov. 6. With the “largest ever” deal in its history, shares of the Seoul-based pharmaceutical (KOSPI:185750) on the Korea Exchange rose by 26.11%, or ₩26,500, closing at ₩128,000 ($98.70).
South Korea’s Chong Kun Dang Pharmaceuticals Corp. said that it struck a deal potentially worth $1.3 billion with Swiss pharma giant Novartis AG for its CKD-510 candidate for neurological and cardiovascular diseases, propelling its shares upward 26.11% by market closing of Nov. 6. With the “largest ever” deal in its history, shares of the Seoul-based pharmaceutical (KOSPI:185750) on the Korea Exchange rose by 26.11%, or ₩26,500, closing at ₩128,000 ($98.70).
Anthos Therapeutics Inc.’s phase II study of abelacimab in treating atrial fibrillation in patients at moderate to high risk of stroke has met its primary endpoint. The data monitoring committee stopped the study early as the fully human monoclonal antibody targeting factor XI/XIa reduced bleeding when compared to a leading standard of care, direct oral anticoagulant, Xarelto (rivaroxaban, Johnson & Johnson).
The pivotal ADVENT trial of the Farapulse pulsed field ablation (PFA) system developed by Boston Scientific Corp. returned positive results at one year, according to a presentation at the ESC Congress 2023 that was simultaneously published in the New England Journal of Medicine. The study compared Farapulse, a nonthermal treatment that ablates heart tissue, to radiofrequency or cryoablation, the current standards of care for paroxysmal atrial fibrillation.
Boston Scientific Corp. has managed its Polarx device to another regulatory approval, this time a nod from the U.S. FDA, giving the company access to one of the world's premier markets. The news comes four months after the company obtained a CE mark for the device, opening the door to two jumbo markets in a move the company hopes will ensure the device will provide solid returns on its investment.
It's one thing to ablate a lesion to treat a cardiac arrhythmia “but you can’t ablate the right place if you don’t know where it is,” said Nikki Sidi, U.S. President ofBiosense Webster Inc. Sidi was commenting on the July 24 U.S. launch of the high-density diagnostic Optrell mapping catheter with Trueref technology powered by its Carto 3 software.
