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 […]
Functional Neuromodulation launches Alzheimer’s DBS trial
Functional Neuromodulation said yesterday that it has begun a pivotal clinical trial to assess deep brain stimulation (DBS) in patients with mild Alzheimer’s disease. The Minneapolis-based company said the study will evaluate the safety and efficacy of stimulating the fornix (DBS-f) — a major inflow and output pathway in the brain’s memory circuit. Research suggests […]
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 […]
WishBone Medical to launch growth control plating system for kids
WishBone Medical today said it will launch its growth control plating system for kids at the end of September this year. The growth control plating system is a single-use procedure kit in sterile packaging that is designed to treat angular limb deformities in children. Physicians can use the growth control plates to redirect the growth […]
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 […]
J&J’s DePuy Synthes launches Attune cementless knee
Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes division said today it is launching the Attune cementless knee in a rotating platform option in select markets around the world. This launch combines the proprietary technologies of the Attune knee designed to provide stability while the knee is in motion with DePuy Synthes’ background in rotating platform knees […]
FDA clears Arthrosurface’s Boss toe implant
Arthrosurface said yesterday that it received FDA 510(k) clearance for its Boss toe fixation system, which the company believes will be commercially available at the end of the month. The Franklin, Mass.-based company said the Boss system is designed to improve stabilization in the first metatarsal with a distal bone void and to provide patients […]
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 […]
J&J’s DePuy to acquire JointPoint hip navigation software
Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes said it agreed to acquire JointPoint and its surgeon-friendly navigation software for hip replacements for an undisclosed amount. Belleair Bluffs, Fla.-based JointPoint’s OneTrial software is designed to improve surgical outcomes in hip replacements by analyzing implant selection and positioning pre-surgical digital templating and case planning through non-invasive computer […]
LivaNova wins Medicare nod for nerve stimulation trial
Medicare has approved a LivaNova (NSDQ:LIVN) study of vagus nerve stimulation (VNS) to treat depression, the company said today. The Centers for Medicare and Medicaid Services accepted the London-based company’s protocol for a clinical trial to study the safety and effectiveness of adding VNS to traditional depression treatment in patients with treatment-resistant depression. Approval of […]
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 […]
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