Patent foramen ovale (PFO) is a common heart condition in adults. Closure with a septal occluder device is a safe, well-established treatment option with excellent clinical outcomes. One rare complication of percutaneous PFO closure is embolization of the device to the heart chambers or distal vasculature. Most device migrations are recognized during or shortly after implantation. While many endovascular retrievals of migrated devices are successful, there are still a high percentage of surgical interventions performed. We report a case of a septal occluder device that embolized to the abdominal aorta and was discovered 7 days after implantation. Endovascular techniques with a snare and endobronchial forceps were used to retrieve the device safely ...
We describe a case of 43-year-old man with transcatheter closure of atrial septal defect (ASD) with the Amplatzer Septal Occluder that was embolized to the main pulmonary artery. Echocardiography could not identify the occluder device at the interatrial septal position. Tomography confirmed its dislocation (Figure 1). Silent device dislodgement which is a rare complication in terms of being asymptomatic was managed immediately. It was removed via pulmonary arteriotomy (Figure 2A and B) and the ostium secundum ASD without inferior rim was closed by using an autologous pericardial patch on total cardiopulmonary bypass. His postoperative period was uneventful.. Key words: Device Removal; Heart Septal Defects, Atrial; Septal Occluder Device ...
Results Thirty patients underwent LSA embolization during TEVAR. Six CCEs in 6 patients were performed from June 2013 to November 2013, while twenty-four CAEs in 24 patients were performed from December 2013 to March 2016. Technical success was achieved in all patients in both groups. No embolization-related complications or type II endoleaks from LSA were recorded during the follow-up period in all patients. In both groups, all embolic materials were detected in the proximal portion of the LSA from the LSA orifice to the vertebral artery origin and no vertebral artery occlusions were detected. The mean compression ratio of AVP II was 58 ± 5.9% of predicted length of standard procedure. In the CAE group, one AVP II was sufficient to achieve complete LSA occlusion in all patients. On the other hand, multiple coils (10.2 ± 2.7) were used in the CCE group (P , .01), resulting in a significantly lower cost incurred in the CAE group (CAE: 129,000 JPY vs. CCE: 639,600 ± 140,060 JPY; P , .01 ...
Although surgical repair or replacement is the gold standard for treatment of prosthetic paravalvular leakage, it carries a high morbidity and mortality risk, and some patients are poor surgical candidates. The percutaneous closure of such defects is an attractive alternative to surgery, and different devices are being used for this purpose. Afemorofemoral wire loop is usually constructed to deliver the closure device. In our case, a prosthetic mitral paravalvular leak was successfully closed with use of the Amplatzer® Duct Occluder II, via retrograde approach under the guidance of fluoroscopy and trans esophageal echocardiography, without the use of a wire loop. ...
This independent 106 pages report guarantees you will remain better informed than your competition. With over 170 tables and figures examining the Cardiac Septal Occluder Sales market, the report gives you a visual, one-stop breakdown of the leading products, submarkets and market leaders market revenue forecasts as well as analysis to 2022.. In conclusion, Cardiac Septal Occluder Sales market 2017 report presents the descriptive analysis of the parent market based on elite players, present, past and futuristic data which will serve as a profitable guide for all the Cardiac Septal Occluder Sales industry competitors.. Our expert research analysts team has been trained to provide in-depth market research report from every individual sector which will be helpful to understand the industry data in the most precise way.. About Us:-. MarketInsightsReports provides syndicated market research report to industries, organizations or even individuals with an aim of helping them in their decision making ...
