Search results for "Medical device"
showing 10 items of 47 documents
Ischemic stroke risk during long-term follow up in patients with successful catheter ablation for atrial fibrillation in Korea
2018
The interruption of oral anticoagulation therapy (OAC) after CA of atrial fibrillation (AF) is controversial. The purpose of this study was to evaluate the relationship between successful long-term outcomes of catheter resection and SR maintenance and ischemic stroke risk in Korea. We studied 1,548 consecutive patients who were followed up for more than 2 years after CA of AF. We investigated the incidence of ischemic stroke during long-term follow-up. Compared to the AF recurrence group (n = 619), the sinus rhythm (SR) maintenance group (n = 929) had more paroxysmal AF (74.6% versus 44.4%, p<0.001), smaller LA size (39.9±5.7mm versus 42.3±6.0mm, p<0.001), and younger age (54.2±10.9 years v…
Viscoelastics: Medical Device or Drug
2000
In § 2 of the German Drug Laws (AMG, Arzneimittelgesetz), it is determined that such materials that fall under the heading of medicinal products (MPG, Medizinproduktegesetz, 1994) are not drugs in the AMG sense of the word. MPG medicinal products, as defined in §3 are those substances whose main effect is neither pharmacological, immunological, nor metabolic.
Medial buttressing of the quadrilateral surface in acetabular and periprosthetic acetabular fractures
2020
Background In geriatric acetabular fractures, the quadrilateral plate is often involved in the fracture pattern and medially displaced. Open reduction and internal fixation (ORIF) includes reduction of the quadrilateral plate and securing its position. In this study, the concept of medial buttressing in acute and periprosthetic acetabular fractures is evaluated. Materials and methods Patients, who sustained an acetabular fracture between 2012 and 2018, in whom ORIF with a specific implant for medial buttressing was performed, were included in the study. Patients were divided in two groups; acute acetabular fractures (group 1) and periprosthetic acetabular fractures (group 2). Demographics,…
Impact of Pre-Analytical Time on the Recovery of Pathogens from Blood Cultures: Results from a Large Retrospective Survey.
2017
Background Prompt identification of bloodstream pathogens is essential for optimal management of patients. Significant changes in analytical methods have improved the turnaround time for laboratory diagnosis. Less attention has been paid to the time elapsing from blood collection to incubation and to its potential effect on recovery of pathogens. We evaluated the performance of blood cultures collected under typical hospital conditions in relation to the length of their pre-analytical time. Methods We carried out a large retrospective study including 50,955 blood cultures collected, over a 30-month period, from 7,035 adult septic patients. Cultures were accepted by the laboratory only durin…
Multi frequency phase fluorimetry (MFPF) for oxygen partial pressure measurement: ex vivo validation by polarographic clark-type electrode.
2013
BACKGROUND: Measurement of partial pressure of oxygen (PO2) at high temporal resolution remains a technological challenge. This study introduces a novel PO2 sensing technology based on Multi-Frequency Phase Fluorimetry (MFPF). The aim was to validate MFPF against polarographic Clark-type electrode (CTE) PO2 measurements. METHODOLOGY/PRINCIPAL FINDINGS: MFPF technology was first investigated in N = 8 anaesthetised pigs at FIO2 of 0.21, 0.4, 0.6, 0.8 and 1.0. At each FIO2 level, blood samples were withdrawn and PO2 was measured in vitro with MFPF using two FOXY-AL300 probes immediately followed by CTE measurement. Secondly, MFPF-PO2 readings were compared to CTE in an artificial circulatory s…
Additive Manufacturing of Multi‐Scale Porous Soft Tissue Implants That Encourage Vascularization and Tissue Ingrowth
2021
Medical devices, such as silicone-based prostheses designed for soft tissue implantation, often induce a suboptimal foreign-body response which results in a hardened avascular fibrotic capsule around the device, often leading to patient discomfort or implant failure. Here, it is proposed that additive manufacturing techniques can be used to deposit durable coatings with multiscale porosity on soft tissue implant surfaces to promote optimal tissue integration. Specifically, the “liquid rope coil effect”, is exploited via direct ink writing, to create a controlled macro open-pore architecture, including over highly curved surfaces, while adapting atomizing spray deposition of a silicone ink t…
Protective and regenerative effects of a novel medical device against esophageal mucosal damage using in vitro and ex vivo models.
2020
Gastroesophageal reflux disease (GERD) is a common digestive disorder that causes esophagitis and injuries to the esophageal mucosa. GERD symptoms are recurrent during pregnancy and their treatment is focused on lifestyle changes and nonprescription medicines. The aim of this study was to characterize the mechanism of action of a new patented medical device, an oral formulation containing hyaluronic acid, rice extract, and amino acids dispersed in a bioadhesive polymer matrix, by assessing its protective effects in in vitro and ex vivo models of esophageal mucosa damage. Acidic bile salts and pepsin cocktail (BSC) added to CP-A and COLO-680 N esophagus cells were used as an in vitro GERD mo…
Beneficial Effect of Foot Plantar Stimulation in Gait Parameters in Individuals with Parkinson’s Disease
2020
New treatments based on peripheral stimulation of the sensory-motor system have shown to be promising in rehabilitation strategies for patients with neurological disorders, including Parkinson's disease (PD), especially in regards to reducing gait impairment, and hence, the incidence of falls. The aim of this study was to evaluate the change in several gait parameters measured by sensor inertial measurement in PD patients after acute plantar stimulation, under the distal phalanx of the big toe, and underneath the head of the first metatarsal joint of both feet, using a 3D printing insole. In order to assess whether the effects are selective for PD patients, we compared the effect of the tre…
Comparison of 2 Zero-Profile Implants in the Treatment of Single-Level Cervical Spondylotic Myelopathy: A Preliminary Clinical Study of Cervical Disc…
2016
Objectives Cervical disc arthroplasty (CDA) with Discover prosthesis or anterior cervical discectomy and fusion (ACDF) with Zero-P cage has been widely used in the treatment of cervical spondylotic myelopathy (CSM). However, little is known about the comparison of the 2 zero-profile implants in the treatment of single-level CSM. The aim was to compare the clinical outcomes and radiographic parameters of CDA with Discover prosthesis and ACDF with Zero-P cage for the treatment of single-level CSM. Methods A total of 128 consecutive patients who underwent 1-level CDA with Discover prosthesis or ACDF with Zero-P cage for single-level CSM between September 2009 and December 2012 were included in…
Mobility Modification Alleviates Environmental Influence on Incident Mobility Difficulty among Community-Dwelling Older People: A Two-Year Follow-Up …
2016
Background Environmental barriers increase risk for mobility difficulties in old age. Mobility difficulty is preceded by a phase where people try to postpone a difficulty through mobility modification. We studied whether perceived environmental mobility barriers outdoors correlate with mobility modification and mobility difficulty, predict development of mobility difficulty over a two-year follow-up, and whether mobility modification alleviates the risk for difficulty. Methods At baseline, 848 people aged 75–90 were interviewed face-to-face. Telephone follow-up interviews were conducted one (n = 816) and two years (n = 761) later. Environmental barriers to mobility were self-reported using …