PARIS – Orixha SAS raised $2.25 million to bolster development of its Vent2cool medical device, pulmonary ventilation technology used in critical care settings. Investment company Erganeo SAS, the Angels Santé business angels group and three French industrial partners – Infiplast SAS, OEM Development SAS and Activation SAS – all participated in the round.

TORONTO – Opsens Inc. has successfully treated 20 patients in the first-in-human study employing a new surgical guidewire to improve procedural workflow during transcatheter aortic valve replacement (TAVR). According to Opsens CEO Louis Laflamme, the Savvywire will be the first guidewire to deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.

In the Dec. 3, 2021, issue of Science, researchers reported that a missense variant that is highly enriched in the Amish population was associated with reduced levels of both LDL cholesterol and fibrinogen. To date, very few variants have been identified that affect more than one risk factor for cardiovascular disease.

Restore Medical Ltd. is implanting the first patients with its Contraband technology for congestive heart failure (CHF). The minimally invasive, catheter-delivered implant is being assessed in patients with chronic left ventricular failure. The Or Yehuda, Israel-based startup is carrying out the trial at the ZNA medical center in Antwerp, Belgium, followed by the Kaplan medical center in Israel. The goal of the implant is to enable the right ventricle to strengthen the left ventricle and improve ejection fraction, reduce mitral regurgitation and restore a favorable ventricular geometry.

PERTH, Australia – Medtech newcomer Artrya Ltd. listed on the Australian Securities Exchange (ASX) in an AU$40 million (US$28.6 million) initial public offering to commercialize its software that analyzes heart computed tomography (CT) scans via artificial intelligence (AI) to better diagnose coronary artery disease.

The U.K. National Institute of Health and Care Excellence (NICE) issued two health technology assessments dated Nov. 24, including one that gives a guarded recommendation for devices used to narrow the coronary sinus as a treatment for refractory angina. Neovasc Inc., of Richmond, British Columbia, touted the news as a positive for its Reducer device, given that this is the first instance in which NICE has lent any support for a device to treat the condition.

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.