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Low rates of Absorb BRS thrombosis beyond 12 months in patients treated with aggressive pre- and post-dilatation using highly non-compliant ...
Simultaneous intratunnel cross-linking with intrastromal corneal ring segment implantation versus simultaneous epithelium-off cross-linking with intrastromal corneal ring segment implantation for keratoconus management Mohamed Hosny, Moustafa Nour, Sarah Azzam, Mohsen Salem, Esraa El-Mayah Department of Ophthalmology, Cairo University, Giza, Egypt Purpose: The purpose of this study is to compare the efficacy of intratunnel cross-linking combined with intrastromal corneal ring segment (ICRS) implantation versus combined epithelium-off (epi-off) cross-linking and ICRS implantation for the management of keratoconus.Methods: Our study included 20 eyes of 12 patients with moderate-to-severe keratoconus. Group A included 10 eyes that underwent simultaneous ICRS implantation with intratunnel cross-linking. Group B included 10 eyes that underwent simultaneous ICRS implantation with epi-off cross-linking. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest sphere and
TY - JOUR. T1 - Short-term in vivo studies of surface thrombosis in a left ventricular assist system. AU - Yamanaka, Hanako. AU - Rosenberg, Gerson. AU - Weiss, William. AU - Snyder, Alan J.. AU - Zapanta, Conrad M.. AU - Siedlecki, Christopher. PY - 2006/5/1. Y1 - 2006/5/1. N2 - Thrombosis continues to be a major adverse and at times fatal event in patients with left ventricular assist systems (LVAS). To assess acute thrombosis in an LVAS, multiscale analysis of surface thrombosis was performed on LVAS blood sacs retrieved after implantation in seven calves for 3 days. Two study groups were evaluated: One group was given heparin and warfarin sodium throughout the study; the second received no postoperative anticoagulation. On explantation, the blood sacs were examined for macroscopic thrombi; microscale thrombosis was assessed with the use of scanning electron microscopy. Macroscopic thrombi about 1 mm in diameter were seen in all sacs from both groups. Although macroscopic thrombi occurred in ...
This invention is an intrastromal corneal ring having comprising at least one outer layer of a physiologically compatible polymer having a low modulus of elasticity, which polymer may be hydratable and may be hydrophilic. The inner portion of the hybrid intrastromal corneal ring may be hollow or may contain one or more physiologically compatible polymers.
Baxter received pre-market approval from the FDA for Novacor Left Ventricular Assist System, a pump implanted in the abdomen of heart transplant patients.
HeartWare is also giving Valtech warrants to purchases 850,000 Heartware shares at $83.73 if Valtech product sales eclipse $75 million annually, and if sales cross above $450 million annually, Valtech will receive another $375 million, either in stock or cash at Heartwares discretion.. Overall, the acquisition expands HeartWare into a highly complementary market given that HeartWares ventricular assist devices are often accompanied by a mitral or tricuspid valve procedure.. Now what: There are approximately 4.2 million and 1.6 million mitral and tricuspid valve disease patients in the U.S., respectively, and that could mean that the market opportunity associated with treating these conditions is worth billions of dollars.. Of course, tapping into that market opportunity depends a lot on HeartWare receiving regulatory go-ahead to begin marketing Valtechs next-generation products, including Cardioband. A decision is expected out of the EU on Cardioband later this year, and HeartWare anticipates ...
Following ventricular assist device (VAD) implantation, and observing conventional post-operative care, most patients should be able to be weaned from mechanical ventilation and woken within a few hours, providing that they remain hemodynamically stable and meet CMV weaning criteria. To ensure a patients hemodynamic stability during the early postoperative period, they must maintain a normal sinus rhythm, mean arterial blood pressure (MAP) of 60-80mmHg, central venous (CVP) and pulmonary artery wedge (PAWP) pressures less than 15mmHg and a cardiac index above 2.51min-1m-2. Although CMV weaning criteria can differ depending on the institution, recommended criteria includes pH ,7.25, partial pressure of oxygen in the arterial blood (PaO2) ,60mmHg, fraction of inspired oxygen (FIO2) ,0.4, PaO2/FIO2 (P/F) ratio ,150mmHg, positive end expiratory pressure (PEEP) , 8cmH2O, and the patients capability of triggering the ventilator [14].. Ventilator settings. A common complication faced after LVAD ...
