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borderline medical devices

Victoria L Tseng, Janet Lee, Fei Yu, Omar Sirsy, Anne L Coleman
INTRODUCTION: Previous studies have suggested associations between glaucoma and serum sensitization to specific allergens. The purpose of this study was to examine associations between inciting factors for atopic disease, atopic diseases and symptoms, and glaucoma in the 2005-2006 National Health and Nutrition Examination Survey. METHODS: The study population included adult participants of National Health and Nutrition Examination Survey 2005-2006. Inciting factors for atopic disease included pet ownership, mildew/musty smell in home, cockroaches in home, use of water treatment devices, and crowded living conditions...
May 1, 2018: European Journal of Ophthalmology
Alexander Herner, Bernhard Haller, Ulrich Mayr, Sebastian Rasch, Lea Offman, Roland Schmid, Wolfgang Huber
INTRODUCTION: Central-venous oxygen saturation (ScvO2) is a key parameter of hemodynamic monitoring and has been suggested as therapeutic goal for resuscitation. Several devices offer continuous monitoring features. The CeVOX-device (Pulsion Medical Systems) uses a fibre-optic probe inserted through a conventional central-venous catheter (CVC) to obtain continuous ScvO2. OBJECTIVES: Since there is a lack of studies validating the CeVOX, we prospectively analyzed data from 24 patients with CeVOX-monitoring...
2018: PloS One
Clare Barnett, Sabine Moehner, Thai Do Minh, Klaas Heinemann
OBJECTIVES: The objective of this analysis was to identify intra-uterine devices (IUD) perforations detected from 12 to 60 months following IUD insertion, and to combine this information with (our previously published) data about perforations detected in the first 12 months to calculate cumulative perforation rates. METHODS AND MATERIALS: Prospective, non-interventional cohort study with new users of levonorgestrel-releasing intra-uterine systems (LNG-IUS) and copper-IUD...
December 2017: European Journal of Contraception & Reproductive Health Care
Miri Sklair-Levy, Shlomi Rayman, Ady Yosepovich, Andrew Zbar, David Goitein, Douglas Zippel
The aim of this paper is to evaluate our Unit's initial experience using the Intact breast lesion excision system as a therapeutic excision option for benign or borderline breast lesions, which otherwise would entail open operative excision. The study includes the first 111 patients who underwent therapeutic excision with the intact radiofrequency system between December 2012 and May 2016 performed at the Meirav Center for Breast Health, at the Chaim Sheba Medical Center, Ramat Gan Israel. The indications for the procedure included those patients who have benign, or atypical high risk lesions following a previous core needle biospy (CNB) who would have normally undergone conventional excision biopsy...
October 11, 2017: Breast Journal
Jayant S Vaidya, Frederik Wenz, Max Bulsara, Jeffrey S Tobias, David J Joseph, Christobel Saunders, Chris Brew-Graves, Ingrid Potyka, Stephen Morris, Hrisheekesh J Vaidya, Norman R Williams, Michael Baum
BACKGROUND: Based on our laboratory work and clinical trials we hypothesised that radiotherapy after lumpectomy for breast cancer could be restricted to the tumour bed. In collaboration with the industry we developed a new radiotherapy device and a new surgical operation for delivering single-dose radiation to the tumour bed - the tissues at highest risk of local recurrence. We named it TARGeted Intraoperative radioTherapy (TARGIT). From 1998 we confirmed its feasibility and safety in pilot studies...
September 2016: Health Technology Assessment: HTA
Shaina M Lynch, George Y Wu
A 21 year old female with a past medical history significant for borderline personality disorder and multiple foreign body ingestions, presented to the emergency department from a psychiatric unit after she intentionally ingested a ball point pen. She was found to be hemodynamically stable with a benign abdominal exam. An abdominal x-ray showed a pen lodged in the stomach. Using a novel dual snare technique, the foreign body was removed rapidly and safely in its entirety using a regular single-channel esophagogastroduodenoscope...
January 4, 2016: Journal of Digestive Diseases
Zainab Samad, Linda K Shaw, Matthew Phelan, Mads Ersboll, Niels Risum, Hussein R Al-Khalidi, Donald D Glower, Carmelo A Milano, John H Alexander, Christopher M O'Connor, Andrew Wang, Eric J Velazquez
AIMS: The management and outcomes of patients with functional moderate/severe mitral regurgitation and severe left ventricular (LV) systolic dysfunction are not well defined. We sought to determine the characteristics, management strategies, and outcomes of patients with moderate or severe mitral regurgitation (MR) and LV systolic dysfunction. METHODS AND RESULTS: For the period 1995-2010, the Duke Echocardiography Laboratory and Duke Databank for Cardiovascular Diseases databases were merged to identify patients with moderate or severe functional MR and severe LV dysfunction (defined as LV ejection fraction ≤ 30% or LV end-systolic diameter > 55 mm)...
