Sfincterul urinar artificial ContiClassic® este utilizat pentru a trata incontinența urinară din cauza deficienței intrinsece a sfincterului în cazuri precum incontinența după intervenția chirurgicală la prostată.

Sfincterul urinar artificial ContiClassic® combină simplitatea și succesul designului sfincterului urinar artificial convențional cu noi caracteristici inovatoare pentru a oferi rezultate mai bune de continere și durabilitate.

Prin actionarea pompei, manseta ce inconjoara uretra se dezumfla si ajunge in pozitia deschisa, permitand astfel urinei sa curga. Implantul ContiClasic®   are un sistem automat de inchidere a mansetei astfel; respectiv din momentul in care se actioneaza pompa pentru a deschide manseta si a incepe urinarea, sistemul incepe deja sa umfle la loc maseta ca urmare in aproximativ 90 de secunde manseta se inchide si uretra este compresata nepermițând trecerea urinei. 

Sfincterul ContiClassic® vă permite să vă controlați vezica urinară cu o pompă acționată manual pentru a comprima și elibera o manșetă în jurul uretrei. Implantul ContiClassic® este format din:

1. O manșetă gonflabilă plasată în jurul uretrei

2. Un rezervor pentru a stoca lichid și a menține presiunea în sistem și plasat în burtă

3. O supapă sau o pompă pentru controlul manșetei și plasată în scrot

Scopul AUS este de a reduce scurgerea de urină în timpul activităților precum strănutul, tusea, alergarea sau ridicarea greutăților.

Pentru mai multe informatii puteti vizita website-ul dedicat pacientilor la adresa incontinenta.genodynamic.ro

Rigicon oferă proteze peniene gonflabile din trei piese Infla10® pentru bărbații care au nevoie de intervenție chirurgicală pentru a trata disfuncția erectilă (DE). Infla10® este indicat pacienților care suferă de DE (impotență) cronică organică și candidați potriviți pentru implantarea protezei peniene.

Protezele Rigicon Infla 10® poarta dupa ele garantie internationala, astfel in cazul in care o persoana schimba tara de resedinta si apare o problema cu dispozitivul acesta va fi inlocuit gratuit (costurile de spitalizare nu sunt incluse) de catre reprezentantul local Rigicon. In cazul de fata reprezentantul Rigicon in Romania este compania Genodynamic SRL.

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Modelul Infla10® Anatomical eXpansion (AX), pe lângă extinderea convențională a circumferinței, oferă și extinderea lungimii. Infla10® este în prezent singura proteză peniană gonflabilă de pe piață care poate oferi extinderea lungimii cu cilindri acoperiți cu hidrofil. Cilindrii de expansiune în lungime au potențialul de a vă ajuta să beneficiați de anatomia penisului în întreaga sa capacitate. Protezele peniane gonflabile acționează ca un „expansor de țesut”, iar Infla10® AX va compensa lungimea suplimentară care poate fi câștigată după implantare. În plus, cilindrii AX au potențialul de a minimiza riscul de „defect Concorde” care poate apărea în cazul cilindrilor subdimensionați sau cu cilindrii de expansiune fără lungime. Consultați-vă medicul de specialitate pentru a înțelege dacă sunteți un candidat potrivit pentru implantarea unui cilindru AX.

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Modelul Infla10® NarrowBody™ este conceput special pentru pacienții cu anatomii mai mici sau compromise. Diametrul cilindrului NarrowBody™ este mai mic decât cilindrii X și AX, permițând pacienților cu camere erectile (corpii cavernosi) compromise/fibrotice să fie compatibili cu o proteză peniană gonflabilă.

Pentru mai multe informatii puteti vizita website-ul dedicat pacientilor la adresa implantpenian.genodynamic.ro

Vizient

Echolight Medical awarded Vizient contract to provide improved technology in bone density diagnostics.

Echolight Medical, an innovator in bone health technology, has been awarded a multi-year contract with VizientInc,, to make its Radiofrequency Echographic Multi Spectrometry (REMS) technology available at contracted pricing to its members, which represent more than half of the health care organizations across the United States. Widely used throughout Europe, REMS is a radiation-free technology delivered using a portable bone densitometer that can safely monitor key bone health indicators with greater frequency than other testing methods. Within minutes, REMS provides a patient’s bone health scores and an assessment of their future fracture risk.

