PubMed Journals Articles About "[Trial Of Device That Is Not Approved Or Cleared By The U.S. FDA]" RSS

00:39 EST 17th February 2019 | BioPortfolio

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Showing "Trial device that approved cleared" PubMed Articles 1–25 of 7,800+

Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.

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.

An Analysis of Foot and Ankle Device Recalls by the Food and Drug Administration.

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...

Multicenter Assessment of Grafts in Coronaries: Midterm Evaluation of the C-Port Device (the MAGIC Study).

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.

Edoxaban and implantable cardiac device interventions: insights from the ENGAGE AF-TIMI 48 trial.

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.

Evaluation of Wearable Digital Devices in a Phase I Clinical 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...

Exclusive clinical experience with a lower profile device for resuscitative endovascular balloon occlusion of the aorta (REBOA).

A lower profile, FDA-approved device for aortic occlusion (AO) is available for REBOA.

Device Approved to Seal Coronary Artery Perforations.

A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device.

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.

Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.

To investigate whether a 20-cc buffered 1% lidocaine paracervical block decreases pain during intrauterine device (IUD) placement.

Can smartphone wireless ECGs be used to accurately assess ECG intervals in pediatrics? A comparison of mobile health monitoring to standard 12-lead ECG.

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.

Analysis of Reported Adverse Events with Uterine Artery Embolization for Leiomyomas.

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.

Continued vs. interrupted direct oral anticoagulants at the time of device surgery, in patients with moderate to high risk of arterial thrombo-embolic events (BRUISE CONTROL-2).

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...

Nuances of carotid artery stenting under flow arrest with dual-balloon guide catheter.

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...

Clinical Device Trial Opportunities for HTM Professionals.

First Successful Mechanical Splint for Obstructive Sleep Apnea With an Orally Administrable Pharyngeal Stenting Device.

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...

A Review of Blood Glucose Monitor Accuracy.

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 ...

How representative are insomnia clinical trials?

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.

Feasibility of data linkage in the PARAMEDIC trial: a cluster randomised trial of mechanical chest compression in out-of-hospital cardiac arrest.

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...

Outcome of a High Frequency Transcutaneous Electrical Nerve Stimulator (hfTENS) Device for Low Back Pain: A Randomized Controlled Trial.

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...

Pipeline embolization device treatment of internal carotid artery terminus aneurysms.

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.

Urinary Excretion of Homocysteine Thiolactone and the Risk of Acute Myocardial Infarction in Coronary Artery Disease Patients; the WENBIT Trial.

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.

Pipeline embolization device with Shield technology for intracranial aneurysms: An initial United States experience.

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.

Changes in the Sagittal Cranio-Cervical Posture Following a 12-Week Intervention Using a Simple Spinal Traction Device.

Non-controlled clinical trial OBJECTIVE.: To assess the efficacy of a simple home spinal traction device on sagittal cranio-cervical posture and related symptoms.

Left Atrial Appendage Closure Device Implantation in Patients with Prior Intracranial Hemorrhage.

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.

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