October 21, 2015: European Heart Journal
Florian Pfanner, Thomas Allmendinger, Birgit Bohn, Thomas Flohr, Marc Kachelrieß
PURPOSE: To avoid motion artifacts, medical imaging devices are often synchronized with the patient's cardiac motion. Today, the ECG is used to determine the heartbeat and therewith trigger the imaging device. However, the ECG requires additional effort to prepare the patient, e.g., mount and wire electrodes and it is not able to determine the motion of the heart. An interesting alternative to assess the cardiac motion is continuous wave radar. The aim of this work is to evaluate such a radar system focusing on measuring the cardiac motion...
August 2014: Medical Physics
Jacob M Larsen, Jens C Nielsen, Jens B Johansen, Jens Haarbo, Helen H Petersen, Anna M Thøgersen, Søren P Hjortshøj
BACKGROUND: Recalled St. Jude Medical Riata defibrillator leads are prone to insulation failures with externalized conductors (ECs). Longitudinal studies are needed to guide lead management. OBJECTIVE: The purpose of this study was to describe the dynamic nature of EC and the association with electrical abnormalities and lead extraction outcomes. METHODS: A nationwide cohort established in 2012 of 295 patients with recalled Riata leads with dwell time 5...
December 2014: Heart Rhythm: the Official Journal of the Heart Rhythm Society
Walter W Eckman, Lynda Hester, Michelle McMillen
BACKGROUND: The versatility of transforaminal lumbar interbody fusion (TLIF) allows fusion at any level along with any necessary canal decompression. Unilateral TLIF with a single interbody device and unilateral pedicle fixation has proven effective, and minimally invasive techniques have shortened hospital stays. Reasonable questions have been raised, though, about whether same-day discharge is feasible and safe after TLIF surgery. QUESTIONS/PURPOSES: We determined, in a high-volume spine practice, what proportion of patients having one- or two-level minimally invasive unilateral TLIF go home on the day of surgery or stay longer and compared the two groups in terms of outcome scores (VAS scores for back and leg pain, Waddell-Main Disability Index), complications, and hospital readmissions...
June 2014: Clinical Orthopaedics and related Research
Florian Pfanner, Joscha Maier, Thomas Allmendinger, Thomas Flohr, Marc Kachelrieß
PURPOSE: To avoid motion artifacts in medical imaging or to minimize the exposure of healthy tissues in radiation therapy, medical devices are often synchronized with the patient's respiratory motion. Today's respiratory motion monitors require additional effort to prepare the patients, e.g., mounting a motion belt or placing an optical reflector on the patient's breast. Furthermore, they are not able to measure internal organ motion without implanting markers. An interesting alternative to assess the patient's organ motion is continuous wave radar...
September 2013: Medical Physics
Pablo Rengifo-Moreno, Igor F Palacios, Parichart Junpaparp, Christian F Witzke, D Lynn Morris, Abel Romero-Corral
BACKGROUND: In patients with cryptogenic stroke, transcatheter (TC) closure of a patent foramen ovale (PFO) has not been shown to better prevent recurrent vascular events than medical therapy. However, randomized controlled trials (RCT) to date have included few vascular events, and lack of power has been raised as an important concern. OBJECTIVE: To conduct a systematic review and meta-analysis of existing RCT published studies assessing the recurrence of vascular events after TC PFO closure when compared to medical therapy...
November 2013: European Heart Journal
Mathias Wolfrum, Georg M Froehlich, Guido Knapp, Leanne K Casaubon, James J DiNicolantonio, Alexandra J Lansky, Pascal Meier
CONTEXT: The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence. OBJECTIVE: Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptogenic strokes as compared to best medical therapy (BMT). DATA SOURCES: Trials were identified through a literature search until 28 May 2013. STUDY SELECTION: Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT...
March 2014: Heart: Official Journal of the British Cardiac Society
Maria Rosa Costanzo, Russell J Ivanhoe, Andrew Kao, Inder S Anand, Alan Bank, John Boehmer, Teresa Demarco, Cheryl M Hergert, Richard G Holcomb, Simon Maybaum, Benjamin Sun, Thomas A Vassiliades, Barry K Rayburn, William T Abraham
BACKGROUND: Left ventricular (LV) remodeling predicts poor outcomes in heart failure (HF) patients. The HeartNet(®) cardiac restraint device (Paracor Medical Inc., Sunnyvale, CA) may reduce LV remodeling and improve functional capacity, quality of life, and outcomes in HF patients. To evaluate the safety and efficacy of the HeartNet Ventricular Support System in HF patients receiving optimal medical therapy. METHODS AND RESULTS: Prospective, randomized, controlled, multicenter trial in patients with symptomatic HF and LV ejection fraction ≤35% on optimal medical and device therapy...