REMS is the first clinically available method for the direct non-ionizing measurement of BMD at the femur and lumbar spine. Its portability allows for screening and monitoring of patients’ bone health at the point-of-care, improving early diagnosis and prevention of osteoporosis-related fractures.

“This is a major step in achieving our goal of delivering the most precise bone health assessment technology to clinicians at the point-of-care,” said Doug Tefft, Echolight Medical president. Echolight, founded in Italy in 2011, recently expanded its global reach to the United States with the opening of its Seattle headquarters in 2020. “Contracted pricing with Vizient will enable far more people increased access to state-of-the-art bone health assessment technology, at a time when there is a high risk of bone fracture among more than half of Americans age 50 and older.” Vizient’s diverse membership base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks, and non-acute health care providers. Vizient membership represents more than $100 billion in annual purchasing volume.

About REMS: Portable, diagnostic, radiation-free bone health densitometer – a safe, accurate, and cost-effective medical device elevating bone health awareness and treatment to mainstream medical care. Radiofrequency Echographic Multi Spectrometry (REMS) measures bone density; and reports T-score, Z-score, and a qualitative assessment of bone microarchitecture, independent of bone density, to predict future fracture risk – all provided in minutes. Learn more at echolightmedical.com.

Landis – Message & media

Vizient

R.E.M.S. IN THE ITALIAN NATIONAL GUIDELINES

New important recognition for Echolight: REMS technology (Radiofrequency Echographic Multi Spectrometry), the first ultrasound-based method to diagnose the osteoporosis and assess the risk of fragility fractures, is officially included in the Inter-Company Ministerial Guidelines for the correct identification and management of fragility fractures (Download Guidelines), presented at an event of the Fondazione Italiana Ricerca Malattie dell’Osso (FIRMO) on World Osteoporosis Day.

In a coordinated action between the Higher Institute of Health, the major Medical-Scientific Societies and Clinical Bodies, together with Patient Associations, the Guidelines “Diagnosis, risk stratification and continuity of care for Fragility Fractures” represent the most advanced recommendations of good clinical practice useful to guarantee patient care and assistance in compliance with the best standards of quality and appropriateness, as well as being unique in the national and international panorama.

REMS technology will also be the protagonist of a symposium during the first day of the XXI National Congress of the Italian Society of Osteoporosis, Mineral Metabolism and Skeletal Diseases (SIOMMMS), the Scientific Society involved in the problems related to skeletal and metabolic diseases, scheduled from October 28 to 30. The symposium, entitled “The new REMS ultrasound technique”, moderated by Professor Maria Luisa Brandi, President of FIRMO, will be an opportunity to present the experiences and clinical studies carried out over the years, which testify to the numerous advantages of the new method compared to X-ray, and its prospects for widespread use in clinical practice, thanks to the interventions of Dr Giovanni Adami – rheumatologist, University of Verona – Dr Carla Caffarelli and Prof. Stefano Gonnelli of the Department of Medical Sciences, Surgery and Neuroscience of the University of Siena.

[1] FIRMO – Fondazione Italiana Ricerca sulle malattie, SIOMMS – Società Italiana dell’Osteoporosi del Metabolismo Minerale e delle Malattie dello Scheletro, SIOT – Società Italiana di Ortopedia e Traumatologia, SIE – Società Italiana di Endocrinologia, SIMFER – Società Italiana di Medicina Fisica e Riabilitativa, SIMG – Società Italiana di Medicina Generale e delle Cure Primarie, SIR – Società Italiana di Reumatologia e FNOPI – Federazione Nazionale degli Ordini delle Professioni Infermieristiche.

Rigicon,Inc. announces that the U.S. Food and Drug Administration (FDA) has cleared Rigi10™ Malleable Penile Prosthesis for implantation into the corpora cavernosa of the penis for men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse.

Rigi10™ is easy to implant and easy to use. The Flexible Rod Technology™ enables higher bending angles with no spring-backs. Rigi10™ is offered in 5 different diameters and 2 sizes for a better fit to the patient’s anatomy.

Infla10^® is the next generation inflatable penile prosthesis designed with years of experience in urology. Infla10^® incorporates a hydrophilic coating on all external component surfaces to facilitate rapid and strong absorption of the solution on the device and promote easier device implantation. Innovative Rapid-Pump™ mechanism offers greater ease and speed for patients when inflating and deflating the prosthesis. Infla10^®AX version offers the patients anatomical girth and length expansion addressing concerns regarding post-operative penile shortening.

Penile Prosthesis is for treating erectile dysfunction, a condition affecting more than 200 million men annually worldwide, with nearly 50% of men over 60 suffering from moderate to severe symptoms.[1,2]

About Erectile Dysfunction

Erectile Dysfunction, or ED, is the inability to achieve or sustain an erection suitable for sexual intercourse. ED is actually a common male sexual disorder and may maintain a permanent course as some men cannot have any erection for the remaining part of their life. ED might have a deep impact on the quality of life and social relationships of the patient.

ED may be basically caused by various diseases and disorders including heart disease, diabetes, pelvic area damage due to surgery, accidents or radiation therapy, benign prostatic hyperplasia (BPH, which is non-cancerous enlargement of the prostate tissue), disorders associated with low testosterone levels, Parkinson’s disease, and other neurologic diseases.

About Malleable Penile Prosthesis (Semi-Rigid Penile Prosthesis)

Malleable penile prosthesis is a medical device that allows an impotent male to achieve an erection. The malleable implant consists of two rods that are always hard but pliable. All components are concealed within the body and cannot be seen from the outside. The penile implant cylinders reside in the penis on either side. No tissue is removed to place the rods; the rods simply occupy spaces that were previously filled with blood, when one was potent. The rods do not disrupt the flow of urine or ejaculate. The rods do not alter the sensation of the penis.

About Inflatable Penile Prosthesis (Three – Piece Inflatable Penile Prosthesis)

Inflatable devices, the most common type of penile implant used, can be inflated to create an erection and deflated at other times. Three-piece inflatable implants use a fluid-filled reservoir implanted under the abdominal wall, a pump and a release valve placed inside the scrotum, and two inflatable cylinders inside the penis. (Source:Mayo Clinic)

Penile implant surgery is considered a gold standard therapy for men with erectile dysfunction.

About Rigicon^®

Rigicon^® designs and manufactures innovative urological implants with 30 years experience on Urology. We focus on creating a comprehensive product portfolio for urologist(s) around the world. Our commitment is to deliver high quality and innovative urology products to our valued patients and physicians.

[1]US Census Bureau.

[2] Aytac IA et al (1996) – The likely worldwide increase in erectile dysfunction between 1995 and 2025and some possible policy consequences. BJUI, 84: 50-6.

European Approval Granted for Third-Generation System and All Previously Implanted, Second-Generation Systems

The EMBLEM S-ICD Systems are treatment options for patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature untouched, reducing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD System has begun in a small number of European centers with a broad European launch scheduled for early this summer.

In Europe, the EMBLEM MRI S-ICD System joins the growing family of ImageReady™ MR-conditional devices, all of which are labeled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the EMBLEM MRI S-ICD System as well as patients who previously were implanted with an EMBLEM S-ICD System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.

“These approvals give reassurance to physicians and their patients that they have access to any future MR scan needs, and underscores the Boston Scientific commitment to gain MR-conditional labeling on high-voltage devices that are being implanted today,” said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. “Further, the EMBLEM S-ICD System is a compelling treatment option for the majority of ICD-indicated patients that provides protection from cardiac arrest without invading the heart and blood vessels.”

The EMBLEM MRI S-ICD System also includes two new features, SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The SMART Pass technology will help ensure patients receive therapy from the device only when necessary by enhancing the INSIGHT™ Algorithm, which identifies and classifies a heart rhythm for effective arrhythmia treatment. This novel feature will also be added to previously implanted EMBLEM S-ICD Systems through a software update. The AF Monitor feature of the EMBLEM MRI S-ICD System is a new detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.

