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”
Cardio
First Patients in Europe Treated with Biosense Webster VARIPULSE® AF Catheter
Johnson & Johnson Medical Devices Companies’ Biosense Webster, Inc., says the first patients have been enrolled and treated in its … continue reading “First Patients in Europe Treated with Biosense Webster VARIPULSE® AF Catheter”
FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation
Johnson & Johnson Medical Devices Companies have announced the U.S. FDA approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH® SF Ablation … continue reading “FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation”
Cases Resume in BioCardia CardiAMP Heart Trial
Cardiovascular regenerative therapies company BioCardia®, Inc., tells us it has resumed cases in the CardiAMP Heart Failure Trial. The first … continue reading “Cases Resume in BioCardia CardiAMP Heart Trial”
First Scoring Guidelines Validated for WatchPAT™ Sleep Apnea Diagnostic
Respiratory Sleep Disorder specialist, Itamar Medical Ltd. has announced publication of results of the COMPASS study. The upshot sees validated … continue reading “First Scoring Guidelines Validated for WatchPAT™ Sleep Apnea Diagnostic”
Revivent TC Less Invasive Ventricular Enhancement Therapy CE Mark Extended to 2024
BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, has announced the extension … continue reading “Revivent TC Less Invasive Ventricular Enhancement Therapy CE Mark Extended to 2024”
Promise for Emboliner™ Embolic Protection Catheter as Safepass 2 Study Completes Enrollment
Emboline™, Inc., developer of total embolic protection technology for transcatheter aortic valve replacement (TAVR), has announced completion of enrollment in its … continue reading “Promise for Emboliner™ Embolic Protection Catheter as Safepass 2 Study Completes Enrollment”
Positive One-Year Outcomes for BioVentrix Revivent TC™
The BioVentrix Revivent TC™, the first “less invasive” system for left ventricular remodeling, has yielded positive one-year results in an online … continue reading “Positive One-Year Outcomes for BioVentrix Revivent TC™”
Glenfield to become one of first UK Hospitals to offer Boston Scientific’s WATCHMAN FLX™
Leicester’s Glenfield Hospital is to introduce the latest stroke-preventing cardiac implant, through Althea’s Consumable Management Service (CMS). Background Atrial fibrillation … continue reading “Glenfield to become one of first UK Hospitals to offer Boston Scientific’s WATCHMAN FLX™”
Blue Shield of CA and Blue Cross Blue Shield Federal Employee Plan to Include Itamar WatchPAT™ in Their Policies
Non-invasive diagnostic sleep apnea device expert Itamar Medical Ltd. has announced that Blue Shield of California (BSC) and the Blue … continue reading “Blue Shield of CA and Blue Cross Blue Shield Federal Employee Plan to Include Itamar WatchPAT™ in Their Policies”
Limited Release of BioCardia AVANCE™ Steerable CV Catheter Introducer
Following its recent FDA clearance, BioCardia, Inc. has confirmed the U.S. commercial availability of the AVANCE™ Bi-Directional Steerable Introducer Sheath for introducing … continue reading “Limited Release of BioCardia AVANCE™ Steerable CV Catheter Introducer”
First Patient Enrolled in Coronary Mechanical Thrombus Aspiration Study
Penumbra, Inc., tells us it has seen enrollment of the first patient into a prospective, multi-center U.S. study to evaluate … continue reading “First Patient Enrolled in Coronary Mechanical Thrombus Aspiration Study”
FDA Breakthrough Device Designation for SoniVie’s TIVUS Pulmonary Arterial Hypertension System
Pulmonary Arterial Hypertension (PAH) treatment specialist SoniVie, has been granted Breakthrough Device Designation from the U.S. FDA for the Therapeutic … continue reading “FDA Breakthrough Device Designation for SoniVie’s TIVUS Pulmonary Arterial Hypertension System”
Abbott Launches World’s First Pivotal Trial to Test Leaky Tricuspid Heart Valve Repair System
Abbott has announced the launch of the TRILUMINATE Pivotal trial to evaluate the safety and effectiveness of its TriClip transcatheter … continue reading “Abbott Launches World’s First Pivotal Trial to Test Leaky Tricuspid Heart Valve Repair System”
CE Mark for Orchestra BioMed BackBeat Cardiac Neuromodulation Therapy™ for Hypertension
Orchestra BioMed™, Inc., tells us it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat … continue reading “CE Mark for Orchestra BioMed BackBeat Cardiac Neuromodulation Therapy™ for Hypertension”
U.S. Approval for Next-Generation MitraClip®
Abbott tells us it has received U.S. FDA approval for the fourth generation of of its MitraClip™ heart valve repair device to treat … continue reading “U.S. Approval for Next-Generation MitraClip®”