Venus Medtech (Hangzhou) Inc. reported it has acquired 100% equity interest and corresponding equity in Cardiovalve Ltd. for $300 million. Or Yehuda, Israel-based Cardiovalve produces the Cardiovalve system, a transcatheter interventional replacement product for mitral or tricuspid regurgitation.
Stereotaxis Corp. reported positive results showing its robotic magnetic navigation (RMN) system significantly reduces the incidence of silent cerebral embolism (SCE) in patients undergoing atrial fibrillation (AF) ablation vs. hand-held catheters. The prospective, multicenter study is believed to be the first to compare AF ablation using RMN with manual control and to highlight the benefit in lowering SCE risk.
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.
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia. The company had reported in December 2020 that the allogeneic mesenchymal cell therapy failed to meet the primary endpoint of a reduction in hospitalizations in its DREAM-HF phase III trial.
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.
Longeveron Inc.’s share price (NASDAQ:LGVN) jumped 11.7% on Dec. 3 after the FDA awarded orphan designation to Lomecel-B, allogeneic bone marrow-derived mesenchymal stem cells, for treating hypoplastic left heart syndrome. The designation came two weeks after the FDA granted rare pediatric disease designation for Lomecel-B to treat the life-threatening congenital heart defect in infants.
In the December 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.
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