Positive results from Limflow SA’s PROMISE II U.S. pivotal trial show its Limflow system for transcatheter arterialization of deep veins (TADV) led to sustained amputation-free survival and wound healing in patients with chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease. According to the Paris-based company, 76% of CLTI patients who received Limflow therapy were able to avoid an otherwise life-saving major amputation.
Yongrenxin Medical Instrument Co. Ltd. raised nearly $100 million in a series A funding round to build a health platform to treat heart failures. Sinovac Biotech Ltd. led the round.
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.
Feops NV hopes to raise €10 million (US$10.67 million) in a series C fundraising round that will allow the company to scale up its operations worldwide. This follows the release of a study in JACC: Cardiovascular Interventions which revealed that its cloud-based platform, Feops Heartguide, significantly improved efficiency and outcomes of left atrial appendage closure (LAAC) procedures.
New data presented at the Cardiovascular Research Technologies (CRT) 2023 meeting reinforced the safety and effectiveness of Boston Scientific Corp.’s Watchman FLX left atrial appendage occlusion (LAAO) device in routine, real-world clinical care. Building on positive 45-day outcomes presented at CRT 2022, the analysis shows sustained low stroke rate at one year, including ischemic stroke.
Pulsed field ablation (PFA) may not be the final word where energy sources for atrial fibrillation (AF) ablation are concerned, but several companies have adopted development programs that propose the use of PFA as an alternative to conventional energy sources. Dublin-based Medtronic plc appears to have at least a narrow lead over the competition in the PFA space thanks to the results of the PULSED AF pivotal study presented at the 2023 American College of Cardiology Scientific Sessions.
Europe has given device makers more time to meet requirements set out in the 2017 Medical Devices Regulation (MDR). The European Parliament approved in mid-February an extension of the transition periods for medical device and IVD manufacturers to comply with the new rules, which aim to enhance safety for patients and ensure the “smooth functioning of the internal market.”
Abbott Laboratories continues to push its presence in the cardiovascular market with offerings for the left atrial appendage (LAA) closure and transcatheter aortic valve implant (TAVI) markets, both of which generated affirmative data presented at this year’s edition of the annual meeting of Cardiovascular Research Technologies (CRT 2023) in Washington.
Affluent Medical SA reported the imminent raising of nearly $14 million to fund development throughout 2023 of its implantable medical devices for treating urinary incontinence and heart valve pathology. Affluent, quoted on the Paris Euronext stock exchange since 2021, issued new shares accompanied by redeemable share warrants with shareholder preferential subscription rights being preserved.
Previa Medical SA will begin clinical trials later this year of its artificial intelligence software designed for early detection of sepsis after it raised €2.1 million (US $2.2 million) in seed funds.
