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Lohmann C.H.,Otto Von Guericke University of Magdeburg | Meyer H.,Otto Von Guericke University of Magdeburg | Nuechtern J.V.,University of Hamburg | Singh G.,National University of Singapore | And 4 more authors.
Journal of Bone and Joint Surgery - Series A | Year: 2013

Background: Tissue responses to periprosthetic metal wear debris are complex and poorly understood. There are two predominant tissue responses: a nonspecific macrophage-mediated granulomatous response and lymphocyte-dominated response, which has immunological memory and is mediated by T cells. Delayed hypersensitivitytype responses may accelerate aseptic loosening of arthroplasty implants. We hypothesized that the metal content of periprosthetic tissue but not of serum would be predictive of the type of tissue response to metal wear debris. Methods: We examined twenty-eight total hip arthroplasty implant retrievals from twenty-seven patients who had undergone revision arthroplasty at one institution. Indications for revision were pain and/or osteolysis; one patient had recurrent dislocations. Tissue samples were analyzed microscopically and the metal (Co, Cr, and Ni) content was determined. Explanted prosthetic components were examined for linear wear. Intraoperatively, periprosthetic metallosis was observed in twelve cases and formation of a bursa (pseudotumor) was observed in thirteen. The acetabular cup was loose in eleven cases, the femoral stem was loose in five, and both components were loose in five. Results: The metal (Co, Cr, and Ni) content of the periprosthetic tissue ranged from 1.4 to 4604.0 mg/g. Histologically, macrophages containing metal particles as well as diffuse and perivascular lymphocytic infiltration were observed. Fibrin exudation was also visible. Tissues that displayed a predominantly lymphocytic response had a mean metal content of 222.2 ± 52.9 mg/g, whereas those that displayed a macrophage-dominated response had a metal content of 3.0 ± 0.9 mg/g; this difference was significant (p = 0.001). The mean serum metal content did not differ significantly between the two subgroups (60.7 ± 13.4 compared with 43.7 ± 3.8 mg/L, p = 0.105). Conclusions: An association between periprosthetic tissue metal content and hypersensitivity appears likely but needs to be validated with larger-scale retrieval studies. Clinical Relevance: This study contributes to the understanding of tissue responses to metal wear debris after joint replacement and the factors that are predictive of a type-IV lymphocyte-dominated hypersensitivity reaction. Copyright © 2013 By The Journal of Bone and Joint Surgery, Incorporated.


OMER, Israel, Dec. 13, 2016 (GLOBE NEWSWIRE) -- Medigus Ltd. (Nasdaq:MDGS) (TASE:MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, today announced the completion of a live transoral fundoplication (TF) procedure using the Medigus Ultrasonic Surgical Endostapler (MUSE™) system. The procedure was performed at the Endo-Update, one of the largest and most well-attended live endoscopy conferences in Europe, by renowned gastroenterologists from Germany, Professors Helmut Messmann, Klinikdirektor and Internist, Gastroenterologe at Klinikum Augsberg and Horst Neuhaus, MD, Head of the Department of Gastroenterology of the Evangelisches Krankenhaus in Düsseldorf, Germany. The procedure was performed on a 34 year old male patient, who had been presenting with symptoms of GERD for five years, with no prior surgery for this condition. “MUSE addresses an unmet need in long-term GERD care by providing a true solution between drug therapy and invasive surgical procedures,” said professor Messmann. “By addressing the anatomical cause of GERD, patients can find long-term relief from troublesome symptoms following a patient-friendly procedure, and be able to return to their daily activities within a couple of weeks.” The MUSE system integrates the latest innovations in microvisualization, ultrasound and surgical stapling capabilities into one platform, enabling a single physician to perform transoral fundoplication for the treatment of GERD. MUSE has the potential to improve GERD-related quality of life for many patients by addressing the root cause of the disease, not just offer symptom relief, which is often in contrast to many drug therapies. “I am pleased to demonstrate to the European gastroenterology and endoscopy communities the clinical and patient benefits of MUSE over more invasive techniques,” said professor Neuhaus. “This procedure is generally well-tolerated by most patients and the technique can be repeated if needed, which may be beneficial for patients with severe GERD.” GERD is a common and costly disorder in Germany1, one that can increase with a person’s age. In a study of over 7,000 patients, 14% of subjects suffered moderate symptoms and 4% suffered severe symptoms.2 Because of their high prevalence, reflux symptoms are of major public health importance.2 In Germany, the impact of GERD on the ability to work as well as on overall work-related productivity has been studied and found that 61% of patients experienced reduced productivity as a consequence of their disease.3 “GERD can have widespread impact on a patient’s health-related quality of life. Medigus’ MUSE system has the potential to offer a meaningful solution to thousands of people who suffer with this disease in Germany and around the world,” said Chris Rowland, CEO of Medigus. “We are honored to work with leaders such as professors Messman and Neuhaus, and we thank them for their support raising awareness of this important technology amongst their peers.” About GERD Gastroesophageal reflux disease (GERD) occurs when the lower esophageal sphincter spontaneously opens or does not properly close after use, allowing stomach acids to rise (or reflux) into the esophagus, which causes heartburn, irritation and potentially other discomforts. GERD affects approximately 81 million Americans each year, 8.6 million of whom experience severe symptoms.i While some patients can attain symptom relief through the use of proton pump inhibitors, or PPIs, (acid reducing medications), there is growing concern around the prolonged use of PPIs, including increased risk of renal failureii, dementiaiii, bone fracture and interference with the adsorption of essential vitamins and minerals.iv A persistent state of untreated GERD may lead to Barrett’s esophagus, a precancerous condition which can progress to esophageal cancer. Patients who suffer from persistent GERD are seven times more likely to develop esophageal cancer.ii About The MUSE™ System The MUSE™ system is a flexible transoral stapler that enables a minimally-invasive procedure for the long-term treatment of GERD. The device is fully integrated with latest technological advancements in microvisualization, ultrasound and surgical stapling, which allows a single physician or surgeon to perform anterior partial fundoplication more easily than with leading laparoscopic methods. Its intuitive endosurgical platform consists of a single use flexible surgical endostapler, equipped with a proprietary miniature camera, an ultrasonic sight and a range finder, and includes a handle with controls, an 80 cm flexible shaft, a 5 cm rigid section holding a cartridge with 5 standard 4.8mm titanium surgical staples, a ratchet controlled one-way articulating section, and a new, rounded distal tip for easier insertion. The MUSE system is FDA cleared and CE marked for the treatment of GERD and is reimbursable in the U.S. under Current Procedural Terminology (CPT®) code 43210 for Esophagogastric Fundoplasty Trans-Orifice Approach. CPT codes are descriptive terms physicians use for reporting all medical, surgical, and diagnostic services and procedures; Category I codes are most frequently used by healthcare providers when reporting a significant portion of their services. MUSE also has obtained the necessary licenses to market the product in Canada and Israel. For more information, visit www.RefluxHelp.com. This press release may contain statements that are “Forward-Looking Statements,” which are based upon the current estimates, assumptions and expectations of the company’s management and its knowledge of the relevant market. The company has tried, where possible, to identify such information and statements by using words such as “anticipate,” “believe,” “envision,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate” and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words.  These forward-looking statements represent Medigus’ expectations or beliefs concerning future events, and it is possible that the results described in this news release will not be achieved. By their nature, Forward-Looking Statements involve known and unknown risks, uncertainties and other factors which may cause future results of the company’s activity to differ significantly from the content and implications of such statements. Among the factors which may cause the actual results to differ from the Forward-Looking Statements are changes in the target market and the introduction of competitive products, our ability to secure favorable reimbursement rates, regulatory, legislative and policy changes, and clinical results. Other risk factors affecting the company are discussed in detail in the Company's filings with the Securities and Exchange Commission. Forward-Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no obligation to update or revise any Forward-Looking Statements, whether as a result of new information, future developments or otherwise. Neither the company nor its shareholders, officers and employees, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities. Nothing in this press release should be deemed to be medical or other advice of any kind. 1 Gross M, Beckenbauer U, Burkowitz J, Walther H, Brueggenjuergen B. Impact of gastro-esophageal reflux disease on work productivity despite therapy with proton pump inhibitors in Germany. Eur J Med Res. 2010;15:124-130. 2 Nocon M, Keil T, Willich SN. Prevalence and sociodemographics of reflux symptoms in Germany - results from a national survey. Aliment Pharmacol Ther. 2006;23:1601-1605 3 Gross M, Beckenbauer U, Burkowitz J, Walther H, Brueggenjuergen B. Impact of gastro-oesophageal reflux disease on work productivity despite therapy with proton pump inhibitors in Germany. Eur J Med Res. 2010;15:124-130. i Rubenstein JH & Taylor JB. (2010). Meta-analysis: the association of oesophageal adenocarcinoma with symptoms of gastro-oesophageal reflux. Alimentary Pharmacology & Therapeutics,32(10):1222-7. doi: 10.1111/j.1365-2036.2010.04471.x. Epub 2010 Sep 23. ii Lazarus, B., Chen, Y., Wilson, F. P., Sang, Y., Chang, A. R., Coresh, J., & Grams, M. E. (2016). Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease.JAMA Internal Medicine JAMA Intern Med, 176(2). doi:10.1001/jamainternmed.2015.7193 iii Gomm, W., Holt, K. V., Thomé, F., Broich, K., Maier, W., Fink, A., . . . Haenisch, B. (2016). Association of Proton Pump Inhibitors With Risk of Dementia. JAMA Neurology JAMA Neurol, 73(4), 410. doi:10.1001/jamaneurol.2015.4791 iv Tetsuhide Ito, MD, PhD & Robert T. Jensen, MD (2010). Association of Long-term Proton Pump Inhibitor Therapy with Bone Fractures and effects on Absorption of Calcium, Vitamin B12, Iron, and Magnesium. Current Gastroenterology Reports, 12(6): 448–457. doi:  10.1007/s11894-010-0141-0


Ledermann J.,University College London | Harter P.,Kliniken Essen Mitte | Gourley C.,University of Edinburgh | Friedlander M.,Prince of Wales Hospital | And 11 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: Olaparib (AZD2281) is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitor that has shown antitumor activity in patients with high-grade serous ovarian cancer with or without BRCA1 or BRCA2 germline mutations. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 2 study to evaluate maintenance treatment with olaparib in patients with platinum-sensitive, relapsed, high-grade serous ovarian cancer who had received two or more platinumbased regimens and had had a partial or complete response to their most recent platinum-based regimen. Patients were randomly assigned to receive olaparib, at a dose of 400 mg twice daily, or placebo. The primary end point was progression-free survival according to the Response Evaluation Criteria in Solid Tumors guidelines. RESULTS: Of 265 patients who underwent randomization, 136 were assigned to the olaparib group and 129 to the placebo group. Progression-free survival was significantly longer with olaparib than with placebo (median, 8.4 months vs. 4.8 months from randomization on completion of chemotherapy; hazard ratio for progression or death, 0.35; 95% confidence interval [CI], 0.25 to 0.49; P<0.001). Subgroup analyses of progression-free survival showed that, regardless of subgroup, patients in the olaparib group had a lower risk of progression. Adverse events more commonly reported in the olaparib group than in the placebo group (by more than 10% of patients) were nausea (68% vs. 35%), fatigue (49% vs. 38%), vomiting (32% vs. 14%), and anemia (17% vs. 5%); the majority of adverse events were grade 1 or 2. An interim analysis of overall survival (38% maturity, meaning that 38% of the patients had died) showed no significant difference between groups (hazard ratio with olaparib, 0.94; 95% CI, 0.63 to 1.39; P = 0.75). CONCLUSIONS: Olaparib as maintenance treatment significantly improved progression-free survival among patients with platinum-sensitive, relapsed, high-grade serous ovarian cancer. Interim analysis showed no overall survival benefit. The toxicity profile of olaparib in this population was consistent with that in previous studies. (Funded by Astra- Zeneca; ClinicalTrials.gov number, NCT00753545.). Copyright © 2012 Massachusetts Medical Society.


Ledermann J.,University College London | Harter P.,Kliniken Essen Mitte | Gourley C.,University of Edinburgh | Friedlander M.,University of New South Wales | And 14 more authors.
The Lancet Oncology | Year: 2014

Background: Maintenance monotherapy with the PARP inhibitor olaparib significantly prolonged progression-free survival (PFS) versus placebo in patients with platinum-sensitive recurrent serous ovarian cancer. We aimed to explore the hypothesis that olaparib is most likely to benefit patients with a BRCA mutation. Methods: We present data from the second interim analysis of overall survival and a retrospective, preplanned analysis of data by BRCA mutation status from our randomised, double-blind, phase 2 study that assessed maintenance treatment with olaparib 400 mg twice daily (capsules) versus placebo in patients with platinum-sensitive recurrent serous ovarian cancer who had received two or more platinum-based regimens and who had a partial or complete response to their most recent platinum-based regimen. Randomisation was by an interactive voice response system, stratified by time to progression on penultimate platinum-based regimen, response to the most recent platinum-based regimen before randomisation, and ethnic descent. The primary endpoint was PFS, analysed for the overall population and by BRCA status. This study is registered with ClinicalTrials.gov, number NCT00753545. Findings: Between Aug 28, 2008, and Feb 9, 2010, 136 patients were assigned to olaparib and 129 to placebo. BRCA status was known for 131 (96%) patients in the olaparib group versus 123 (95%) in the placebo group, of whom 74 (56%) versus 62 (50%) had a deleterious or suspected deleterious germline or tumour BRCA mutation. Of patients with a BRCA mutation, median PFS was significantly longer in the olaparib group than in the placebo group (11·2 months [95% CI 8·3-not calculable] vs 4·3 months [3·0-5·4]; HR 0·18 [0·10-0·31]; p<0·0001); similar findings were noted for patients with wild-type BRCA, although the difference between groups was lower (7·4 months [5·5-10·3] vs 5·5 months [3·7-5·6]; HR 0·54 [0·34-0·85]; p=0·0075). At the second interim analysis of overall survival (58% maturity), overall survival did not significantly differ between the groups (HR 0·88 [95% CI 0·64-1·21]; p=0·44); similar findings were noted for patients with mutated BRCA (HR 0·73 [0·45-1·17]; p=0·19) and wild-type BRCA (HR 0·99 [0·63-1·55]; p=0·96). The most common grade 3 or worse adverse events in the olaparib group were fatigue (in ten [7%] patients in the olaparib group vs four [3%] in the placebo group) and anaemia (seven [5%] vs one [<1%]). Serious adverse events were reported in 25 (18%) patients who received olaparib and 11 (9%) who received placebo. Tolerability was similar in patients with mutated BRCA and the overall population. Interpretation: These results support the hypothesis that patients with platinum-sensitive recurrent serous ovarian cancer with a BRCA mutation have the greatest likelihood of benefiting from olaparib treatment. © 2014 Elsevier Ltd.


Peichl P.,Evangelisches Krankenhaus | Holzer L.A.,Evangelisches Krankenhaus | Maier R.,Thermenklinikum Baden | Holzer G.,Medical University of Vienna
Journal of Bone and Joint Surgery - Series A | Year: 2011

Background: Parathyroid hormone (PTH) has been shown to increase bone mineral density and to reduce the rate of fractures in patients with osteoporosis and also to improve fracture-healing. The purpose of the present prospective, randomized, controlled study was to evaluate the effect of PTH 1-84 on the course of pelvic fracture-healing and functional outcome in postmenopausal women. Methods: Sixty-five patients had a dual x-ray absorptiometry scan, radiographs, and a computed tomography scan to document pelvic fractures. Twenty-one patients received a once-daily injection of 100 mg of PTH 1-84 starting within two days after admission to the hospital, and forty-four patients served as the control group. All patients received 1000 mg of calcium and 800 IU of vitamin D. Computed tomography scans were repeated every fourth week until radiographic evidence of cortical bridging at the fracture site was confirmed. Functional outcome was assessed with use of a visual analog scale for pain and a Timed "Up and Go" test. Results: The mean time to fracture healing was 7.8 weeks for the treatment group, compared with 12.6 weeks for the control group (p < 0.001). At eight weeks, all fractures in the treatment group were healed and four fractures in the control group were healed (healing rate, 100% compared with 9.1%; p < 0.001). Both the visual analog scale score for pain and the result of the Timed "Up and Go" test improved in the study group as compared with the control group (p < 0.001). Conclusions: In elderly patients with osteoporosis, PTH 1-84 accelerates fracture-healing in pelvic fractures and improves functional outcome. Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence. Copyright © 2011 by The Journal of Bone and Joint Surgery, Incorporated.


Berges R.,PAN Klinik am Neumarkt | Hofner K.,Evangelisches Krankenhaus | Gedamke M.,Ferring Arzneimittel GmbH | Oelke M.,Hannover Medical School
World Journal of Urology | Year: 2014

Purpose: To evaluate the efficacy of desmopressin on nocturia, quality of sleep (QoS), and health-related quality of life (HRQoL) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) and nocturia due to nocturnal polyuria (NP) as the predominant symptom.Results: In total, 137 patients with a mean of 3.8 nocturnal voids (range 2–7) were included. Desmopressin significantly reduced the mean number of nocturnal voids by 53 %, mean IPSS nocturia question by 50 %, and the mean ratio of night/24-h urine volume by 39 % from baseline to endpoint. The hours of undisturbed sleep significantly increased by 74 %; 71 % of men reported about undisturbed sleep of ≥4 h at study end. Additionally, there was a significant reduction in the Leeds Sleep Evaluation Questionnaire score, indicating a clinically relevant QoS improvement. This was associated with an improved HRQoL, as shown by a significant improvement in both the mean IPSS-QoL question by 43 % and mean ICIQ-N nocturia problem question by 53 %. Concomitant alpha-blocker use had no effect on the efficacy of desmopressin. The incidence of adverse events was low (2.2 %). Hyponatremia was not observed in any patient. The majority of patients and physicians rated the efficacy and tolerability of desmopressin as good/very good.Conclusions: Desmopressin is an effective and well-tolerated treatment for nocturia due to NP in patients with LUTS/BPH in daily practice under routine conditions.Methods: A German observational, multicenter, post-marketing surveillance study including men with LUTS/BPH and nocturia due to NP starting 3 months of desmopressin treatment. © 2014, Springer-Verlag Berlin Heidelberg.


The population with end stage renal disease (ESRD) is becoming increasingly older and more frail with a high burden of comorbidities, resulting in increasingly more complex therapy decisions. From an ethical perspective the four principles by Beauchamp and Childress have to be considered: dialysis is only justified when patient autonomy, nonmaleficence, beneficence and justice are guaranteed. With respect to beneficence, the quality of life is becoming more important than a mere prolongation of life expectancy. A change in paradigm is noticeable: dialysis is to be offered to patients who are likely to benefit, otherwise conservative management should be considered, thus turning dialysis withdrawal and dialysis withholding into appropriate options. Advance care planning and shared decision-making allow early and ongoing involvement of the patient, supporting patient autonomy and beneficence. This communicative and processual approach requires an appropriate time frame and special communication skills as well as conflict management. In the case of conservative management in ESRD best supportive care at the end of life ensures fulfillment of the individual patient needs, symptom control and palliative care. © 2016 Springer-Verlag Berlin Heidelberg


Hermann H.P.,Evangelisches Krankenhaus
Deutsche Medizinische Wochenschrift | Year: 2011

History and admission findings: A 49-year-old man with loss of performance, ventricular ectopy and left bundle branch block was referred for diagnostic workup. He had dysmorphic skeletal features with shortening and muscular atrophy of arm and leg and syndactylia. Investigations: Echocardiography revealed peculiar hypertrabeculation of left ventricular myocardium which was confirmed by cardiac magnetic resonance imaging. Therefore a diagnosis of non-compaction cardiomyopathy was made. Holter monitoring showed non-sustained ventricular tachycardia, coronary heart disease was excluded by coronary angiography. Treatment aund course: The patient received optimal heart failure drug therapy. Because of malignant ventricular ectopy a biventricular ICD system (CRT-D system) was implanted. Signs and symptoms of heart failure have been stable for four years (NYHA-class II). Repeated sustained ventricular tachycardia were terminated by ICD overstimulation. A history of inadequate ICD shocks was due to incompliance of the patient regarding beta blocker use. Conclusion: Non-compaction cardiomyopathy is a rare but characteristic cause of heart failure which is associated with potential malignant arryhthmias. Diagnosis is based on echocardiographic workup with typical features. However, because of its low prevalence and awareness deficits in the medical community, non-compaction cardiomyopathy probably is diagnosed too late and not frequently enough. © Georg Thieme Verlag KG Stuttgart.


Strecker J.-K.,University of Munster | Minnerup J.,University of Munster | Schutte-Nutgen K.,University of Munster | Gess B.,University of Munster | And 2 more authors.
Stroke | Year: 2013

Background and Purpose - Stroke-induced blood-brain barrier (BBB)-disruption can contribute to further progression of cerebral damage. There is rising evidence for a strong involvement of chemokines in postischemic BBB-breakdown. In a previous study, we showed that monocyte chemoattractant protein-1 (MCP-1)-deficiency results in a markedly reduced inflammatory reaction with decreased levels of interleukin-6, interleukin-1β, and granulocyte colony-stimulating factor after experimental stroke. With MCP-1 as one of the key players in stroke-induced inflammation, in this study, we investigated the influence of MCP-1 on poststroke BBB-disruption as well as transcription/ translation of BBB-related genes/proteins after cerebral ischemia. Methods - Sixteen wild-type and 16 MCP-1-/- mice were subjected to 30 minutes of middle cerebral artery occlusion. By injecting high molecular-tracer, we compared the degree of BBB-disruption after middle cerebral artery occlusion. Real-time polymerase chain reactions and Western blot technique were used to compare tight-junction gene expression, protein secretion, and BBB-leakage. Results - Here, we report that MCP-1-deficiency results in a reduced BBB-leakage and a diminished expression of BBB-related genes occludin, zonula occludens-1, and zonula occludens-2. Real-time polymerase chain reactions and Western blot analysis revealed elevated claudin-5-levels in MCP-1-/- animals. MCP-1-deficiency resulted in reduced infarct sizes and an increased vascular accumulation of fluorescein-isothiocyanate-albumin. Conclusions - The results of the study provide further insights into the molecular mechanisms of BBB-opening and may help to better understand the mechanisms of infarct development after cerebral ischemia. © 2013 American Heart Association, Inc.


Seelhoff A.,Evangelisches Krankenhaus | Schumacher B.,Evangelisches Krankenhaus | Neuhaus H.,Evangelisches Krankenhaus
Journal of Hepato-Biliary-Pancreatic Sciences | Year: 2011

Since the introduction of endoscopic sphincterotomy, stone clearance of the bile duct can be achieved by conventional endoscopic means in up to 90% of patients with stone disease. Several endoscopic therapies for difficult bile duct stones have been introduced. Laser therapy for stone fragmentation under direct visual control via the peroral insertion of a cholangioscope (POCS) in the bile duct has proven to be highly effective, further raising the success rate of endoscopic biliary stone clearance. However, conventional POCS has not gained wide acceptance because of several technical limitations such as fragility, impaired steerability and the need for two endoscopists. These limitations may be overcome with a newly developed single operator peroral cholangioscope, the SpyGlass ® Direct Visualization System. First clinical data of SpyGlass guided intraductal stone fragmentation with EHL or laser fibers report high safety and efficacy of the procedure. © 2011 Japanese Society of Hepato-Biliary-Pancreatic Surgery and Springer.

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