To our knowledge this is the first description of aortic root perforation by a septal occluder in a patient with Marfan syndrome. There are only a few cases that report destruction of aortic segments after placement of closure devices in patients with patent foramen ovale (PFO), patent ductus arteriosus (PDA) or ASD [4-7]. Perforation is a rare event, occurring in approximately 0.1% of all cases, indicating closure devices are generally safe. The mechanism of perforation is not well understood but it might be related to the absence or presence of the anterosuperior and posteroinferior rims of the atrial septum where the closure device is fixed in position [8, 9]. Interestingly perforations are observed uniquely in the anterosuperior wall and the adjacent aorta [10].. In patients with an altered connective tissue, the reason for dislocation of closure devices might be different. Thus far, we know that the affected protein Fibrillin in Marfan syndrome, plays a crucial role in maintaining the ...
A 4 year old girl was admitted with cyanosis after exercise. Physical examination found a continuous murmur which was loudest in the upper right parasternal region. The ECG was normal. Transthoracic echocardiography revealed mild right ventricular and atrial dilatation; it also revealed a fistula originating from the left main coronary artery (LMCA), rounding the ascending aorta and left atrium, and emptying into the right atrium. Ascending aorta angiography showed the presence of an aneurysmal fistula originating from the left main coronary artery and draining into the right atrium. The diameter of the fistulous orifice was 3.0 mm (upper panel, middle column).. A 5 French JL3.0 angiography catheter was introduced into LMCA. Within the catheter a 0.014 inch guiding wire was inserted into left main coronary artery and crossed the fistula into the right atrium. The guiding wire was caught in the right atrium by the Amplatz goose neck snare, and passed through a femoral vein. Over the wire a ...
An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques.. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).. However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol. ...
The Amplatzer Duct Occluder can accommodate large PDAs with a single device-which can aid in minimizing the complexity of the procedure.
Physicians have been performing catheter-based procedures in the heart to make diagnoses and treat heart conditions for many years. Catheter-based closure of an ASD involves the placement of a permanent implant, such as the GORE® CARDIOFORM Septal Occluder, using a minimally invasive procedure.. The GORE® CARDIOFORM Septal Occluder is intended for the closure of an ASD using cardiac catheterization. It is a permanent implant consisting of a wire frame covered with a thin ePTFE membrane. The wire frame is made of a platinum-filled nickel-titanium (Nitinol) alloy. The ePTFE material, invented and manufactured by Gore has been used in open-heart surgery for more than 35 years with a history of proven safety in medical implants.. ...
PURPOSE: Deformable image registration (DIR) is essential for many image-guided therapies. Recently, deep learning approaches have gained substantial popularity and success in DIR. Most deep learning approaches use the so-called mono-stream high-to-low, low-to-high network structure and can achieve satisfactory overall registration results. However, accurate alignments for some severely deformed local regions, which are crucial for pinpointing surgical targets, are often overlooked. Consequently, these approaches are not sensitive to some hard-to-align regions, e.g., intra-patient registration of deformed liver lobes. METHODS: We propose a novel unsupervised registration network, namely full-resolution residual registration network (F3RNet), for deformable registration of severely deformed organs. The proposed method combines two parallel processing streams in a residual learning fashion. One stream takes advantage of the full-resolution information that facilitates accurate voxel-level ...
Purpose Endovascular vessel occlusion may be necessary to treat a variety of neurovascular pathologies such as pseudo-aneurysms and giant aneurysms, iatrogenic and penetrating vascular injuries and direct arteriovenous fistulas of the carotid and vertebral arteries. Endovascular devices commonly used for such deconstructive approaches include detachable balloons, micro-coils, liquid embolic agents or the Amplatzer vascular plug. In the recent months, a new device has become available for arterial occlusion that may have unique applications in neurovascular disease. The Micro Vascular Plug (MVP, Reverse Medical, Irvine, CA) has been designed for vessel occlusion through targeted embolization. It consists of electrolytically detachable ovoid Nitinol exoskeleton. The proximal portion of the plug is partially covered with PTFE (polyetrafluoroethylene) to ensure prompt and complete cessation of blood flow. The device comes in two sizes (3 mm and 5 mm); is fully re-sheathable and can be deployed ...
