Day 2 :
- Track 4: Advanced Technologies in Medical Devices
Track 5: Medical Devices for Home Use
Track 6: Hospital Equipment Business and Market
Location: Hyatt Regency Orlando International Airport
Ion Beam Applications, Belgium
Decision Resources Group, Canada
Alexandre Caixeta Guimaraes
University of Campinas, Brazil
Title: Hearing preservation and cochlear implants according to inner ear approach: Multicentric evaluation
Alexandre Caixeta Guimaraes, M.D., graduated in 2009 from the University of Campinas (UNICAMP), Brazil, received his title of specialist in otolaryngology from UNICAMP and concluded his fellowship in neurotology and otological surgery from UNICAMP. He is currently concluding his Ph.D. in medical sciences at UNICAMP, is a member of the Division of Otolaryngology Head and Neck Surgery at the University of Campinas, has published more than 45 papers in reputable journals and has been serving as an editorial board member and reviewer of several international journals.
Introduction: Electroacoustic stimulation is an excellent option for people with residual hearing in the low frequencies, who obtain insufficient benefit with hearing aids. To be effective, the subject’s residual hearing should be preserved during cochlear implant surgery. Objectives: To evaluate the hearing preservation in patients that underwent implant placement and to compare the results in accordance with the approach to the inner ear. Methods: 19 subjects underwent a soft surgical technique, and the electrode MED-EL FLEX™ EAS, designed to be atraumatic, was used. We evaluated pre- and postoperative tonal audiometric tests with an average of 18.4 months after implantation, to measure the rate of hearing preservation. Results: 17 patients had total or partial preservation of residual hearing; 5 had total hearing preservation and two individuals had no preservation of hearing. The insertion of the electrode occurred through a cochleostomy in 3 patients, and in 2 of these there was no hearing preservation; the other 16 patients experienced electrode insertion through a round window approach. All patients benefited from the cochlear implant, even those who are only using electrical stimulation. Conclusion: The hearing preservation occurred in 89.4% of cases. There was no significant difference between the forms of inner ear approach.
Decision Resources Group, Canada
Title: Innovations in diabetes care devices and their life changing implications
Manya Aggarwal is a Senior Analyst at Decision Resources Group. She has authored several reports on the Diabetes, Laparoscopic and Gynecological device markets in the Endoscopy division of the company. Prior to joining Decision Resources Group, Manya worked as an Economist at a healthcare startup based out of Toronto. Manya holds a Master Degree in Financial Economics and a Bachelor’s degree in Commerce and Economics from the University of Toronto.
According to the World Health Organization, over 6% of the world’s population lived with diabetes in 2014. This number is expected to increase to almost 8% by 2030. This makes the diabetes market one of the fastest-growing and most lucrative markets in the whole world. Medical device companies are therefore investing tremendous amounts of resources in new innovations that can make this chronic disease easier to manage. In my session, I would like to talk about the current market for diabetes devices (consisting of insulin pens, syringes, vials, self-monitoring blood glucose and continuous glucose monitoring devices) as well as address the following innovations and their impact on people living with diabetes: 1) Medtronic’s MiniMed 640Gdevice, which is currently still awaiting approval in the US, is a definite step in the direction of the creation of an “artificial pancreas”. I want to discuss how this novel device will make diabetes management more automated for type 1 diabetics. 2) Intarcia Therapeutics’ implantable pump device called the ITCA 650, is a thin implantable pump that holds the drug exenatide. Once commercially available, the pump would be implanted in abdominal tissue releasing the drug slowly over a period of approximately a year. I want to discuss how this would make diabetes management more automated for type 2 diabetics 3) CGM device innovations like the Senseonics CGM System and the GlySens ICGM which will both make continuous glucose monitoring much easier for type 1 diabetics
Manipal University, India
Title: Levonorgestrel Intra uterine system (LNG- IUS) for heavy menstrual bleeding to avoid hysterectomy
Pratap Kumar is the Head, Division of Reproductive medicine at Manipal University, National Vice President of the Federation of Obstetrics and Gynecology for the year 1999. Inspector, Examiner and Advisor, National Board of Examinations. Examiner of Undergraduates and Postgraduates in several universities Chairman of Board of Studies Clinical embryology at Manipal University Appointed on the Editorial committee of several Journals (Fertility & Sterility, Indian Section, Journal of Human Reproductive Sciences, Journal of Indian Obstetrics and Gynaecology, Journal of Perinatal and Neonatal Care, Journal of Fertility Science and Research, Journal of Women’s Health & Gynaecology). Has more than 250 publications and presented more than 500 presentations in National and International congresses
Introduction Heavy menstrual bleeding (HMB) is an important cause of ill health in women and it accounts for 12% of all gynecology referrals in the UK. Hysterectomy is often used to treat women with this complaint but medical therapy may be a successful alternative. The intrauterine Progesterone device was originally developed as a contraceptive but also resulted in a large reduction in menstrual blood loss. Hence, the use of the same in abnormal uterine bleeding was introduced. Material and Methods A total of 40 women were taken up for the study of Levonorgestrel Intra uterine system (MIRENA) with heavy menstrual bleeding after ruling out malignancy by uterine curettage. All the women had failure of medical treatment with oral progestogens. The duration of heavy menstrual bleeding was between 2 – 4 years. There were 15, 20 and 5 women with Dysfunctional uterine bleeding, Adenomyosis, and endometriosis respectively. Irrespective of the diagnosis control of bleeding was seen in 90% of cases. Menstrual blood loss was significantly reduced in 23 (57.5%) women and 15(37.5%) had complete amenorrhea. Of the 40 patients irregular spotting was seen in all women for duration of one to two months. Displacement was into cervical canal was seen in two women and both underwent hysterectomy as the bleeding continued heavily. Conclusions The LNG-IUS was the more effective first choice for management of menorrhagia compared with conventional medical treatment. More women were satisfied with the LNG-IUS and hysterectomy has been avoided in most of them.
