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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Positive Two-Year Data from the ALPS Registry of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System
The ALPS Registry is a multi-center, retrospective study conducted at centers in Alkmaar, Netherlands; Leipzig, Germany; Paris; and Singapore encompassing 32 end-stage – or “no-option” – CLTI patients.
PROTECT III Study Shows Placing Impella Prior to High-Risk PCI is Associated with Lower Mortality Compared to Bailout PCI
PROTECT III Study data presented is from an adjunct study of PROTECT III, the ongoing, prospective FDA post-approval study for Impella in high-risk PCI.
Rabin Medical Center Announced They Will Initiate Clinical Trials to Test Feasibility of Exero Medical’s Wireless Anastomotic Sensor
Researchers at Rabin Medical Center will use Exero’s system to collect data from the sensor during low anterior resection surgery. The results of the trial will enable the company to refine its detection algorithms based on real-life data.
Balt Begin the STEM Trial: Receives IDE Approval From the FDA
The clinical trial is a prospective, randomized controlled trial.
Publication of TOBA III Clinical Trial Results in the Journal of Vascular Surgery
TOBA III Clinical Trial: “We are thrilled to have the TOBA III data published in the Journal of Vascular Surgery,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “This peer-reviewed article adds to the strong body of evidence supporting use of the Tack Endovascular System for focal dissection repair when treating lesions both above- and below-the-knee.”
New Data Unveiled at Heart Rhythm 2020 Demonstrate Effectiveness of App-Based Remote Monitoring of Medtronic Cardiac Devices, Significant Reduction in Complications with Micra Leadless...
During the current COVID-19 pandemic, procedures, and therapies that reduce exposure to other people are important because that also reduces the potential for spreading the virus. The results were presented at the annual Heart Rhythm Society Scientific Sessions, held virtually for the first time.
PINNACLE FLX Study of the WATCHMAN FLX™ Left Atrial Appendage Closure Device Presented as Late-Breaking Clinical Trial at HRS 2020 SCIENCE
PINNACLE FLX clinical trial assesses the safety and efficacy of the next-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for patients with non-valvular atrial fibrillation
SERF VT Study Presented as Part of HRS 2020 Science Late-Breaking Clinical Trial Sessions
The SERF VT Study is underway in the U.S. at Mayo Clinic, Loyola University Medical Center, and Vanderbilt University Medical Center, and in Canada at Southlake Regional Health Centre, Montreal Heart Institute and Quebec Heart and Lung Institute.
Key Recruitment Milestones in ProActive Study and Success in Prospera Early Access Program Reports Natera
ProActive Study will follow 3,000 kidney transplant patients over a three to five year period to examine the utility of the Prospera donor-derived cell-free DNA (dd-cfDNA) transplant assessment test to accurately identify organ rejection.