Dr. Edwards is board certified by the American Osteopathic Board of Surgery and is also a member of the American College of Phlebology. Dr. Edwards has been providing vein care in southwestern Georgia since 2006 and is the Director of the Center for Vein Care and Surgery of Horizons Diagnostics, LLC. Our vein center is accredited by the Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL). Dr. Edwards is pleased to offer the Venefit® Closure Procedure (formerly VNUS Closure), an alternative treatment option to traditional vein stripping surgery of the legs. Over 3000 Closure procedures have been successfully performed with excellent results. The Closure procedure is a clinically proven, minimally invasive way to treat venous reflux, the underlying cause of varicose veins of the legs, with little or no pain. Closure patients can return to everyday activities within a day. The Closure procedure is performed in the doctors office and is covered by most insurance ...
I have now used the Gore Helex Device in more than 250 patients with excellent results. The complication rate is low and the closure rate is high, said Ziyad M Hijazi, director, Rush Center for Congenital and Structural Heart Disease, professor of Pediatrics and Internal Medicine, and section chief Pediatric Cardiology at Rush University Medical Center in Chicago, USA. When treating an atrial septal defect, if the Gore device is appropriate, I will use it right away as the material is very soft and conforms to the shape of the hole. The Gore-TEX material is key.. The Gore Helex Septal Occluder is a device made mostly of Gore-TEX patch and minimal metal frame. It poses a low risk of thrombus formation on the disc, atrial arrhythmia complications from the device, and no reported cases of injury to the heart wall resulting in perforation, a potentially life-threatening complication, stated John F Rhodes, associate professor in Pediatrics and Medicine at Duke University, chief of the Childrens ...
US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval has been granted for the Carag Bioresorbable Septal Occluder (CBSO).
The report titled Global Medical Occluder Market is one of the most comprehensive and important additions to QY Researchs archive of market research studies. It offers detailed research and analysis of key aspects of the global Medical Occluder market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the global Medical Occluder market. Market participants can use the analysis on market dynamics to plan effective growth strategies and prepare for future challenges beforehand. Each trend of the global Medical Occluder market is carefully analyzed and researched about by the market analysts. The market analysts and researchers have done extensive analysis of the global Medical Occluder market with the help of research methodologies such as PESTLE and Porters Five Forces analysis. They have provided accurate and reliable market data and useful recommendations ...
AGA Medical commences enrollment in AMPLATZER Cardiac Plug clinical trial AGA Medical Holdings, Inc. Dr http://sildenafil-100mg.org/ . William Nicholson, an interventional cardiologist and structural heart... ...
A unidirectional flow heart valve includes a passageway having an inlet side and an outlet side. A disk occluder is disposed within the passageway. The disk occluder has a closed position wherein the disk occluder occludes fluid flow through the passageway and an open position wherein the disk occluder permits fluid flow through the passageway. A fulcrum causes the disk occluder to pivot off center between the open and closed positions. An electromagnetic control mechanism forces the disk occluder to remain closed when energized until a predetermined net pressure is reached against the disk occluder. When the electromagnetic control mechanism is either selectively deenergized or the force on the occluder disk is greater than the holding force of the electromagnetic control mechanism, the disk occluder is released from the closed position to pivot on the fulcrum in response to fluid pressure.
According to recent Gore announcement, their PFO closure device showed a statistically significant reduction in stroke recurrence in the primary intent-to-treat analysis. Read the full Gore press release here...
The Amplatzer Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD). See full indication.
Spielmann Occluder An opaque occluder on handle for cover testing. Eye movements of the occluded eye can be monitored during the test. Occlusion is | 20/300.
We offer a selection of hand-held occluders including white, long and multi-pinhole occluders made of tough plastic that will not break or shatter.