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy). Subjects will be randomized to HeartWare® HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare® HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 5 years post implant ...
In the present retrospective study, we have demonstrated that stroke after LVAD implantation has a right hemispheric predominance and right hemispheric stroke after LVAD implantation was more often associated with infection compared with left hemispheric stroke. The incidence of stroke after LVAD placement was reported previously to be 8.0% to 25.0%.2,4 The overall incidence of stroke in our cohort was 12.9%.. Regarding the hemispheric distribution of stroke, the results of our observation are consistent with previous reports describing the mechanism of right-hemispheric dominance of cardiogenic embolisms after cardiac surgery.5-8 Considering any thrombus inside the LVAD pump as a part of cardiac embolic material in addition to actual intracardiac thrombi, right-to-left propensity of stroke after LVAD can be easily explained by anatomic alignment of the arteries arising from aortic arch. Moreover, surgical manipulation of LVAD outflow cannula-to-ascending aorta anastomosis may also direct ...
Retention rates at 18, 24, and 36 months respectively were 92%, 87%, and 75%. The risk of failure by any criterion was similar for the Ahmed and Baerveldt implants (risk ratio = 1.0, p=0.88, 95% CI=0.7, 1.6); however, the risk of reoperation for glaucoma was 2.0 times higher with the Ahmed implant than the Baerveldt implant (p=0.074, 95% CI=0.9, 4.4). At 36 months, mean (SD) IOP was 14.3 mmHg (4.9) in the Ahmed group and 12.9 mmHg (4.4) in the Baerveldt group (p=0.049). The mean (SD) number of IOP lowering medicines was 1.9 (1.4) in the Ahmed group and 1.5 (1.4) in the Baerveldt group (p=0.048).. ...
...FRAMINGHAM Mass. and SYDNEY March 7 2011 /- HeartWare ...A live webcast of the Companys presentation at the conference will be... About HeartWare InternationalHeartWare International develops and m... HeartWare International Inc. is a member of the Russell 2000®...,HeartWare,to,Present,at,the,Barclays,Capital,2011,Global,Healthcare,Conference,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
Wishing to get some outside input on a pacemaker situation. I am trying to find out if the right ventricular lead can be removed from the apex and relocated at the right ventricular outlet tract (...
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details ...
HeartWare Internationals recall of their Ventricular Assist System, also known as the HeartWare Ventricular Assist Device (HVAD) has been classified as Class I by the U.S. Food and Drug Administration (FDA). The Class I designation is the agencys most serious warning; it means that there is a reasonable risk of serious injury or death associated with exposure to the device. The system was recalled in December due to a failed locking mechanism. Last week, the company issued a reminder about the defect, citing 8 reports where the locking mechanism failed to engage.. HeartWare issued a news release last Thursday reminding patients and healthcare professionals about the driveline connector defect in its HVAD. The release mentioned 8 reports where the locking mechanism failed in the circulatory support system. In four of these cases, the failed locking mechanism caused the pump to temporarily stop. This "could cause serious injury or death, depending on the function of a patients native heart" the ...
Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, helps the heart pump and increases the amount of blood that flows through the body.
Independent and incremental role of quantitative right ventricular evaluation for the prediction of right ventricular failure after left ventricular assist device implantation
Retinal prosthesis devices have shown great value in restoring some sight for individuals with profoundly impaired vision, but the visual acuity and visual field provided by prostheses greatly limit recipients visual experience. In this paper, we employ computer vision approaches to seek to expand the perceptible visual field in patients implanted potentially with a high-density retinal prosthesis while maintaining visual acuity as much as possible. Approach. We propose an optimized content-aware image retargeting method, by introducing salient object detection based on color and intensity-difference contrast, aiming to remap important information of a scene into a small visual field and preserve their original scale as much as possible ...
The SCID mouse model for rheumatoid arthritis (RA) is an established and reliable approach to examining the distinct mechanisms operative in RA synovium, and evaluating novel gene therapy strategies. However, serum concentrations of circulating gene therapy products following gene transfer are frequently too low to allow detection. This problem stimulated us to develop a novel implantation technique to improve the yield of these soluble gene products. Synovial fibroblasts from patients with RA were cultured, passaged, and transduced with Ad5 sTNFRp55:Ig. sTNFRp55:Ig production was confirmed by ELISA, and then cells were implanted into SCID mice using a novel implantation strategy in which pieces of human cartilage were engrafted into a fibroblast-saturated inert sponge. Thereafter, the sponges were implanted under the skin of the mice instead of under the kidney capsule, as in the original approach, allowing co-implantation of larger pieces of cartilage together with higher numbers of ...