The company is actively pursuing U.S. Food and Drug Administration (FDA) approval of the EMBLEM MRI S-ICD System as well as MR-conditional labeling for previously implanted EMBLEM S-ICD Systems. Additionally, the global ENABLE MRI study, initiated earlier this year, is intended to support FDA approval for MR-conditional labeling across the company’s currently approved ICD and cardiac resynchronization therapy systems.

For more information on the EMBLEM S-ICD Systems visit www.sicdsystem.com.

In the U.S., the EMBLEM MRI S-ICD System is not available for sale.

 

The AXIOS System has been cleared for endoscopic management of pancreatic pseudocysts and certain types of walled-off pancreatic necrosis.¹ These conditions represent two types of pancreatic fluid collections (PFCs) that occur in 5-16 percent of patients with acute pancreatitis and 20-40 percent of patients with chronic pancreatitis.² While some of these PFCs are asymptomatic and self-resolving, others cause severe symptoms and require treatment.

Under endoscopic ultrasound (EUS) guidance, a physician can utilize the AXIOS System electrocautery-enhanced catheter to gain access to the PFC and deploy the AXIOS stent which facilitates drainage of the PFC by creating a temporary channel between the PFC and the gastrointestinal tract. The large flanges on each end of the lumen-apposing stent reduce the risk of leakage and migration. The stent – which is MRI compatible, fully covered, and self-expanding – is the only removable metal stent in the U.S. indicated for PFC drainage.

Although symptomatic PFCs can also be treated surgically, surgery has been associated with high rates of morbidity (7–37 percent) and mortality (6 percent).² Endoscopic solutions may offer a less invasive treatment option associated with shorter hospital stays, better physical and mental health of patients, as well as lower cost.³

“The AXIOS Stent and Electrocautery Enhanced Delivery System provide a simpler and faster treatment option for patients,” said Kenneth Binmoeller, M.D., California Pacific Medical Center, San Francisco, CA and the inventor of the AXIOS System. “We can now provide an endoscopic solution that provides immediate relief for these patients using one device in a single setting.”

“In our practice, the AXIOS System has improved the endoscopic treatment of PFCs and walled off necrosis,” said Todd Baron, M.D., professor of Medicine and director of Advanced Therapeutic Endoscopy, University of North Carolina Hospital, Chapel Hill, North Carolina. “The delivery system has improved our procedural efficiency by reducing procedure time and patient exposure to X-ray imaging. In addition, we believe that the large diameter stent design is helping to reduce the cost of care by decreasing hospital length of stay and the number of interventions needed to manage this complex disease.”

¹ The walled-off necrosis indication for the AXIOS Stent and Electrocautery Enhanced Delivery System is for PFCs containing less than 30 percent dead tissue.
² Safety and Efficacy of Endoscopic Ultrasound-Guided Drainage of Pancreatic Fluid Collections With Lumen-Apposing Covered Self-Expanding Metal Stents. Shah RJ, Shah JN, Waxman I, Kowalski TE, Sanchez-Yague A, Nieto J, Brauer BC, Gaidhane M, Kahaleh M. Clin Gastroenterol and Hepatol 2014 Oct 5 http://www.ncbi.nlm.nih.gov/pubmed/25290534
³ Varadarajulu et al, Equal Efficacy of Endoscopic and Surgical Cystogastrostomy for Pancreatic Pseudocyst Drainage in a Randomized Trial. Gastroenterology 2013; 145:

For more information, please visit the AXIOS™ System product page here. Or follow Boston Scientific Endoscopy on Twitter at @bsc_endoscopy.

Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/72234510-boston-scientific-axios-stent-and-delivery-system/

 

New catheters and software enhancement expand capabilities of high-definition Rhythmia™ Mapping System.

MARLBOROUGH, Mass., May 3, 2016 /PRNewswire/ — Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for two catheters that can be used with the Rhythmia™ Mapping System. The IntellaNav™ XP and the IntellaNav MiFi™ XP navigation-enabled ablation catheters – designed to map and ablate – were approved to treat Type I atrial flutter, an abnormal rhythm of the upper chambers of the heart. These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market. Along with the immediate launch of the catheters, the company is also releasing a software enhancement for the Rhythmia Mapping System.