Ion Beam Applications, Belgium
Title: High-Performance X-Ray systems for medical devices sterilization
Frédéric Stichelbaut has completed his PhD in High-Energy Physics at the Free University of Brussels (ULB) in Belgium in 1993. After his PhD, he worked 2 years at the European Organization for Nuclear Research (CERN) in Geneva and 4 years at Fermi National Laboratory in Chicago, Illinois for postdoctoral studies. He joined the Ion Beam Application (IBA) Company in 1999 and has been involved in R&D studies for the past 15 years. He has published more than 500 papers in peer-review journals and is a member of ASTM committee E61 on radiation processing. At IBA, he is in charge of all studies related to describe the interactions between particle beams and matter.
High-energy X-rays are produced by 5 to 7 MeV electron beams striking high-Z metallic targets made of Tantalum or Tungsten. The resulting X-rays have similar penetrating power as gamma rays produced by Cobalt-60 sources. Both X-rays and gamma irradiations are very effective for the sterilization of large loads of low-density products such as medical devices. The IBA Company has launched in the recent years the development of industrial irradiators allowing an efficient use of X-rays for the sterilization of medical devices on pallet. The proposed systems have been developed thanks to the use of state-of-the-art Monte Carlo simulation codes to optimize both their throughput and dose uniformity figures. This effort resulted in the installation of the first full X-ray facility in Danïken, Switzerland, operated by Synergy Health. Thanks to the unique TT1000 RhodotronTM accelerator developed by IBA, this facility uses a 7 MeV, 700 kW electron beam to generate X-rays used exclusively for medical devices sterilization. With 700 kW beam power, the Synergy Health facility can process up to 150,000 m³/year of low bulk density products. For a pallet load with density of 0.15 g/cm³, this X-ray system reaches a remarkable dose uniformity ratio better than 1.2.
Morriston Hospital, UK
Title: Dermatoscopy in plastic surgery
Ali Vahedi has completed his Medical Degree at the age of 23 years from Leicester Medical School, UK. He is currently a Surgical Trainee in the Welsh Deanery. He has been involved with numerous research projects and international presentations.
Introduction Dermatoscopy has become a useful non invasive technique, which has demonstrated evidence based improvement in diagnostic accuracy when used by dermatologists whilst assessing potential malignant skin lesions. Plastic surgeons are at the forefront of skin malignancy management; however the use of dermatoscopes by plastic surgeons remains questionable. The aim of this survey was to determine the awareness and use of dermatoscopes within the UK by plastic surgeons. Method The survey was conducted by contacting oncall Plastic Surgery Registrars within different hospitals in the UK. Data was recorded including, number of years experience in plastics, familiarity with dermatoscopes, whether the device was used by the individual, any formal training they had received, if the device was found to be useful and if the device was recommended. Results In total 17 different units were contacted. The mean number of years experience was 7.5 years. In total 16 (94%) were aware of adjuncts for diagnosing melanocytic lesions and 15 (88%) were familiar with dermatoscopes, although only 8 (47 %) had used the device. Furthermore only 1 (14%) person had received formal training. Overall 6 (75%) out of the 8 found it useful and would recommend the device for future use. Conclusion This survey demonstrates that the use of dermatoscopes within the plastic surgery community remains small. However a significant number, despite having no formal training, found the device to be of beneficial use. Reduce the number of unnecessary operations which will improve patient care and enable the department to become more economical.