Developing a retinal prosthesis requires getting several complex systems to work smoothly together. Not the least of the challenges lies with integrating the devices electrical components. The BMES researchers designed and built a test system that consisted of: an external camera and laptop to process video data; a wireless transmitter and receiver coil to send and capture data, respectively; a processor to translate data into stimulative electrical current among 256 different channels; and a 16-by-16 LED array for displaying the stimulas current as visual output.. In addition, the test demonstrated a powerful imaging technique that will be used to design the complex mathematical models needed to improve future retinal impants.. ...
How should I prepare for an ICD implantation? Before the procedure, be sure to talk to you doctor about which of your medications you should and should not take. If you are taking any medications for diabetes, ask your doctor if you need to adjus
The HVAD® Pump is great! I cant say enough about it. The equipment is VERY EASY TO LEARN. Now I dont even think about it - its part of what I do every day. Its a part of me ...
In Chapter 1, "The Old Man of La Chapelle: The Patriarch of Paleo," author Lydia Pyne explains the publics evolving conception of the first complete Neanderthal skeleton found and described by scientists.. 1 Comment. ...
Harvesting lab-raised zebrafish based on their size led to differences in the activity of more than 4,000 genes, as well as changes in allele frequencies of those genes, in the fish that remained.. 0 Comments. ...
Medtronic has announced that the Food and Drug Administration has classified global voluntary recalls of HeartWare Internationals HVAD as Class 1 recalls.
Background: In this study, we aimed to investigate frequency, patterns, etiologies, and costs of unplanned readmissions after left ventricular assist device implantation.. Methods: Between April 2012 and September 2016, 99 unplanned readmissions of a total of 50 consecutive bridge-to-transplant patients (45 males, 5 females; mean age 46.9±10.3 years; range, 19 to 67 years) who were successfully discharged after left ventricular assist device implantation were retrospectively analyzed. Patient demographic data, hemodynamic measurements before implantation, and readmissions after discharge were recorded. Hospitalizations due to major problems which were unable to be managed in routine outpatient clinic were accepted as unplanned readmissions. Survival analysis was performed.. Results: The readmission rate was 1.7 per year after discharge. Survival of patients who were readmitted within the first 90 days was found to be significantly lower than those without early readmission. The most common ...
Definition of capsular tension ring in the Legal Dictionary - by Free online English dictionary and encyclopedia. What is capsular tension ring? Meaning of capsular tension ring as a legal term. What does capsular tension ring mean in law?
Forty-two eyes of 26 patients, 14 men and 12 women, with postoperative keratectasia after PRK (8 eyes, Group A) and LASIK (34 eyes, Group B) were included in a nonrandomized, retrospective, observational case series. Mean age at the time of ICRS implantation was 30.5 years. Mean follow-up was 23,5 months (range, 1 to 86 months). Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.. ...
Both Kerarings and Intacs have been shown to be an effective method of improving vision when used in isolation for patients with keratoconus. In 2014 Torquetti et al. [17] published data showing that Kerarings could effectively improve UDVA and CDVA in patients with keratoconus. Fahd et al. [18] showed Intacs to be safe and effective when used to treat eyes with moderate to severe keratoconus. However, recent data has suggested that there is regression in visual, refractive and topographic measures 5 years after ISCRS implantation [19]. This regression is to be expected as although the ISCRS flatten the cornea, they do not prevent the progression of the disease itself. CXL has therefore been used in combination with ISCRS to address this and provide the maximal visual improvement for the patient [20-22]. Our data shows ISCRS (INTACS and Kerarings) combined with CXL treatment to be a safe and effective treatment for keratoconus. We found both INTACS and Kerarings combined with CXL to produce a ...