The PFO, present in the heart of every developing fetus, typically closes after birth. But that was not the case for Heidi. While many people with a PFO never experience symptoms or complications, the condition can potentially allow dangerous clots to travel up to the brain and cause a stroke. The PFO Occluder device we placed closed the hole in Heidis heart and reduced her risk of having recurrent strokes. Today, Heidi feels at ease, knowing her risk of having more strokes is low. She sees her diet as a form of medicine. She eats healthier foods that make her feel good, and she enjoys all of her normal activities. She believes its important to move forward-to believe in the power of healing and live life to its fullest. *Heidi was the first patient to receive this device that had been in clinical trials prior to her procedure. ...
Eye Occluder 9.5 Single Ended Paddle Style - $15 No Tax - Buy Professional Quality Eye Occluders. Save When Ordering 5 or More. Easy online ordering from Cascade HealthCare Products Inc.
Occluders are packaged in a convenient (1) pair tray. Each occluder is individually sterile and pre-loaded on a high quality disposable inserter.
LLP was incorporated on 2018 and no forms filed ever since for not doing any business, as part of closure procedure, is it required file ITR and get the statement of accounts from CA.. Click here to view / answer Share it on ...
BioVentrix announces that Gregg Stone, MD, of Mount Sinai Health System was named co-principal investigator of its ALIVE pivotal trial.
An expandable lumen cannula which includes an elongate tube having a proximal end, a distal end, an intermediate flexible region, and a lumen therebetween. The cannula further includes a balloon occluder mounted on the distal end of the tube. The intermediate flexible region of the tube further includes an elongate generally cylindrical balloon disposed circumferentially about the flexible region which, upon inflation, expands the luminal diameter of the intermediate region. First and second inflation ports are in fluid communication with the balloon occluder and the cylindrical balloon. The cannula may optionally include a cardioplegia port disposed within the distal region of the tube, proximal the balloon occluder and distal the generally cylindrical balloon. Methods of using such a cannula are also disclosed, particularly to provide cannulation through a minimally invasive port incision, and to thereafter displace the tissues and organs adjacent an intercostal access port upon inflation and
We introduce the new non-line-of-sight imaging problem of imaging behind an occluder. The behind-an-occluder problem can be solved if the hidden space is fla...
The Occlutech PDA Occluder is an ideal occluder for closing the defects in morphologically different configurations ranging from small tunnel shaped ducts to large oval shunts. ...
An occlusion method and apparatus. The occluder includes a elastically deformable members and a jacket. The elastically deformable members are secured in spaced relation and extend in arcuate conformation therebetween. The jacket covers at least a portion of the elastically deformable members. The elastically deformable members are configured to become compressed upon application of a force and to recover the arcuate conformation upon removal of the force to occlude a site.
Correct sizing of the ostium is a crucial step in left atrial appendage occlusion procedures. We hypothesize that area-derived and perimeter-derived diameters from 3D transesophageal echocardiogram can facilitate this step of the procedure.
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.. A co-primary objective is to demonstrate that medical management plus closure with the study device reduces the risk of new brain infarct compared to medical management alone ...
OBJECTIVE: Atrial fibrillation puts patients at significant risk for embolic stroke originating from the left atrial appendage. Few means are available for safe, effective, and durable left atrial appendage occlusion. A new clip device was evaluated with regard to safety and effectiveness for epicardial left atrial appendage occlusion. METHODS: Patients with atrial fibrillation undergoing elective cardiac surgery through a median sternotomy were enrolled for concomitant epicardial clip placement. Early postoperative and 3-month follow-up computed tomography studies were used to assess clip stability and left atrial appendage perfusion. RESULTS: From September 2007 to December 2008, 34 patients underwent successful clip placement. No device-related complications occurred. Operative mortality was 8.8% and not study or device related. Deployment was rapid, and left atrial appendage occlusion was confirmed by intraoperative transesophageal echocardiography in all patients. In addition to excellent ...
