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Mesh medical device

Jason M Sandberg, Ian Gray, Amy Pearlman, Ryan P Terlecki
Purpose: To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States. Materials and Methods: We reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event...
March 2018: Investigative and Clinical Urology
G Brun, H Verdoux, G Couhet, C Quiles
OBJECTIVES: Video games and virtual reality have recently become used by clinicians for training or information media or as therapeutic tools. The purpose is to review the use of these technologies for therapy destined for schizophrenia patients. METHODS: We conducted a review in October 2016 using Pubmed, Scopus and PsychInfo using the following Medical Subject Headings (MESH): "video games", "virtual reality" and "therapy, computer-assisted/methods", each associated with "schizophrenia"...
February 28, 2018: L'Encéphale
Wei Li, Xiaoxue Xu, Wenjiang Li, Yun Zhao, Minfang Chen
A novel, cost-effective biomedical triboelectric nanogenerator (TENG) has been fabricated based on biocompatible medical 317L stainless steel (317L SS) and polylactic acid (PLLA) films as the friction layers, whose surface roughness designed by simple and low-cost laser etching and hot-embossing template methods, respectively. With the increase of the TENG's tribo-interface roughness and the molecular weight of the PLLA, the power output of TENG was greatly increased owing to more charges produced and excellent mechanical properties of PLLA possessed...
February 27, 2018: Nanotechnology
Emanuel Clauss-Lendzian, Ankita Vaishampayan, Anne de Jong, Uwe Landau, Carsten Meyer, Jan Kok, Elisabeth Grohmann
Emerging antibiotic resistance among pathogenic bacteria, paired with their ability to form biofilms on medical and technical devices, represents a serious problem for effective and long-term decontamination in health-care environments and gives rise to an urgent need for new antimicrobial materials. Here we present the impact of AGXX® , a novel broad-spectrum antimicrobial surface coating consisting of micro-galvanic elements formed by silver and ruthenium, on the transcriptome of Enterococcus faecalis. A clinical E...
March 2018: Microbiological Research
Martin Koller
Polyhydroxyalkanoates (PHA) are bio-based microbial biopolyesters; their stiffness, elasticity, crystallinity and degradability are tunable by the monomeric composition, selection of microbial production strain, substrates, process parameters during production, and post-synthetic processing; they display biological alternatives for diverse technomers of petrochemical origin. This, together with the fact that their monomeric and oligomeric in vivo degradation products do not exert any toxic or elsewhere negative effect to living cells or tissue of humans or animals, makes them highly stimulating for various applications in the medical field...
February 8, 2018: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
Xiaochuan Dai, Guosong Hong, Teng Gao, Charles M Lieber
Nanobioelectronics represents a rapidly developing field with broad-ranging opportunities in fundamental biological sciences, biotechnology, and medicine. Despite this potential, seamless integration of electronics has been difficult due to fundamental mismatches, including size and mechanical properties, between the elements of the electronic and living biological systems. In this Account, we discuss the concept, development, key demonstrations, and future opportunities of mesh nanoelectronics as a general paradigm for seamless integration of electronics within synthetic tissues and live animals...
January 30, 2018: Accounts of Chemical Research
Hongzhi Lan, Adam Updegrove, Nathan Wilson, Gabriel D Maher, Shawn C Shadden, Alison Marsden
Patient-specific simulation plays an important role in cardiovascular disease research, diagnosis, surgical planning and medical device design, as well as education in cardiovascular biomechanics. SimVascular is an open-source software package encompassing an entire cardiovascular modeling and simulation pipeline from image segmentation, 3D solid modeling, and mesh generation, to patient-specific simulation and analysis. SimVascular is widely used for cardiovascular basic science and clinical research as well as education, following increased adoption by users and development of a GATEWAY web portal to facilitate educational access...
December 13, 2017: Journal of Biomechanical Engineering
Yoshifumi Nakajima, Saibal Kar
The MitraClip (Abbott Vascular, Santa Clara, CA) procedure has emerged as a safe and effective treatment option for treatment of selected patients with severe mitral regurgitation (MR) who are at high risk for surgery. Effective reduction of MR is important to ensure an optimal clinical outcome. We present here the first case report of a significant commissural leak after a MitraClip procedure treated with a GORE CARDIOFORM Septal Occluder device (WL Gore & Associates, Flagstaff, AZ). CASE REPORT: An 81-year-old male presented with symptomatic recurrent MR following a MitraClip procedure using two clips...
