The European Investment Bank (EIB) pumped €15 million (US$17 million) into Xeltis BV to accelerate clinical programs for its polymer-based technology platform for cardiovascular restoration. The Eindhoven, Netherlands-based company is developing three types of cardiovascular implants. These are a pulmonary heart valve, coronary artery bypass graft and hemodialysis access grafts. The devices use a therapeutic approach called endogenous tissue restoration (ETR), which causes the patient’s own body to naturally restore a new blood valve. As the patient’s healing system develops a functional valve, Xeltis’ implant is gradually absorbed by the body.

PERTH, Australia – Cardiovascular medical device company EBR Systems Inc. announced a planned AU$110 million (US$79.7 million) initial public offering (IPO) on Australia’s Securities Exchange to bring its wireless cardiac pacing system for heart failure to market. The IPO is planned for Nov. 24, 2021, and the funds raised will allow the company to complete pivotal trials for its wireless, inside-the-left-ventricle-of-the-heart pacing system called WiSE (wireless stimulation endocardially).

Pulse Medical Imaging Technology Co. Ltd.’s latest trial showed its quantitative flow ratio (QFR) guidance provided a 35% risk reduction in the one-year rate of major adverse cardiac events, compared to standard angiography guidance. QFR, developed by Pulse, could be used to guide the strategy and optimization of percutaneous coronary intervention.

Dublin-based Medtronic plc’s Micra pacemaker was a groundbreaking device when the FDA approved the leadless pacemaker in 2016, thanks to the elimination of the hazards associated with pacemaker leads. However, the FDA said recently that the risks associated with cardiac perforation with leadless pacemakers, such as tamponade or death, might be higher with the Micra than with pacemakers with leads.

Vuno Inc. has received its third breakthrough device designation from South Korea’s Ministry of Food and Drug Safety (MFDS), for its artificial intelligence (AI)-based electrocardiogram (ECG) analysis software Vuno Med DeepECG. Vuno is the first company to have three such designations to its name. “We developed Vuno Med DeepECG via long-term ECG data analysis research. With this breakthrough designation, we target expanding our market share in the medical AI industry via our bio-signal businesses. Among these is ECG data, which can help diagnose various heart diseases and has high potential,” Yeha Lee, chairman at Vuno, told BioWorld.

The FDA granted Cardialen Inc. an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF). MPT is a low-energy electrical pulse therapy aimed at restoring abnormally rapid heart rates, such as AF, to a regular rhythm to reduce the potential for high-energy shocks. Studies have shown that almost 1 in 4 patients experience anxiety or depression after receiving an implantable cardioverter defibrillator (ICD).

PARIS – Incepto Medical SAS, in partnership with Marie-Lannelongue Hospital, is developing an automated system to measure maximum aorta diameter. Called ARVA (Augmented Radiology for Vascular Aneurysm), it’s hosted in the cloud and is CE marked as a class I device. “Our tool uses the first algorithm to provide automatic measurement of external aortic diameter along the entire aorta, from ascending aorta to the iliac arteries,” Antoine Jomier, co-founder and CEO of Incepto, told BioWorld. This new tool for radiologists and surgeons will be used to diagnosis and monitor aneurysms.

Shares of cardiac diagnostics company Heartbeam Inc. (NASDAQ:BEAT) are trading lower than expected after it opened on the Nasdaq on Nov. 11. The digital health company priced its public offering of 2,750,000 units at $6, but as of midday, shares were trading at $4.56. It’s a disappointing start for the Santa Clara, Calif.-based company, which is developing an ECG telemedicine technology to diagnose cardiovascular patients for ambulatory settings.

PARIS – Royal Philips NV has signed a deal to acquire Cardiologs Technologies SAS and its artificial intelligence technology. The financial terms surrounding the transaction have not been disclosed. The two companies expect to close the deal in the coming months.