The percutaneous closure of a single secundum atrial septal defect (ASD) under transesophageal echocardiography guidance as an accepted alternative to the transcatheter closure with fluoroscopy has been proven. However, the technique has not been routinely used. This study was to present and share our experience in comparing the clinical outcomes of the percutaneous and intra-operative device closure (IODC) of atrial septal defects without fluoroscopy. From January 2013 to December 2016, 103 patients with maximum diameters of ASD of less than 30 mm were allocated to groups taking either the percutaneous closure of atrial septal defects approach (PASD group, n = 53) or the intra-operative device closure approach (IODC Group, n = 50). They were operated on using the minimally invasive Amplatzer duct occluder under the guidance of transesophageal echocardiography without cardiopulmonary bypass. Echocardiography was performed to obtain an en face view of the ASD and important surrounding structures before
A 12 year old boy underwent percutaneous closure of a secundum atrial septal defect under general anaesthetic. He had been pretreated with aspirin and had 100 U/kg of heparin at the start of the procedure. A transoesophageal echocardiogram (TOE) showed acceptable margins and closure was attempted with a 16 mm Amplatzer atrial septal occluder (AGA Medical Corporation, Golden Valley, Minnesota, USA). The device position was unstable because of a floppy posterior margin and the device was retrieved. Successful closure was achieved with a 20 mm device although retrieval and repositioning were required on five occasions.. After release of the device a pedunculated 8 mm thrombus attached to the centre of the left sided disk was seen on TOE (video 1) (to view video footage visit the Heart website-http://www.heartjnl.com/supplemental). There was particular concern about embolisation given the highly mobile appearance of the clot. Treatment with abciximab according to the adult guidelines (bolus of 0.25 ...
Occlutech, a leading innovator of implants to treat structural heart disease, has obtained European CE mark approval for its Perimembranous Ventricular Septal Defect (PmVSD) occluder. The device is a specifically designed implant indicated for the minimally invasive closure of perimembranous ventricular septal defects.. Tor Peters, CEO of the Occlutech Group, commented: The Occlutech PmVSD Occluder is the latest addition to our VSD occluder program.. We are happy and proud to be able to provide patients and cardiologists with this innovative product as we expect our VSD occluder offering to provide improved therapeutic options for this patient population.. Perimembranous VSDs represent 70 - 80 % of all VSDs. Ventricular Septal Defects are the most common congenital cardiac abnormalities and they account for 30-60% of all congenital heart defects in newborns (about 2-6 VSDs per 1,000 births).. Occlutechs PmVSD Occluder consists of a flexible nitinol wire mesh with shape-memory properties ...
Transcatheter PDA closure is now a well-established procedure, that is, performed frequently (1-6), with conventional surgery generally reserved for patients with a large duct or symptomatic preterm infants. A number of devices and techniques have been in clinical use with varying degree of popularity and success since Porstmann et al. (12)introduced the Ivalon plug nearly three decades ago. The extensively investigated Rashkind PDA occluder was once widely accepted, but its high cost, the need for a relatively large transvenous sheath, a late incidence of residual shunt of up to 15% to 20% and the risk of stenosis at the origin of the LPA with the use of the 17 mm device led to the search for alternatives (13). Ironically, the Gianturco coils, though not purpose-designed for closure of PDA, are currently among the most widely used techniques due to its low cost, ease of delivery using small 4F and 5F conventional catheters and, more importantly, its high closure rate, approaching 98% to 100% at ...
Rationale The utility of patent foramen ovale (PFO) closure for secondary prevention in patients with prior cryptogenic stroke is uncertain despite multiple randomized trials completed to date. Aims The Gore REDUCE Clinical Study (REDUCE) aims to establish superiority of patent foramen ovale closure in conjunction with antiplatelet therapy over antiplatelet therapy alone in reducing the risk of recurrent clinical ischemic stroke or new silent brain infarct in patients who have had a cryptogenic stroke. Methods and design This controlled, open-label trial randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus patent foramen ovale closure (with GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder) or antiplatelet therapy alone ...