Abbott Introduces HeartMate 3 Left Ventricular Assist System - the Latest Milestone In Therapy For Advanced Heart Failure Patients - Abbott pioneered the evolution of heart pumps; U.S. approval of the H
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Disclaimer The HeartWare(r) Ventricular Assist System is the subject of an investigational clinical trial in the United States for a bridge-to-transplant indication. Pursuant to United States federal law, the HeartWare(r) Ventricular Assist System is restricted solely to investigational use in the United States. The HeartWare(r) Ventricular Assist System has received CE Marking and is thereby approved for sale in the European Union for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory, end-stage heart failure. The following physician presentation represents one implanting centers clinical experience with the HeartWare(r) Ventricular Assist System to-date. Results may vary between clinical sites and may not be necessarily reflective of results at other clinical sites or in other countries. The comments, views and data expressed in the ensuing presentation may not reflect HeartWares position as it applies to, among other things, the uses for which ...
Methods and Results Using a large US commercial insurance database, patients who received an LVAD (International Classification of Diseases, 9th Revision, Clinical Modification code 37.66) and survived to hospital discharge without heart transplantation between January 1, 2006, and March 31, 2015, were identified. Heart failure medication use from 3 months before 1‐year post‐LVAD was examined using linked pharmacy claims. Differences in the proportion of patients taking heart failure medications post LVAD compared with pre LVAD were examined using McNemar test. Predictors of post‐LVAD medication use and poor medication adherence (proportion of days covered ,0.8) were identified via logistic regression. Among 362 patients (mean age, 57.4 years; 75.1% men), compared with pre LVAD, the proportion of patients taking anticoagulants and antiarrhythmics following LVAD increased; mineralocorticoid receptor antagonists, thiazide diuretics, and digoxin decreased; and β‐blockers, ...
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In our cross-sectional cohort, iron deficiency was the most common cause of anemia. Notably, 49% of the iron-deficient patients were already on iron supplementation. In our retrospective cohort, 59% of the patients were anemic after 6 months of support. Anemic patients were older, had lower albumin, higher brain natriuretic peptide (BNP), worse renal function and New York Heart Association (NYHA) class. Anemia had a HR of 3.16 (95%CI 1.38-7.26) to predict a composite of 1-year death and HF readmissions, as well as HF-readmissions alone.. ...
The StabilEyes® Capsular Tension Ring provides exceptional intraoperative stability for cataract patients with zonular weakness.
PUNDI, BHARATRAM SATYANARAYANAN. Class-E Power Amplifier Design and Back-Telemetry Communication for Retinal Prosthesis. (Under the direction of Wentai Liu.) This thesis discusses the power link in the retinal prosthesis project that aims to provide vision to the profoundly blind. Clinical experiments have confirmed that electrical stimulation can be used to duplicate the action of photoreceptors in the retina to provide vision to blind patients suffering from RP/AMD. The retinal prosthesis system consists of an intraocular unit implanted inside the eye and a separate extraocular unit. The microstimulator involved in retinal prosthesis consists of multiple electrodes arranged in twodimensional array and is a part of the intraocular unit. The micro-stimulator needs data and power to be transferred wirelessly from the extraocular unit. The power link consists of a highly efficient Class-E driver that transfers power inductively to the intraocular unit. A Class-E power driver is developed to suit ...
TY - JOUR. T1 - Survival After Orthotopic Heart Transplantation in Patients Undergoing Bridge to Transplantation With the HeartWare HVAD Versus the Heartmate II. AU - Magruder, J. Trent. AU - Grimm, Joshua C.. AU - Crawford, Todd C.. AU - Tedford, Ryan J.. AU - Russell, Stuart D.. AU - Sciortino, Christopher M.. AU - Whitman, Glenn. AU - Shah, Ashish S.. PY - 2016. Y1 - 2016. N2 - Background: Our objective was to determine whether the choice of a HeartWare HVAD as opposed to a Heartmate II left ventricular assist device (HMII LVAD), impacts survival after heart transplantation after controlling for patient, donor, and center characteristics. Methods: We queried the United Network for Organ Sharing (UNOS) database, which has recently made pretransplantation device duration available, for all adult patients undergoing bridge to transplantation (BTT) between January 2011 and March 2016. Recipient, donor, and transplant-specific characteristics were compared between patients receiving either device. ...
