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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
First Sirolimus DEB Patient Enrolled in Japanese SELUTION SLR™ Study
The SELUTION SLR™ Study involves up to 132 patients across a number of centres in Japan. Its objective is to assess the safety and efficacy of SELUTION SLR for the treatment of lesions of superficial femoral arteries and/or popliteal arteries.
Masimo SET® Pulse Oximetry New Study Expands Evidence Demonstrating the Benefits of Critical Congenital Heart Disease (CCHD) Screening
The authors concluded that “Our results encourage us to strengthen screening for CCHD by adding pulse oximetry to the routine newborn screening panel.”
Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis
The trial reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial in December 2019 and the control arm has achieved its target of 160 patients. To date, a total of 168 study subjects have reached 12 months follow up.
MediPines Releases Scientific Paper on COVID-19 Respiratory Monitoring
Amidst this global crisis, innovative hospitals across the United States and Canada are leveraging a new respiratory monitoring system, the MediPines AGM100®.
BIOLASE Reports Landmark Head-to-Head Study Published in Journal of Periodontology Concludes That BIOLASE REPAIR® Perio Protocol is Superior for Procedure Time and Patient-Reported Outcomes
The study found that the REPAIR Perio protocol had shorter procedure times than open flap procedures, as well as less bruising, swelling, and post-operative bleeding, demonstrating that REPAIR is as effective as open flap procedures in clinical parameters, such as pocket depth and attachment level, but with significantly better patient-reported outcomes.
MedAlliance Announces Enrollment of the 1st Patient In Its SELUTION SLR™ 014 DEB Study for the treatment of In-Stent Restenosis
The objectives of this prospective, randomized, single-blind multicenter study are to demonstrate the safety and efficacy o SELUTION SLR™ 014 DEB n the treatment of ISR with either drug-eluting or bare-metal stents. The study will support the submission for FDA approval.
LaunchPad Medical Receives Approval to Start a Clinical Trial in the United Kingdom to Study its Bone Adhesive Biomaterial in the Field of Implant...
This study will focus specifically on anterior teeth located in the aesthetic or "smile" region where the loss of a tooth is highly visible.
BIOMODEX: Results of First Clinical Study Using Patient-Specific Brain Aneurysm Models for Pre-Procedural Rehearsals
Published in the Journal of NeuroInterventional Surgery (JNIS) this month, the findings demonstrates how use of the 3D printed aneurysm models for pre-procedural rehearsal allows physicians to rehearse for procedures more accurately and reliably.
NuvoAir Announced Publication of Two Abstracts from the Royal Brompton Hospital, London, UK
The abstracts, published in the June supplement of the Journal of Cystic Fibrosis, were originally submitted to the 2020 European Cystic Fibrosis Conference in Lyon, France, prior to its cancellation.
