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”
Cardio
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”
CVRx®Barostim™ Heart Failure System Gains MR-Conditional Labeling 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”
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™”
First O.U.S. Patients Get TRIA Biopolymer Surgical Aortic Valve™
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™”
Study Shows Promise for Next-Generation Cardiac Ablation Tech
Argá Medtech’s next-generation non-thermal cardiac ablation system shows promise in improving precision, speed and flexibility in treating atrial fibrillation, says … continue reading “Study Shows Promise for Next-Generation Cardiac Ablation Tech”
vMAP™ Arrhythmia Hot Spot Detection System FDA Cleared
Vektor Medical, Inc. has gained U.S. FDA 510(k) clearance for its novel computational ECG mapping system, vMap™. The non-invasive technology … continue reading “vMAP™ Arrhythmia Hot Spot Detection System FDA Cleared”
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”
Renal Denervation Back in Europe with ReCor Paradise™ Launch
Treatment supported by evidence from multiple studies and Renal Denervation Position Paper from the European Society of Hypertension Background It’s … continue reading “Renal Denervation Back in Europe with ReCor Paradise™ Launch”
$17m New Finance for 4D Cardiac Imaging Tech
Imagine four-dimensional (4D) imagery of the beating heart, viewed live, in 360°. Now add real-time tissue analysis to the same … continue reading “$17m New Finance for 4D Cardiac Imaging Tech”
Enrollment Complete in Tria™ Biopolymer Valve Study
The novel TRIA™ surgical aortic heart valve from Foldax®, Inc. has completed enrollment in its U.S. early feasibility study. Background Foldax … continue reading “Enrollment Complete in Tria™ Biopolymer Valve 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”
Carpediem™ First Cardio-Renal Pediatric Dialysis Launch
Medtronic plc has announced the U.S. commercial launch of the Carpediem™ Cardio-Renal Pediatric Dialysis Emergency Machine, the first and only … continue reading “Carpediem™ First Cardio-Renal Pediatric Dialysis Launch”
Penumbra’s Indigo® Cleared for Pulmonary Embolism
Penumbra, Inc. has announced U.S. FDA 510(k) clearance for expanded indication of the Indigo® Aspiration System, Lightning™ 12. Background Pulmonary embolism, … continue reading “Penumbra’s Indigo® Cleared for Pulmonary Embolism”