ARKRAY Factory, USA
Title: Glucocard shine blood glucose monitoring system (BGMS) rates highly favorable in ease of use
John Gleisner completed his Ph.D. in Biochemistry from the University of Minnesota and postdoctoral studies from the University of Iowa. His first career following graduate school was at the Virginia Mason Research Center in Seattle, WA. He later moved into industry where he is currently the Science Director at ARKRAY Factory in Minneapolis, MN. Gleisner has spent nearly 30 years working on blood glucose system development and support. He has authored over 25 publications and holds 11 U.S. patents.
Background As a part of the 510(k) process for Blood Glucose Monitoring Systems (BGMS) in the monitoring of Diabetes Mellitus, Ease of Use criterion is evaluated with questionnaires following participation in the clinical trial. It is critical that a BGMS be easy to use since it is an important tool in the management of diabetes. Without the ability to regulate one’s blood glucose, an individual is at risk for potential micro and macrovascular complications. Purpose The objective of this study was to evaluate the Ease of Use for the GLUCOCARD Shine BGMS. Methods A total of 100 subjects evaluated the GLUCOCARD Shine BGMS by answering a questionnaire directed at the usability of the device. A total of 35 items were evaluated on the questionnaire including 28 questions directed to the device and 7 questions to the test strip. The subjects were asked to rate the items for the device and test strip as Very Easy, Easy, Ok, Difficult and Very Difficult. For evaluation purposes these items were grouped as Very Easy/Easy/OK being considered positive responses and Difficult/Very Difficult as negative. Results Test results were analyzed by computing the five-scale ratings for each participant (Total 3500 = 703 + 1722 + 1028 + 47 test participants x 35 items). A total of 20.1% of participants responded that the device and test strip were very easy to use, 49.2% easy, 29.4% ok and 1.3% difficult. No participant rated the device or test strip as very difficult to use. Conclusion The GLUCOCARD Shine BGMS scored an overall average rating of 98.7% participants considering the BGMS Ok to Very easy to use.
University of Auckland, New Zealand
Title: Auditory divided attention and auditory long term potentiation with cochlear implants: Objective clinical measures
Nathan completed his MSc at the age of 27 years from the University of Auckland, New Zealand and did his undergraduate studies in Physiology and Psychology (BSc double major). He has one pending publication (Seminars in Hearing) from a voluntary project during third year, and that team has plans for three more publications from the project (multiple topic study design). He also plans to further his education in cochlear implants and auditory brain plasticity, either via clincial studies or a research career. In his spare time, Nathan enjoys classic cars, photography and travel.
PURPOSE OF STUDY: Measures of auditory plasticity (long term potentiation; aLTP) over short time periods is investigated (n=12 binaural NH, n=16 monaural NH, n=8 Cochlear Implant [CI]) and whether 13Hz tetanic auditory stimulation can induce aLTP for CI therapy purposes. To investigate the Brief Test of Attention (BTA) as a valid cognition test for CI recipients and establish whether re-standardisation is required for CI populations. METHOD: CI recipients aged 17.49 to 86.26 years (µ=55.70, σ =23.07) were tested. Eight participants had post-linguistic hearing loss onset, whereas six were pre-linguistic (n=4, <2 years) or “peri-linguistic” (n=2, 2-4 years). All received Cochlear™ devices (n=12 Nucleus24; n=2 Nucleus22) post-linguistically; 3 childhood, ten post-40, and one at 21. Clincial EEG used to investigate aLTP [Clapp et al’s (2005) methodology]. Monaural-stimulated control participants (n=8) age- and sex- matched to CI participants (n = 8) , in addition to binaural-monoaural comparison (n = 12 Binaural, n=16 monaural). BTA was conducted for all hearing loss EEG participants as a pilot study, and for six additional CI recipients in an ongoing followup study. RESULTS: No group shows evidence of aLTP. N1 amplitude decreased post-intervention; however, baseline-shift for N1 amplitude is evident for all groups. N1 amplitude was significantly larger for CI than NH, but latency was non-significant. N1 amplitude correlates with speech recognition in noise, for the CI group. BTA scores correlates with length of time using a CI (r=0.708, p=0.049). The CI (n = 16) mean BTA score is 55%±22% (range 25%-95%). Six participants passed published age-standardized scores (percentiles and impairment categories). Of the remaining participants, two were “borderline impaired” (2nd - 9th percentile), and six were below 2nd percentile for their age (“impaired”). BTA scores do not correlate with speech-perception-in-noise scores (50% SRT for sentences) (n=10; r=-0.236; p=.582). Similarly, BTA score against time with CI showed non-significant correlation (n=12; r=0.140; p=.664). CONCLUSIONS: Clapp et al’s (2005) findings were not replicated, nor was aLTP observed with monaural. Passive exposure to tetanizing auditory stimuli did not induce aLTP for people who use CIs. Attending to the tetanizing stimulus, or longer therapy, may be required for aLTP induction. N1 baseline-shift suggests passive learning; which may compromise aLTP detection. Lack of correlation between BTA and speech perception supports a divergent validity hypothesis i.e. the BTA is testing attention, not speech perception. The BTA does not seem to require high speech perception ability, making it a promising test of cognition for CI populations. However further data and subsequent re-standardisation is needed before the BTA could be used as a clinical test or screening tool.
