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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Aerin Medical Announces Results of Randomized Controlled Trial Supporting VivAer® for Treatment of Nasal Airway Obstruction With Nasal Valve Collapse
Treatment with VivAer, a non-invasive, temperature-controlled, radiofrequency (RF) device, resulted in significant symptom relief, superior to sham control.
MD Orthopaedics Publishes Clubfoot Chronicles, One Parent’s Heartfelt and Personal Account of Life With a Clubfoot Child
Clubfoot is one of the most common musculoskeletal birth defects, affecting one out of every 100 babies born worldwide.
IntraOp Medical Announces First Patients Enrolled in FLASH Clinical Trial
Impulse Trial is the first to evaluate the curative potential of the FLASH Effect
Philips Enrolls 1st Patient in the WE-TRUST Global Multicenter Stroke Study
The first patient enrolled in global multi-center randomized controlled trial with 564 patients at 15 sites comparing the impact of the Direct to Angio Suite workflow (diagnosis and treatment in the angio suite) to the conventional workflow (diagnosis in the CT or MRI suite followed by treatment in the angio suite) on stroke patient outcomes. WE-TRUST trial to provide most comprehensive assessment to date with the help of an advanced brain scan technology in the angio suite for more effective and efficient stroke patient outcomes.
Medtronic Launches App-Based Study to Better Understand Relationship Between Atrial Fibrillation Disease Burden and Impact on Patient Outcomes
DEFINE AFib Study will leverage data from Medtronic insertable cardiac monitors and Medtronic Discovery App™ with the goal of informing atrial fibrillation (AF) management strategies
Medtronic InPen™ Real-World Data and Extended Infusion Set* Pivotal Trial Results Demonstrate Strong Clinical Outcomes and Positive User Experience
Medtronic presented real-world clinical results that compared glycemic outcomes for 1,736 individuals before and after using the InPen smart1 insulin pen for 90 days with a glucose monitor
Insulet to Present New Clinical Data for Preschool Children and Adults using the Omnipod® 5 System
Insulet will present new clinical outcomes data for preschool children with type 1 diabetes using the Omnipod 5 Automated Insulin Delivery System (Omnipod 5).
BioSig Technologies Announces PURE-EP System Clinical Data
PURE EP System is designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals during complex ablation procedures.
DEFINE GPS Global Multicenter Study – First Patient Enrolled: Study to assess Superiority of PCI Procedures Guided by Co-registered iFR and Interventional Angiography
The global, multi-center, prospective, randomized controlled DEFINE GPS study will investigate if guidance by instantaneous wave-free ratio (iFR) measurements co-registered on the angiogram demonstrates superior outcomes and improves the cost-effectiveness of percutaneous coronary intervention (PCI) procedures to open blocked coronary arteries.