CroíValve said today that it secured more than $4 million in additional financing as it develops a treatment for tricuspid regurgitation. The funding, which amounts to more than $4.4 million (€4 million) includes more than $2.7 million (€2.5 million) from the European Union under its Horizon 2020 SME Instrument grant. The remaining $1.7 million (€1.5 […]
Cardiac Implants
Cardiac Dimensions touts Carillon TMVR study
Cardiac Dimensions today touted a clinical study of its Carillon mitral contour system in treating the primary cause of functional mitral regurgitation (FRM) in patients with heart failure. Carillon is a right heart transcatheter mitral valve repair (TMVR) device designed to treat FRM in patients with mitral regurgitation grades of 2+, 3+ and 4+ in […]
CorWave touts LVAD study results
CorWave today touted 60-day study results from its preclinical study to evaluate its left ventricular assist device. The study concluded that the company’s LVAD has the ability to provide chronic circulatory support with outstanding hemocompatibility. “We were thrilled by the performance of the pump. This study bolsters the excellent hemocompatibility data from our previous trials, […]
Medtronic letter reveals Micra pacemaker deployment troubles
Medtronic has been fielding complaints from physicians who have had trouble releasing the company’s Micra pacemaker from its delivery system inside patients’ bodies. In a letter dated August 2019, the company noted that it had received 52 complaints worldwide involving a tangled tether that resulted in prolonged or additional procedures. Specifically, the company said it […]
EBR Systems wins FDA breakthrough nod for Wise CRT wireless pacer
EBR Systems said today that it has received breakthrough device designation from the FDA for its Wise CRT system for the treatment of heart failure. Sunnyvale, Calif.-based EBR Systems’ Wise system is a wireless pacer designed to improve the heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs […]
Occlutech wins CE Mark for intra-atrial shunt
Occlutech said today that its eponymous atrial flow regulator device received CE Mark approval in the European market. The Occlutech AFR is an intra-atrial shunt designed be placed between the left and right atria to treat heart failure symptoms by decompressing abnormal intra-atrial pressure. In a release, the Germany-based company said malfunction of the left […]
Orchestra BioMed wins CE Mark for BackBeat hypertension neurostim, names CMO
Orchestra BioMed said yesterday that it received the CE Mark for its Moderato implantable pulse generator system for BackBeat cardiac neuromodulation therapy (CNT), just nine days after naming a new chief medical officer. BackBeat therapy is a bioelectronic treatment designed to lower blood pressure while modulating the autonomic nervous system. The Moderato implantable device is […]
Trial will pit Nobles Medical’s PFO tech against Abbott’s for stroke reduction
The FDA has granted Nobles Medical Technologies II approval to conduct a prospective pivotal clinical trial for the expanded indication of patent foramen ovale (PFO) closure for reduction of recurrent ischemic stroke, according to the company. The FDA cleared the NobleStitch EL for cardiovascular suturing in April 2017. It was CE marked in Europe for […]
ESC Congress: Study shows bariatric surgery can improve cardiac outcomes in Type 2 diabetes
Bariatric or metabolic surgery can significantly lower the risk of major cardiovascular events among patients with Type 2 diabetes and obesity, according to a new clinical study released at the European Society of Cardiology Congress in Paris. The retrospective study followed 13,722 Type 2 diabetes patients who underwent bariatric surgery to lose weight or metabolic […]
Philips inks deal with LindaCare to put CRM monitoring into the cloud
Royal Philips (NYSE:PHG) said yesterday that it entered into an agreement with LindaCare to combine its IntelliSpace cardiovascular informatics platform with the latter’s OnePulse cloud-based monitoring system. The combination is intended to improve monitoring of patients with implanted cardiac rhythm management devices. Belgium-based LindaCare’s OnePulse is designed to aggregate data from CRM devices, bringing transmissions from […]
AtriCure wins expanded indications for AtriClip LAA
AtriCure (NSDQ:ATRC) said today that it won expanded 510(k) clearances from the FDA for its AtriClip left atrial appendage device. The new indications cover a change from occlusion of the LAA to exclusion and adding electrical isolation as a claim, Mason, Ohio-based AtriCure said. AtriClip excludes the LAA and causes its tissue to die from loss […]