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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Synedgen RCT Underway: Test Safety of SynPure & Catasyn
Synedgen: RCT Underway to Test Safety of SynPure and Catasyn
Synedgen, a biotechnology company using glycopolymer chemistry to develop therapeutics that enhance and control signaling...
Positive Aerin Medical AERWAY Study Results Published Showing Effectiveness of VivAer® For Nasal Obstruction Patients with Nasal Valve Collapse
Study adds to a growing body of clinical evidence supporting the safety and efficacy of VivAer, a non-invasive, temperature-controlled radiofrequency device.
HRS Scientific Sessions: Boston Scientific LBCT
During the Heart Rhythm Scientific Sessions this week, Boston Scientific announced positive LBCT data underscoring the safety and efficacy of multi-site pacing (MSP) over conventional cardiac resynchronization therapy (CRT), as well as poster presentations on real-world use of the WATCHMAN Left Atrial Appendage Closure (LAAC) device and next-generation WATCHMAN FLX LAAC device as alternatives to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation.
The LimFlow System Found to be Cost-Effective, According to the Newest Study Published in the Journal of Critical Limb Ischemia
Percutaneous Deep Vein Arterialization (pDVA) with the LimFlow System offers a cost-effective and high-value alternative to traditional therapies or amputation in a new study, published June 2021.
FoodMarble AIRE Shown to Exceed the Performance of ‘Gold Standard’ SIBO Testing in Clinical Trial
SIBO is a very common disorder where there are excessive bacteria present in the small intestine. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.
Venock Reports Safety/Efficacy of Its Automated Closure Device for Large Bore Venous Access Sites as Alternative to Standard Manual Compression of Veins/Arteries in Interventional...
The Venock device is designed to attain large-bore venous closure in under a minute.
Smith+Nephew REGENETEN Bioinductive Implant New Study
Smith+Nephew (LSE:SN,NYSE:SNN), the global medical technology business, today announces study results showing patients treated with just its REGENETEN Bioinductive Implant for partial-thickness rotator cuff...
Late-Breaking Trial Data at TVT Demonstrate Sustained Safety and Performance of WATCHMAN FLX™ Left Atrial Appendage Closure Device
Key findings include: The trial met its secondary effectiveness endpoint – defined as the occurrence of ischemic stroke or systemic embolism over 24 months – with a rate of 3.4% compared to the performance goal of 8.7%.
No patients experienced a device embolization or pericardial effusion requiring cardiac surgery through 24 months.
Retia Medical Reports Multi-Beat Analysis Algorithm New Study Further Confirms Superior Accuracy in Comparison to a Competing Option
The study compared the accuracy of two cardiac output monitors, the Retia Argos and the Edwards Lifesciences FloTrac across 58 patients undergoing off-pump coronary artery bypass surgery, yielding 572 sets of cardiac output measurements from each device.