Lecturer in Department of Medical Biochemistry, Faculty of Medicine, Al-Azhar University, Egypt; City New Damietta
Liver biopsy is gold standard for fibrosis assessment in hepatitis C virus (HCV) infection but its limitations led to the identification of non-invasive biomarkers. This study assesses the reliability of five biomarkers in estimating the stage of liver fibrosis/cirrhosis in chronic HCV patients versus METAVIR scoring. Methods One hundred HCV monoinfected patients who underwent liver biopsy and blood sampling were included. Liver fibrosis was staged (F0–4) and required laboratory tests were performed. AAR, API, APRI, FIB-4 and Pohl score were calculated and their receiver operating curves (ROCs), sensitivities, specificities, predictive values and accuracies were evaluated. Results There were 27, 44, and 29 patients at F0–F1, F2–F3, and F4 groups. Significant statistical differences were found regarding AST, vireamia, platelet count, prothrombin time and all biomarkers. From ROCs only Pohl score predicted significant fibrosis and cirrhosis but with low accuracy. AAR, API and APRI showed moderate performance at low cut-offs, but had limited predictive values or accuracies at higher cut-offs. FIB-4 was the least accurate test. The diagnostic reliability of these biomarkers was limited to patients with suspected insignificant fibrosis. Conclusions This study verified the limited reliability for AAR, API, APRI, FIB-4 and Pohl score in estimating the stage of hepatic fibrosis in HCV infected patients opposed to METAVIR scoring.
Anwar Tawfik Amin
South Egypt Cancer Institute, Egypt
Title: Safety and feasibility of laparoscopic colo-rectal surgery for cancer at a tertiary center in a developing country: Egypt as an example
Anwar Tawfik Amin, Egyptian oncologist has done research in surgical stress on microscopic residual cancer after surgery. Monbokagakusho grant, Japan Government. Member of Egyptian Soi. Surgical Oncology. M D, Assiut University, faculty of medicine, 2001; Doctor of Philosophy, Japan, Oita University, Graduate school of medicine, 2010.
Background: Laparoscopic colectomy has been shown to have significant short- and long-term benefits compared to open approach. The incorporation of laparoscopy in developing countries is challenging, due to the high costs of equipment and lack of expertise. The aim of this study was to evaluate the safety and feasibility of laparoscopic colorectal surgery for cancer that could be performed in developing countries under different circumstances in developed countries. Methods: Thirty-seven patients (23 males and 14 females) with colorectal cancer with a median age of 46 years (39–72) have been enrolled for laparoscopic colo-rectal surgery in a tertiary center in Egypt (South Egypt Cancer Institute) with the trend of reuse of some disposable laparoscopic instruments. Results: The median operative time was 130 min (95–195 min). The median estimated blood loss was 70 ml (30–90 ml). No major intra-operative complications have been encountered. Two cases (5.5%) have been converted because of local advancement (one case) and bleeding with unavailability of vessel sealing device at that time (one case). The median time for passing flatus after surgery was 36 h (12–72 h). The median hospital stay was 4.8 days (4–7 days). The peri-operative period passed without events. Pathologic outcome revealed that the median number of retrieved lymph nodes was 14 (range 9–23 lymph node) and all cases had free surgical margin. Conclusion: Laparoscopic colorectal surgery for cancer in developing countries could be safe and feasible. Safe reuse of disposable expensive parts of some laparoscopic instruments could help in propagation of this technique in developing countries.
Title: Lateral flow immune-assays: limitations and perspectives
Gurdyal Singh has completed his PhD at the age of 31 years from Panjab University, Chandigarh with CSIR-Junior Research Fellowship & Senior Research Fellowship and working in invitro diagnostics. He is the Production Manager of Diagnocure (India), a premier manufacturer of invitro diagnostic kits. He has published more than 4 papers in reputed.
Lateral flow immune-assays (Rapid tests) are currently used for qualitative, semi quantitative and to some extent quantitative monitoring in resource-poor or non-laboratory environments. Applications include tests on pathogens, drugs, hormones and metabolites in biomedical, phytosanitary, veterinary, food and environmental factors. We describe principles of current formats, applications, limitations and perspectives for qualitative monitoring. We illustrate the potentials and limitations of analysis with lateral flow immune-assays using a literature survey and described its strengths, weaknesses, opportunities, threats.