December 8, 2017: Catheterization and Cardiovascular Interventions
Robert B Dunne, Sandra Shortt
INTRODUCTION: Projects comparing bronchodilator response by aerosol devices in the ED are limited. Evidence suggests that the vibrating mesh nebulizer (VMN) provides 5-fold greater aerosol delivery to the lung as compared to a jet nebulizer (JN). The aim of this project was to evaluate a new nebulizer deployed in an Emergency Department. METHODS: A quality improvement evaluation using a prospectively identified data set from the electronic medical record comparing all ED patients receiving aerosolized bronchodilators with the JN during September 2015 to those receiving aerosolized bronchodilators with the VMN during October 2015...
October 31, 2017: American Journal of Emergency Medicine
Lindsey G Kahan, Jeffrey A Blatnik
BACKGROUND: With an array of hernia meshes with varying properties, intraoperative decision making for the optimal mesh is critical. While meshes are subjected to regulatory review through the FDA, it is unknown whether mesh properties are visually accessible. To facilitate greater knowledge for the surgeon on mesh choice, we aimed to comprehensively analyze hernia mesh packaging and regulations. STUDY DESIGN: Labeling guidelines and 510(k) requirements across FDA-regulated products were analyzed and compared to mesh packaging...
November 10, 2017: Journal of the American College of Surgeons
Peter M Vogt, Joerg Hauser, Stefan Mueller, Bjoern Bosse, Michael Hopp
INTRODUCTION: Infection is a major threat to wound healing and a leading cause of graft loss in patients undergoing meshed skin grafts (MSGs). Therefore, topical antisepsis is important in the overall treatment scheme. METHODS: An exploratory satellite group of 14 patients with infected MSGs were enrolled as part of a prospective, randomized, controlled, parallel-group, open-label, pilot Phase II study that investigated the efficacy and tolerability of 3% liposomal povidone-iodine hydrogel (PVP-ILH, Repithel® ; RepiGel® ) versus chlorhexidine gauze in non-infected MSGs...
December 2017: Infectious Diseases and Therapy
Islam O F Moustafa, Mohammed R A-A Ali, Moataz Al Hallag, Hoda Rabea, James B Fink, Patricia Dailey, Mohamed E A Abdelrahim
BACKGROUND: During mechanical ventilation medical aerosol delivery has been reported to be upto two fold greater with dry inhaled gas than with heated humidity. Urine levels at 0.5 h post dose (URSAL0.5%) has been confirmed as an index of lung deposition and 24 h (URSAL24%) as index of systemic absorption. Our aim was to determine the effect of humidification and aerosol device type on drug delivery to ventilated patients using urine levels. METHODS: In a randomized crossover design, 36 (18female) mechanically ventilated patients were assigned to one of three groups...
November 2017: Heart & Lung: the Journal of Critical Care
H Bougard, C Doerhoff, S Bringman, M Chudy, C Romanowski, P Jones
BACKGROUND: Surgeons utilise various mesh fixation methods during hernia repair which may include tacks/straps and/or sutures. One of these tack/strap choices, is an absorbable fixation device, Securestrap® (ETHICON, Somerville, NJ), consisting of polydioxanone and L (-)-lactide/glycolide copolymer. The 6 month clinical results and patient outcomes with Securestrap® fixation are reported. METHOD: The International Hernia Mesh Registry, prospective multi-centre registry, designed to collect patient reported, longitudinal data on hernia mesh products and fixation methods...
September 2017: South African Journal of Surgery. Suid-Afrikaanse Tydskrif Vir Chirurgie
M W V Ng, K C Ng
PURPOSE: Laparoscopic hernioplasty has been gaining its popularity in the past decade for its rapid recovery. Single-incision surgery, as its possible advancement, has also received more attention. Traditional laparoscopic surgery with carbon dioxide insufflation precluded patients with underlying cardiovascular or pulmonary disease from minimal invasive surgery. We report our early experience with gasless single-incision laparoscopic inguinal hernia repair via totally extraperitoneal (TEP) approach...
