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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
SPACE-AF Study Update: Galaxy Medical Reports 1st Patient Is Enrolled
Atul Verma, MD, Head of the Heart Rhythm program at Southlake Regional Health Centre and Primary Investigator in the SPACE-AF study commented: "We are thrilled to launch the first study of focal ablation through a solid tip catheter with PEF to treat both the pulmonary veins and atrial targets beyond the pulmonary veins including the left atrial posterior wall.
New Study Shows Consistent Medical-Grade Accuracy and Environmental Benefits to Replacing Mercury Sphygmomanometers with OMRON HEM-907XL
Published research supported by the CDC highlights environmental and cost-savings benefits of replacing mercury sphygmomanometers with electronic blood pressure monitors.
CureApp Hypertension Therapeutics App: Clinical Trial Results Published in the European Heart Journal
Japan’s first major leap toward digital therapeutics in the field of hypertension .
Miach Orthopaedics Initiates Post-Market Study for BEAR® Implant
Miach Orthopedics initiated BEAR III to continue to build upon the extensive base of evidence for the BEAR Implant, which recently received De Novo approval from the U.S. Food and Drug Administration.
Results of a Dual-Site Study Involving the Non-Invasive vMap System™ During SAbR Published In Heart Rhythm O2
An article published by the Heart Rhythm Society’s journal Heart Rhythm O2 concludes that Vektor’s Computational ECG Mapping System (vMap™) and protocol-based respiratory gating may help facilitate radioablation planning and maintain efficacy during therapy.
NuVasive Simplify Cervical Disc Data Published In International Journal Of Spine Surgery
The Simplify Cervical Disc is part of the NuVasive C360™ portfolio, which offers comprehensive, procedurally integrated solutions for the cervical spine across ACDF, posterior cervical fusion, and cTDR procedures.
HeartFlow Announces Enrollment of First Three Patients in FUSION Trial
“Both in clinical trials and real-world clinical practice, we have seen that the use of the HeartFlow Analysis in a coronary diagnostic pathway delivers a significant reduction in invasive angiograms which are in retrospect unnecessary,” said Campbell Rogers, MD, FACC, Chief Medical Officer, HeartFlow.
1st Patient Enrolled in the 3,300 Patient Landmark Sirolimus DEB vs DES Study
SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary arterial disease in May 2020. The US FDA has awarded the SELUTION SLR with four breakthrough designations for coronaries, peripheral vascular and AV Fistula indications.
XACT ACE™ Robotic System Pivotal Trial Enrollment Completed
Lahey Hospital & Medical Center (LHMC) and Sarasota Interventional Radiology (SIR) participated in a trial to evaluate the safety and accuracy of percutaneous procedures in the lung using the XACT ACE™ Robotic System for instrument insertion. The procedure has the potential to support the earlier and less invasive confirmation of lung cancer in patients.