Neuromodulation specialist CVRx Launches new Barostim NEO2™ Implantable Pulse Generator

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”

First-in-Human Trial will Assess the Safety and Effectiveness of Coherent Sine Wave Electroporation in Patients with Atrial Fibrillation

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”

First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval

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”

Japanese PMDA Approval for BioFreedom™ Ultra and US FDA Approval for BioFreedom™

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™”

Continuous Aspiration Thrombectomy with Penumbra Indigo® System CAT™RX Safe and Effective Says New Study

Success for Penumbra Inc.’s Indigo® System CATTM RX Catheter in a newly reported study. The device met the primary endpoint and demonstrated high rates of blood clot … continue reading “Continuous Aspiration Thrombectomy with Penumbra Indigo® System CAT™RX Safe and Effective Says New Study”

First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve

Based in Eindhoven, Netherlands, Xeltis is a clinical-stage developer of advanced polymer-based restorative cardiovascular devices. The company has now announced … continue reading “First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve”