Boston Scientific Corporation has announced the CE Mark approval of its Vercise™ Neural Navigator 3 directional Deep Brain Stimulation (DBS) programming … continue reading “CE Mark for Boston Scientific’s VERCISE™ Neural Navigator 3 Programming Software”
Specialty
Deltex to Push TrueVue Development with Grant Award
Oesophageal Doppler Monitoring specialist Deltex Medical Group plc says its wholly owned UK subsidiary, Deltex Medical Limited, has been awarded … continue reading “Deltex to Push TrueVue Development with Grant Award”
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”
Medtronic Submits InterStim™ Micro Neurostimulator and SureScan™ MRI Leads to FDA
Medtronic plc tells us it has filed a pre-market approval (PMA) supplement with the U.S. FDA for approval of its … continue reading “Medtronic Submits InterStim™ Micro Neurostimulator and SureScan™ MRI Leads to FDA”
Ethicon’s New Stapler Targets Anastomotic Leak Reduction
J & J company, Ethicon has announced the launch of the ECHELON CIRCULAR™ Powered Stapler which preclinical studies say reduce … continue reading “Ethicon’s New Stapler Targets Anastomotic Leak Reduction”
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”
Boston Scientific’s New TACTRA™ Penile Prosthesis
This new implant provides patients with a durable, natural-feeling implant for the treatment of erectile dysfunction. Background Erectile dysfunction (ED) … continue reading “Boston Scientific’s New TACTRA™ Penile Prosthesis”
Bioengineered Repair Mimics Native ACL Says New Study
Results of a study published online in the American Journal of Sports Medicine show torn anterior cruciate ligaments (ACLs) treated with the Miach … continue reading “Bioengineered Repair Mimics Native ACL Says New Study”
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®”
Carotid Artery Disease Patients do Better with TCAR than Endarterectomy
Silk Road Medical Inc. has announced the presentation of real-world data from two studies into the treatment of patients with … continue reading “Carotid Artery Disease Patients do Better with TCAR than Endarterectomy”
Medtronic’s EvolveSM Workflow with Spinal Cord Stimulation Offers Hope for Back and Leg Pain Sufferers, Says Study
Prospective data demonstrates effective pain relief and improved function in patients with intractable back and leg pain
FDA Clearance of Steerable Introducer for Transseptal Access/Delivery
BioCardia shows its newly cleared transseptal access system at Heart Rhythm Society congress in San Francisco
Non-Invasive Headache Therapy System Selected for NHS England Innovation and Technology Payment Program
electroCore’s gammaCore™ chosen by NHS England to be funded by the Innovation and Technology Payment Program to support adoption in the U.K.