Cardio

Boston Scientific Corporation tells us it has obtained CE mark for the ACURATE Prime™ Aortic Valve System. Indeed it is … continue reading “ACURATE Prime™, Boston Scientific’s New Aortic Valve System Gains CE Mark”

Last month (July 2024) Edwards Lifesciences announced it is to acquire JenaValve Technology, a pioneer in the transcatheter treatment of aortic … continue reading “Trio of Acquisitions to Reinforce Edwards Lifesciences Heart Portfolio”

New funding will be used to support Jupiter Endovascular in its upcoming pivotal trial for Pulmonary Embolism. It will also … continue reading “Jupiter Endovascular Funding Means Green Light for Pulmonary Embolism Pivotal Trial”

The Emboliner “Protect the Head to Head” investigational device exemption (IDE) clinical trial has seen its one hundredth patient enrolled. … continue reading “Emboliner ® IDE Study 100 Patient Milestone”

Biosense Webster, Inc., has announced European CE mark approval of the VARIPULSE™ Platform. The approval covers the treatment of symptomatic drug refractory … continue reading “VARIPULSE™ Pulse Field Ablation (PFA) Platform Gains CE Mark”

Heart Valve Pioneer Foldax® Inc., will see its innovative TRIA™ polymer mitral surgical heart valves being manufactured in India. A newly … continue reading “Foldax Signs Indian Manufacturer to Help Expedite Mitral Valve Commercialization in the Country”

The global drug eluting stent (DES) market size is expected to reach USD 13.65 billion by 2030, advancing at a … continue reading “Drug Eluting Stent Market Growth Predicted”

Powerful Medical, Inc. has unveiled what it calls a significant advancement in the fight against heart disease. The aptly named … continue reading “Heart Attack Detection Better with AI”

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) have announced the U.S. … continue reading “FDA approves Recor Medical’s Paradise™ Ultrasound Renal Denervation for Hypertension”

The first US patient has been enrolled at Medstar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to … continue reading “SELUTION SLR Coronary Sirolimus DEB Study: First US Patient Enrolled”

CVRx, Inc., developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its … continue reading “Neuromodulation specialist CVRx Launches new Barostim NEO2™ Implantable Pulse Generator”

Swiss company Argá Medtech has begun enrollment in a First-in-Human Clinical Trial of its CSE Ablation System in the treatment … continue reading “First-in-Human Trial will Assess the Safety and Effectiveness of Coherent Sine Wave Electroporation in Patients with Atrial Fibrillation”

MedAlliance’s SELUTION SLR™ drug-eluting balloon (DEB) has received FDA Investigational Device Exemption (IDE) approval, making it the first limus DEB … continue reading “First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval”

CVRx, Inc., developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure, has received U.S. … continue reading “CVRx®Barostim™ Heart Failure System Gains MR-Conditional Labeling Approval”

Biosensors International Group, Ltd. has announced the Japanese PMDA Approval for BioFreedom™ Ultra and US FDA Approval for BioFreedom™. Background … continue reading “Japanese PMDA Approval for BioFreedom™ Ultra and US FDA Approval for BioFreedom™”

Foldax®, Inc. says the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of … continue reading “First O.U.S. Patients Get TRIA Biopolymer Surgical Aortic Valve™”