June 2012: Journal of Cardiac Failure
Efstratios Georgakarakos, George S Georgiadis, Evagelos Nikolopoulos, George Trellopoulos, Konstantinos Kapoulas, Miltos Lazarides
The idea of early endovascular aortic repair (EVAR) of "small" abdominal aortic aneurysms (AAAs) has gained attention over "watchful waiting," mostly due to the concern for losing the anatomic suitability for endovascular repair over time. Generally, small AAAs have longer, smaller, less angulated necks, and less tortuous iliac arteries than larger ones. Though the borderline anatomic characteristics were assumed to be contraindications for older generation endografts, the modifications of modern devices seem promising to overcome those limitations, in order to treat the small AAAs when reaching the 5...
July 2012: Vascular and Endovascular Surgery
Dominic J Autelitano, Linda Raineri, Kate Knight, Kelly Bannister, Gregory E Rice
BACKGROUND: Concomitant with the development of in vitro diagnostic multivariate index assays (IVDMIAs) to improve the diagnostic efficiency of ovarian cancer detection is the need to identify appropriate biostatistical approaches to assess improvements in risk predication. In this study, we assessed the utility of three different approaches for comparing diagnostic efficiency of an ovarian cancer multivariate assay in a retrospective case--control phase 2 biomarker trial. The control cohort included both disease-free women and women with benign gynecological conditions to more accurately reflect the target population of symptomatic women...
2012: Journal of Translational Medicine
Victor Ryzhii
The terahertz (THz) range of frequencies is borderline between microwave electronics and photonics. It corresponds to the frequency bands of molecular and lattice vibrations in gases, fluids, and solids. The importance of the THz range is in part due to numerous potential and emerging applications which include imaging and characterization, detection of hazardous substances, environmental monitoring, radio astronomy, covert inter-satellite communications, as well as biological and medical applications. During the last decades marked progress has been achieved in the development, fabrication, and practical implementation of THz devices and systems...
August 19, 2008: Journal of Physics. Condensed Matter: An Institute of Physics Journal
Woo-Chul Kim, Ji-Eun Lee, Yong-Soon Kwon, Yu-Jin Koo, In-Ho Lee, Kyung-Taek Lim
OBJECTIVE: In this article, we present our initial experience with laparoendoscopic single-site surgery (LESS) for adnexal tumors and report on the safety and feasibility of this technique. STUDY DESIGN: We retrospectively reviewed the medical records of the first 94 consecutive patients who underwent LESS for adnexal tumors at Cheil General Hospital and Women's Healthcare Center, Seoul, Korea between March 2009 and July 2010. Our retrospective chart review was approved by our local Institutional Review Board (IRB)...
October 2011: European Journal of Obstetrics, Gynecology, and Reproductive Biology
Amine El Helou, Sylvie Bastuji-Garin, Elena Paillaud, Jean-Michel Gracies, Wafa Skalli, Philippe Decq
OBJECTIVES: This study aimed at assessing the profile of ambulation aid users among patients admitted for geriatric rehabilitation care. DESIGN: Retrospective chart review. SETTING: Geriatric Rehabilitation Department of the Hôpital Albert Chenevier, Créteil, France. PARTICIPANTS: The sample comprised 206 records of patients aged 65 or older with no previous use of assistive device before admission and length of stay longer than 7 days...
March 2012: Journal of the American Medical Directors Association
Fabio Verzini, Paola De Rango, Gianbattista Parlani, Giuseppe Giordano, Valeria Caso, Enrico Cieri, Giacomo Isernia, Piergiorgio Cao
OBJECTIVES: Increasing data suggest that statins can significantly decrease cardiovascular and cerebrovascular events due to a plaque stabilization effect. However, the benefit of statins in patients undergoing carotid angioplasty and stenting (CAS) for carotid stenosis is not well defined. The aim of this study was to investigate whether statins use was associated with decreased perioperative and late risks of stroke, mortality, and restenosis in patients undergoing CAS. METHODS: All patients undergoing CAS for primary carotid stenosis from 2004 to 2009 were reviewed...
January 2011: Journal of Vascular Surgery
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