Track topics on Twitter Track topics that are important to you
[Trial Of Device That Is Not Approved Or Cleared By The U.S. FDA] PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest [Trial Of Device That Is Not Approved Or Cleared By The U.S. FDA] articles that have been published worldwide.
We have published hundreds of [Trial Of Device That Is Not Approved Or Cleared By The U.S. FDA] news stories on BioPortfolio along with dozens of [Trial Of Device That Is Not Approved Or Cleared By The U.S. FDA] Clinical Trials and PubMed Articles about [Trial Of Device That Is Not Approved Or Cleared By The U.S. FDA] for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of [Trial Of Device That Is Not Approved Or Cleared By The U.S. FDA] Companies in our database. You can also find out about relevant [Trial Of Device That Is Not Approved Or Cleared By The U.S. FDA] Drugs and Medications on this site too.
We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.
Introduction Orthopaedic devices represent 12% of all medical device recalls. Products are approved through pre-market approval (PMA) or the 510(k) premarket notification process. No previous evaluation was found in the literature evaluating foot and ankle device recalls. The field of foot and ankle subspecialty has seen a rapid growth in innovation related to implants in recent years. Methods The Food and Drug Administration (FDA) Device Recall database was evaluated for all foot and ankle devices from 20...
The commercially available C-Port distal anastomotic device (Food and Drug Administration cleared in 2007) is an automated miniature vascular stapler that performs the coronary anastomosis. This prospective multicenter registry sought to evaluate midterm patency using this device compared with hand-sewn grafts.
Studies indicate that decision making and informed consent among patients considering Left Ventricular Assist Device (LVAD) support for advanced heart failure could be improved. In the VADDA (ventricular assist device decision aid) trial, we tested a patient-centered decision aid (DA) to enhance the quality of decision making about LVAD therapy.
Pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy device implantations and generator changes are frequently performed in patients receiving direct oral anticoagulants. In an exploratory analysis, we investigated the outcome of patients undergoing such device procedures in the ENGAGE AF-TIMI 48 trial.
We assessed the performance of two US Food and Drug Administration (FDA) 510(k)-cleared wearable digital devices and the operational feasibility of deploying them to augment data collection in a 10-day residential phase I clinical trial. The Phillips Actiwatch Spectrum Pro (Actiwatch) was used to assess mobility and sleep, and the Vitalconnect HealthPatch MD (HealthPatch) was used for monitoring heart rate (HR), respiratory rate (RR), and surface skin temperature (ST). We measured data collection rates, com...
A lower profile, FDA-approved device for aortic occlusion (AO) is available for REBOA.
Several studies have compared EUS fine-needle aspiration (FNA) with biopsy (FNB) needles, but none has proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle.
To investigate whether a 20-cc buffered 1% lidocaine paracervical block decreases pain during intrauterine device (IUD) placement.
Arrhythmias in children are often paroxysmal, complicating the ability to capture the abnormal rhythm on routine ECG during an outpatient visit. The Alivecor Kardia Mobile (KM) device is a wireless mobile health (mHealth) device that generates a single lead ECG tracing with a FDA-approved algorithm for detection of atrial fibrillation in adults.
The Manufacturer and User Facility Device Experience (MAUDE) database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with uterine artery embolization used for treatment of fibroids using this database.
Guidelines recommend warfarin continuation rather than heparin bridging for pacemaker and defibrillator surgery, after the BRUISE CONTROL trial demonstrated an 80% reduction in device pocket haematoma with this approach. However, direct oral anticoagulants (DOACs) are now used to treat the majority of patients with atrial fibrillation. We sought to understand the best strategy to manage the DOACs at the time of device surgery and specifically hypothesized that performing device surgery without DOAC interrup...
Cerebral protection device utilization during carotid artery stenting (CAS) has been demonstrated to decrease the risk of perioperative stroke. The ProximAl Protection with the MO.MA Device During CaRotid Stenting (ARMOUR) Trial had the lowest event rates of any independently adjudicated study. In this video of two cases of severe carotid artery stenosis, the authors present the nuances of the CAS procedure utilizing a dual-balloon guide catheter device (MO.MA). This device has the benefit of being in place...
We report the case of obstructive sleep apnea in a 19-year-old, otherwise healthy male presenting with persistent daytime sleepiness and nonrestorative sleep after velo- and uvuloplasty. An individually tailored prototype of an orally inserted pharyngeal stenting device was proposed in the framework of a first clinical feasibility trial. The noninvasive, easily self-administered device is mounted on a simple inferior dental guard. Baseline total apnea-hypopnea index (AHI) was 15.5 and 24.4 per hour of rapid...
The aim of this study was to assess the accuracy of blood glucose monitors (BGMs) from studies reported in the medical literature. A literature review was performed of publications between 2010 and 2017 that presented data about the accuracy of BGMs using ISO 15197 2003 and/or ISO 15197 2013 as target standards. We found 58 publications describing the performance of 143 unique BGM systems, 59 of which were Food and Drug Administration (FDA) cleared. When compared with non-FDA-cleared BGMs, FDA-cleared BGMs ...
To address the question of how representative subjects studied in hypnotic clinical trials are of the broader insomnia population, this study assessed initial contact rates and reasons for inclusion and exclusion during recruitment to an efficacy trial and to a safety trial of Food & Drug Administration (FDA) approved hypnotics.
There is considerable interest in reducing the cost of clinical trials. Linkage of trial data to administrative datasets and disease-specific registries may improve trial efficiency, but it has not been reported in resuscitation trials conducted in the UK. To assess the feasibility of using national administrative and clinical datasets to follow up patients transported to hospital following attempted resuscitation in a cluster randomised trial of a mechanical chest compression device in out-of-hospital card...
This controlled trial examined the benefit of a high-frequency transcutaneous electrical nerve stimulation (hfTENS) device (Quell ) for chronic low back pain (CLBP) patients. Thirty-five (N=35) participants were randomly assigned to use the device each day for 3 months (Experimental) and were compared with 33 subjects without the device (treatment-as-usual Control). All patients were instructed to complete baseline questionnaires and were assessed on thresholds of pressure pain and mechanical temporal summa...
The pipeline embolization device (PED) is approved for the treatment of large aneurysms of the proximal internal carotid artery (ICA). Its off-label application in treating aneurysms located specifically at the ICA terminus (ICA-T) has not been studied.
No individual homocysteine (Hcy) metabolite has been studied as a risk marker for coronary artery disease (CAD). Our objective was to examine Hcy-thiolactone, a chemically reactive metabolite generated by methionyl-tRNA synthetase and cleared by the kidney, as a risk predictor of incident acute myocardial infarction (AMI) in the Western Norway B-Vitamin Intervention Trial.
Thromboembolic complications remain a major reason for morbidity and mortality after flow diversion along with hemorrhagic complications not limited to the brain predicated on the prolonged need for dual antiplatelet therapy. Surface modification to decrease thrombogenicity and accelerate aneurysm occlusion is a promising alteration to mitigate those risks. The Pipeline embolization device (PED) with Shield technology possesses such characteristics, but is currently not approved in the United States.
Non-controlled clinical trial OBJECTIVE.: To assess the efficacy of a simple home spinal traction device on sagittal cranio-cervical posture and related symptoms.
The Watchman™ device (Boston Scientific, MN), used for left atrial appendage closure (LAAC) was approved for stroke prevention in patients with atrial fibrillation (AF) and an appropriate rationale to avoid long-term oral anticoagulation. Patients with AF and prior intracranial hemorrhage (ICH) were excluded from clinical trials due to perceived risks of peri-operative anticoagulation.