...Joins Two Noted Cardiothoracic Surgeons to Lead Pivotal Trial ... ...ANN ARBOR Mich. March 17 /- Terumo Heart Inc. today ann... ...,David,Feldman,,M.D.,Appointed,Co-Principal,Investigator,of,DuraHeart(TM),Left,Ventricular,Assist,System,U.S.,Clinical,Trial,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
Introduction: Stenosis in the continuous-flow left ventricular assist device (CF-LVAD) outflow graft can be caused by various mechanical and anatomical factors. Increasingly, percutaneous management has been utilized to re-establish adequate CF-LVAD flow. We sought to evaluate indications for such interventions and their outcomes. Methods: An electronic search was performed to identify all studies in the English literature reporting CF-LVAD outflow graft stenting for various etiologies. Twenty-one studies consisting of 26 patients were included in the analysis. Results: Median patient age was 59 years [45.8-67.0] and 65.4% (17/26) were male. 58.3% (14/24) of patients had HeartWare HVAD, 37.5% (9/24) had HeartMate II LVAD, and 4.2% (1/24) had HeartMate III LVAS. Median time from device placement to outflow graft stenting was 24.0 months [7.8-30.4]. 76.9% of patients (20/26) presented with heart failure. 34.6% (9/26) had outflow graft thrombosis, 34.6% (9/26) stenosis, 11.5% (3/26) kinking, 11.5% (3/26)
Background: Acute heart failure (AHF) is the first cause of hospitalization for over-65 individuals, associated with high mortality and readmission rate. The aim of this study was to assess the prognostic value of a multiparametric score combining clinical, biochemical and echocardiographic indexes in AHF for clinical practice.. Methods: 830 patients hospitalized for AHF were enrolled. Exclusion criteria were: active neoplasms; previous heart transplantation or left ventricular assist device implantation. Different variables were analyzed: etiology of AHF, clinical and biochemical data, lung congestion on chest-X ray, echocardiographic parameters and administered therapy. The endpoints were: all-cause mortality at 30 days, 6 months and 5 years and the duration of hospitalization.. Results: 771 patients met eligibility criteria. Using the univariate and multivariate analysis the indexes with the best correlation with outcome were discretized and used to create the ACUTE HF score, computed as: ...
Driveline or device infection may complicate left ventricular assist device implants, and only curative option may be pump exchange. Replacement with similar device may be liable to reinfection, because pump configuration is such that the new device and driveline may partly lie within the pocket of the previous pump. One approach to overcome this is using a different pump design such that the new pump would lie in a different location from the old pump. We describe treatment of severe HeartMate II (Abbott, [St Jude Thoratec Corp], Pleasanton, CA USA) left ventricular assist device infection by minimally invasive exchange to an intrapericardial HVAD (HeartWare International, Inc, Framingham, MA USA) left ventricular assist device ...
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NEW YORK, July 26, 2016 /PRNewswire/ -- Healthcare Sector Equities Under Review -- Intrexon, Alkermes, BioScrip, and Heartware Intl.
FRAMINGHAM, Mass., Feb. 3, 2016 /PRNewswire/ -- HeartWare Presentation At The Leerink Partners 5th Annual Global Healthcare Conference To Be Webcast.
Out of the five senses that you have, which is the one that you would deem to be most important? It would be an extremely difficult question for me to answer, as I treasure my sight, smell, touch, taste and hearing equally - and lacking in one is more than enough to make life difficult. Having said that, I salute the indomitable human spirit and those who have achieved so much more than normal able-bodied folks even when missing one (or more) of the five senses. Having said that, there is some hope for the blind thanks to the efforts of Second Sight who came up with the Argus II Retinal Prosthesis. This rather unique piece of technology will basically allow a blind user to "see" objects, as well as colors and movement within their environment. Just how is this achieved? Normally, it is done thanks to the assistance of a video-camera-equipped pair of glasses that is worn by the user. However, a recent experiment saw researchers do away with the camera, and they instead transmitted visual Braille ...
If you or a loved one suffered complications or death due to a defective ventricular assist device (VAD), contact Thomas J. Henry for a free case review.
May 12, 2012 by JMP · Leave a Comment The KPro Study Group was established in 1990 at the Bascom Palmer Eye Institute by Parel, Alfonso, Lacombe and Legeais to foster clinical and basic research on keratoprosthesis, synthetic corneas and artificial corneal implants. This International Group aims to foster the development and improvement of keratoprosthesis worldwide for the benefit of eyecare and our patients. The Group is comprised of researchers and surgeons involved in this specialized field, and regular conferences are held to facilitate communication and research development.. 2012 KPro Steering Committee. Honorary President:. Michael Roper-Hall, UK (1991). Honorary Members: ...