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”
Clinical Studies/Trials
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”
Positives for Broncus BTVA System
Broncus Medical, Inc., talks of the publication of results from the VAPORIZE study in the current issue of Respiration. The paper’s authors conclude that, … continue reading “Positives for Broncus BTVA System”
Japan Approves LimFlow Study
Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved LimFlow’s Clinical Trial Notification (CTN) for the Japanese cohort of the … continue reading “Japan Approves LimFlow Study”
CairnSurgical Breast Cancer Locator Trial Begins
The first patient has been treated in a U.S. pivotal trial of CairnSurgical’s Breast Cancer Locator (BCL) System. The system is … continue reading “CairnSurgical Breast Cancer Locator Trial Begins”
FDA OKs ReCor Paradise™ Ultrasound Renal Denervation
ReCor Medical’s Paradise™ Ultrasound Renal Denervation System has received Breakthrough Device Designation from the U.S. FDA for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.
App Boost for BioTech Businesses
Berlin-based Biotech networking company A-LabInsider has created an app that is a resource listing all academic life science labs in … continue reading “App Boost for BioTech Businesses”
Strong Interim Results from Sequana Medical alfapump® DSR Study
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”
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”