Introduction. There is a concern about release of nickel and titanium after implantation of nitinol-containing devices. Objective. To evaluate serum nickel and titanium release after implantation of Amplatzer occluder. Materials and methods. In 38 pediatric patients with no history of nickel sensitivity, blood samples were drawn 24 hours before and 24 hours, 1, 3, 6, and 12 months after implantation. Nickel and titanium concentrations were measured by atomic absorption spectrophotometry. Results. The median serum nickel level which was 0.44ng/mL before the implantation increased to 1.01ng/mL 24 hours after implantation and 1.72ng/mL one month after implantation. The maximum level was detected 3 months after implantation, with a median level of 1.96ng/mL. During follow-up, the nickel levels decreased to those measured before implantation. Serum nickel levels at the 24th hour, 1st month, and 3rd month following implantation were found to have increased significantly. No patients showed a ...
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Sinus of Valsalva aneurysm, usually a congenital anomaly, almost always ruptures into the right sided cardiac chambers, causing a left-to-right shunt with profound haemodynamic consequences. With the availability of the current genera- tion of devices and hardware, transcatheter closure has gradually replaced the surgical route. To date, most closures have been performed using an Amplatzer duct occluder (ADO). Here, we report the case of a 21 year-old male where a very large (18 mm) rupture of a sinus of Valsalva aneurysm from non-coronary cusp to right ventricle was closed by a percutaneous approach using a 20/18 mm Cocoon duct occluder (CDO; Vascular Innovations, Nonthaburi, Thailand ...
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In assessing the value of FFR, the studys investigators defined management strategies for patients based on angiography results before performing FFR, and then made a final treatment strategy decision after performing FFR. Results showed that management strategy reclassification after performing routine FFR was high and that FFR is safe to use in ACS patients, indicating a management strategy guided by FFR safely leads to changes in physician decision making.. Researchers also assessed the impact of a LAAO in patients with atrial fibrillation and intracerebral hemorrhage versus patients who received standard medical therapy.. The LAAO in atrial fibrillation and intracerebral hemorrhage study found that patients with AF and a prior intracerebral hemorrhage who were treated with a St Jude Medical LAAO device had a lower risk of ischaemic stroke, major bleeding and all-cause mortality compared to patients treated with standard care, suggesting that LAAO offers a major clinical benefit.. Patients ...
The limited number of patients with identified Hughes-Stovin syndrome has precluded the initiation of controlled studies of the management of patients with pulmonary arterial aneurysms [3]. Corticosteroids, alone or in combination with an immunosuppressant, are generally considered first-line therapy [4]. Surgical resection has been the traditional treatment of choice when the risk of lethal hemoptysis necessitates more definitive therapy. Total pneumonectomy or lobectomy has been performed with some successful results [5].. The high morbidity associated with surgery and the frequent bilaterality and multifocality of the pulmonary artery aneurysms make transcatheter embolization an attractive alternative to surgery in most cases. To our knowledge, few patients with Hughes-Stovin syndrome have been treated by performing embolization of a pulmonary arterial aneurysm with the use of several agents, including steel coils, Ethibloc, and isobutyl cyanoacrylate, an epoxy [4, 6, 7].. This is the first ...
Numerous transcatheter PFO closure systems are commercially available or under investigation. Some of the double umbrella devices leave a relatively large amount of foreign material in the atria, which can lead to thrombus formation on the device (9,10). We reported in a study with 1,000 patients that the incidence of thrombus formation is 2% (9). Furthermore, distortion of the septum due to a wire might be the cause of atrial fibrillation in some patients.. One of the advantages of the SeptRx device is the minimal material in the left atrium. So far, no thrombus formation has occurred, and the unique design of the device might help to minimize chronic complications such as thrombus formation or atrial fibrillation. A few other new devices are designed to minimize the incidence of thrombus formation. The BioSTAR device (NMT Medical, Boston, Massachusetts), reported by Mullen et al. (11), is a bioabsorbable septal repair device that is mostly replaced with healthy native tissue. According to the ...