October 2017: Hernia: the Journal of Hernias and Abdominal Wall Surgery
Karthik Tappa, Udayabhanu Jammalamadaka, David H Ballard, Todd Bruno, Marissa R Israel, Harika Vemula, J Mark Meacham, David K Mills, Pamela K Woodard, Jeffery A Weisman
3D printing has the potential to deliver personalized implants and devices for obstetric and gynecologic applications. The aim of this study is to engineer customizable and biodegradable 3D printed implant materials that can elute estrogen and/or progesterone. All 3D constructs were printed using polycaprolactone (PCL) biodegradable polymer laden with estrogen or progesterone and were subjected to hormone-release profile studies using ELISA kits. Material thermal properties were tested using thermogravimetric analysis and differential scanning calorimetry...
2017: PloS One
Nasser Sakran, Hadar Nevo, Ron Dar, Asnat Raziel, Dan Hershko
Upside-down stomach is a relatively rare type of a large paraesophageal hernia characterized by the migration of the stomach into the posterior mediastinum. Upside-down stomach is prone to severe complications and therefore surgery is recommended even in asymptomatic patients. A 62-year-old male presented with frequent abdominal pain with nausea and vomiting that persisted for one year. The patient was obese with fatty liver and was treated medically for gastroesophageal reflux disease (GERD) for 4 years. On upper gastrointestinal CT study a level-IV paraesophageal hernia was detected with upside-down stomach, and he was referred for elective surgery...
2017: Case Reports in Surgery
Arjun Nambiar, June D Cody, Stephen T Jeffery, Patricia Aluko
BACKGROUND: Urinary incontinence has been shown to affect up to 50% of women. Studies in the USA have shown that up to 80% of these women have an element of stress urinary incontinence. This imposes significant health and economic burden on society and the women affected. Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formation...
July 26, 2017: Cochrane Database of Systematic Reviews
O V Galimov, V O Khanov, D Z Mamadaliev, R R Sayfullin, R R Sagitdinov
AIM: To present an experience of surgical treatment of hiatal hernia. MATERIAL AND METHODS: An experience of more than thousand laparoscopic fundoplications in various modifications has been accumulated in the Clinic of Bashkir State Medical University for the period 2001-2016. RESULTS: An original device for intraoperative measurement of hiatal orifice is described. Hiatal orifice repair was indicated in case of its dimension over 3.5 cm...
2017: Khirurgiia
Alessandro Peretti, Francesco Amenta, Seyed Khosrow Tayebati, Giulio Nittari, Syed Sarosh Mahdi
BACKGROUND: Telemedicine applications have been increasing due to the development of new computer science technologies and of more advanced telemedical devices. Various types of telerehabilitation treatments and their relative intensities and duration have been reported. OBJECTIVE: The objective of this review is to provide a detailed overview of the rehabilitation techniques for remote sites (telerehabilitation) and their fields of application, with analysis of the benefits and the drawbacks related to use...
July 21, 2017: JMIR Rehabilitation and Assistive Technologies
Muhammad H E ElHansy, Marina E Boules, Assem Fouad Mohamed El Essawy, Mohamed Bakry Al-Kholy, Maha M Abdelrahman, Amira S A Said, Raghda R S Hussein, Mohamed E Abdelrahim
BACKGROUND: Patient receiving invasive mechanical ventilation (IMV) may benefit from medical aerosol, but guidance on dosing with different aerosol devices is limited to in-vitro studies. The study was designed to compare aerosol delivery with five different types of aerosol generators during IMV. METHOD: In randomized design, 60 (30 female) mechanically ventilated chronic obstructive pulmonary disease (COPD) patients were assigned to one of 5 groups. Groups 1-4 received 5000 μg salbutamol using Aerogen Pro (PRO), Aerogen Solo (SOLO), NIVO vibrating mesh and jet nebulizers (JN), respectively, while group 5 received 800 μg (8 puffs) of salbutamol via metered dose inhaler with AeroChamber-MV (MDI-AC)...
August 2017: Pulmonary Pharmacology & Therapeutics
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