“By combining these new magnetic navigation-enabled catheters with our high-density, high-resolution Rhythmia Mapping System, we can create enhanced maps that help diagnose arrhythmias and improve guidance during cardiac ablation procedures,” said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. “With these approvals, we continue the expansion of our electrophysiology product offerings, further demonstrating our commitment to help electrophysiologists provide the highest quality of care for their patients.”

Unlike conventional cardiac mapping systems, the Rhythmia Mapping System rapidly and automatically generates three-dimensional images of any chamber of the heart to help diagnose, locate and treat the source of rhythm abnormality. The Software Version 1.4 mapping system update improves the speed and quality in which the images are acquired using a variety of therapeutic and diagnostic catheters, including the IntellaNav XP and IntellaNav MiFi XP catheters. The software update also provides advanced editing capabilities, allowing for detailed visual enhancements of the maps.

Both of the newly approved IntellaNav XP catheters feature magnetic sensors which track the location of the catheter while delivering radiofrequency energy into the heart muscle, creating heat to destroy a small area of the tissue responsible for the abnormal heart rhythm. The IntellaNav MiFi XP catheter also provides increased accuracy and signal clarity via mini-electrode technology which delivers a highly localized signal closely reflecting what is happening at the tip in real-time during the ablation procedure.

MARLBOROUGH, Mass., Feb. 26, 2015 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announces 510(k) clearance and the first cases of the SpyGlass DS Direct Visualization System used for cholangioscopy and pancreatoscopy procedures. Built on the technology of the original SpyGlass System, the new SpyGlass DS System is designed to optimize procedural efficiency and productivity with improved ease of setup, ease of use and image quality.

More than one million people worldwide undergo endoscopic retrograde cholangiopancreatography (ERCP) procedures each year to diagnose and treat diseases and conditions of the liver, gallbladder, pancreas and bile ducts.¹ In the event that x-ray imaging is not sufficient to make a definitive diagnosis or therapeutic intervention requires direct visualization, cholangioscopy or pancreatoscopy may be performed. Cholangioscopy is the examination of the bile ducts using an endoscope to enable direct visualization of the biliary tree during ERCP while pancreatoscopy is the examination of the pancreatic ducts. Direct visualization of the bile and pancreatic ducts during ERCP can help obtain biopsy specimens, lead to the diagnosis of abnormalities, and guide stone therapy.²

“I’m extremely pleased with the overall functionality of the new SpyGlass DS System,” said Robert Hawes, M.D., FASGE, The Center for Interventional Endoscopy at Florida Hospital Orlando. “It was quick and easy to set up (‘plug and play’), the image quality and stability excellent and the four-way tip deflection intuitive. The system now enables endoscopists with ERCP expertise to perform cholangioscopy with or without intervention. My expectation is that this technology will increase our ability to diagnose and treat pancreatobiliary diseases and reduce the number of repeat ERCPs.”

Launched in 2007, the original SpyGlass System helped re-establish cholangioscopy and pancreatoscopy as a valuable diagnostic and therapeutic procedure by allowing a single physician to perform the procedure as well as guide devices to examine, diagnose and treat conditions such as gallstones and suspected malignancies of the biliary tree and pancreas. The new SpyGlass DS System builds on this technology with enhanced features to further improve visualization and help simplify the procedure. The system consists of a fully integrated SpyScope™ DS Access and Delivery Catheter, and a single-use scope to eliminate probe reprocessing and image degradation over multiple uses. The integrated digital sensor provides superior imaging, far greater resolution and a 60 percent wider field of view than the first generation system. In addition, the SpyGlass DS System offers physicians an integrated controller that fits on a standard ERCP cart for improved accessibility and ‘plug and play’ setup, helping to reduce procedure time.

“Early detection is critical to improving outcomes in patients suffering from difficult pancreatico-biliary diseases, such as pancreatic cancer,” said David Pierce, senior vice president and president, Endoscopy, Boston Scientific. “The new SpyGlass DS System can be performed as an extension of any ERCP procedure, enabling physicians to diagnose and treat more of their patients effectively and efficiently. Boston Scientific is proud to bring single-operator cholangioscopy to a new level of treatment.”