Atrial septal defect (ASD) is a condition that requires early intervention because of the consequences over the right-side heart. Chronic atrial …
Through nonclinical testing, the AMPLATZER™ Septal Occluder has been shown to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.O tesla for a 20-minute exposure to a Bl of 118 μT. The AMPLATZER™ Septal Occluder should not migrate in this MR environment. The nonclinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.. In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.. MR image may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.. ...
Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience. Santoro G, Castaldi B, Cuman M, Di Candia A, Pizzuto A, Sirico D, Cantinotti M, Garibaldi S, Pak V, Di Salvo G.Int J Cardiol. 2020 Nov 18:S0167-5273(20)34152-8. doi: 10.1016/j.ijcard.2020.11.029. Online ahead of print.PMID: 33220363 Take Home Points: The GORE® Cardioform ASD Occluder device (WL Gore & Associates, Flagstaff, AZ) was recently approved by the USA Food and Drug Administration in June 2019 for closure of ostium secundum atrial septal defects (up to 35 mm in diameter). This is a Prospective observational study at two Italian Pediatric Cardiology centers (43 patients) using the Gore Cardioform ASD occluder from January to June 2020. Device deployment was successful in 97.7% patients with complete closure rate of 92.9% at 1 month follow up (all residual shunt was reported trivial). Commentary from Dr. Varun Aggarwal MBBS MD (University of Minnesota Masonic Childrens ...
This advisory, published at the end of July in Neurology, is an update from the 2004 AAN guideline on secondary stroke in PFO patients, which concluded that the optimal therapy for this patient population was unknown. Additional studies prompted the AAN to analyse whether percutaneous closure of PFO is superior to medical therapy alone and anticoagulation is superior to antiplatelet therapy for the prevention of recurrent stroke in patients who have had a cryptogenic ischaemic stroke or transient ischaemic attack (TIA).. In order to update the 2004 guidelines, a panel of neurologists, cardiologists, and an internist with expertise in stroke and PFO who had no financial conflicts performed a literature search on the subject. Messé et al identified three key studies on percutaneous PFO closure. The first was CLOSURE I, a multicentre randomised, open-label trial of percutaneous closure, which compared the StarFlex device (NMT Medical) with medical therapy alone in adult patients with PFO and a ...
St. Jude Medical Announces First Implant in Pivotal Phase of Clinical Trial Evaluating AMPLATZER Cardiac Plug for the Prevention of Stroke in Patients with Atrial Fibrillation ST. PAUL,
The Food and Drug Administrations (FDA) Circulatory System Device Panel met on Oct. 8, 2014, for the third time to discuss Boston Scientifics application for approval of the WATCHMAN device, a left atrial appendage closure device. The panel voted six to five with one abstention that the benefits outweighed the risks of the device for the specified patient population, a far closer vote than those of previous panels. The close nature of the vote reflected the panels concerns regarding the proposed label indication. Discussion throughout the day conveyed panel members concerns that this be an option only as a second-line therapy for a select group of patients and the need to include this as part of the label indication. Other concerns included the need for sufficient patient education regarding the benefits and risks of the WATCHMAN device, as well as the sufficiency of the proposed post approval study should the device be approved.. The major debate of the day was whether the new data from the ...
Coronary artery disease, percutaneous coronary intervention, cardiac risk factor management, vascular biology, cardiac disease and diving medicine, closure of PFO and ASD, left atrial appendage occlusion ...
Atrial fibrillation (AF) is a common type of arrhythmia that increases significantly the risk of blood clots in the heart and of stroke. Therefore, stroke prevention is a key goal of AF treatment. In the past, patients were required to take anticoagulants for the remainder of their life, to regularly the monitor international normalized ratio (INR) of prothrombin time (PT), and to avoid possible negative interactions with various drugs and foods. Left atrial appendage occlusion (LAAO), a novel device and technique, was thus developed for AF patients with contraindications to anticoagulants and a high risk of bleeding ...
