Sequana Medical NV, an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, has … continue reading “Strong Interim Results from Sequana Medical alfapump® DSR Study”
Clinical Studies/Trials
FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease
The U.S. FDA has granted Breakthrough Device Designation to Cala Trio™ for the treatment of action tremors in the hands … continue reading “FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease”
Formedix Expands Clinical Trial Automation Capability
Clinical trial automation software specialist, Formedix has announced expansion of its development and test teams. The Formedix platform helps companies … continue reading “Formedix Expands Clinical Trial Automation Capability”
Major New UK Study Highlights Risks of Post-Surgery Disc Prolapse
Data from one of the world’s largest spine studies identifies reherniation risk factors after prolapsed disc surgery. Background Surgical discectomy … continue reading “Major New UK Study Highlights Risks of Post-Surgery Disc Prolapse”
Medtronic DTM™ Spinal Cord Stimulation Therapy Outperforms Conventional SCS Therapy for Back Pain Relief at 12 Months
Statistically significant 12-month results from a large, multicenter randomized controlled trial confirm 84% Back Pain Responder Rate and 69% Profound … continue reading “Medtronic DTM™ Spinal Cord Stimulation Therapy Outperforms Conventional SCS Therapy for Back Pain Relief at 12 Months”
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”
First Two Patients for SELUTION SLR™ Sirolimus Drug Eluting Balloon Study
The first two patients have been enrolled in the PRISTINE registry with MedAlliance’s SELUTION SLR™ 018 Drug Eluting Balloon (DEB) … continue reading “First Two Patients for SELUTION SLR™ Sirolimus Drug Eluting Balloon Study”
Largest Therapeutic Study Says Cala Trio Essential Tremor Therapy Safe and Effective
Bioelectronic medicine company, Cala Health, Inc. says its landmark PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT), demonstrates safe and effective … continue reading “Largest Therapeutic Study Says Cala Trio Essential Tremor Therapy Safe and Effective”
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”
Rezūm™ Water Vapor BPH Therapy Effective After Five Years
New clinical study results say the Rezūm System provided significant, sustained improvement of lower urinary tract symptoms (LUTS) and quality of … continue reading “Rezūm™ Water Vapor BPH Therapy Effective After Five Years”
First Patient in SELUTION SLR™ Study for AV Fistula
MedAlliance has announced enrollment of the first patient in the SAVE* study utilizing their novel sirolimus-eluting balloon. The device is … continue reading “First Patient in SELUTION SLR™ Study for AV Fistula”
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”
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™”
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”
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”