Transthoracic echocardiography is a safe alternative for assessment and guidance of transcatheter closure of secundum atrial septal defect in children
The invention provides an occluder device according to claim 1. Preferred embodiments are defined in the dependent claims. More generally the present disclosure describes solutions to the above problems with the prior art. By using a braided tubular fabric made from a shape memory material (e.g., Nitinol) such as that formed by the methods of fabrication, molding and heat treatment and delivery as described by patents 6,123,715 by Amplatz and 5,725,552 by Kotula et al., embodiments of the present disclosure may provide a flexible, low profile vascular occlusion device having a large volume filling capability and high metal content for faster occlusion. As in the referenced patents, braided tubular metal fabric having an expanded preset configuration and an elongated collapsed reduced diameter configuration for delivery through a catheter to a treatment site is shaped to create an occlusion of an abnormal opening in a body organ or vessel. The woven metal fabric has a memory property, whereby the ...
Introduction: Peripheral artery disease (PAD) including critical limb ischemia (CLI) leads to increased risk of myocardial infarction even in the absence of coronary artery disease (CAD). It has been postulated that the CLI muscles release substances systemically that lead to coronary artery endothelial dysfunction and reduced nitric oxide (NO) bioavailability. We have recently shown that administration of the hydrogen sulfide (H2S) prodrug, SG-1002, increases NO bioavailability in normal and heart failure patients.. Hypothesis: We investigated the effects of SG-1002 on coronary artery vascular function in a clinically relevant swine model of CLI.. Methods: CLI was generated in Yucatan miniswine by placement of an Amplatzer vascular plug deployed within a Viabahn stent in the proximal external iliac artery. Treatment with placebo (n=7) or SG-1002 (1600 mg PO, n=7) was initiated at 7 days post-CLI and continued for 35 days. On days 0 and 42 circulating levels of NO and H2S measured as nitrite ...
Device Closure: Percutaneous device closure is the non-surgical procedure for the treatment of ASD, VSD & PDA in selected patients of these birth defects. ...
An occlusion device includes a flexible section formed by a wire connector. The flexible wire connector gives the occlusion device improved torque and flexure characteristics, which allows the device to better conform to the contours of the heart.
Click here to see original video.Patent ductus arteriosus (PDA) represents the persistence of a communication between the aorta and pulmonary artery which is very essential for the fetus and normally shuts down in the majority within 24 hours of birth. This results in passage of pure blood from the aorta into the lungs and again depending on the size of the defect could be asymptomatic, present with recurrent lung infections and heart failure. Percutaneous closure is the treatment of choice unless it is accompanied by other birth defects which require surgery. Percutaneous closure is done with coils or devices. In small PDAs coil may suffice larger defects are preferably closed with devices. Through a catheter a device or a coil is positioned in the PDA resulting in closure of the duct.
Our study shows that a significant improvement in exercise capacity and decrease in RV size occur rapidly after percutaneous ASD closure in adults considered asymptomatic or mildly symptomatic. This benefit is observed irrespective of age or magnitude of shunt and raises questions as to whether the conservative approach often favored for these patients should be revised.. Almost 50 years after the first repair of an ASD was performed,11 controversy still exists as to whether adult patients, especially if they are asymptomatic or mildly symptomatic, benefit from surgery. This is attributable in part to the absence of updated medical literature on the natural history of unoperated patients and the retrospective and unrandomized nature of the surgical series dealing predominantly with symptomatic patients.. As early as 1970, Campbell2 observed how increasingly difficult it was to determine the natural history of ASD because of the growing number of patients having surgery in infancy. Using necropsy ...
Trisha Menke seeks a treatment plan for her customers that helps improve their quality of life as well as their duration of life in a realistic manner. She has special interests in cardiology, left atrial occluder device, atrial fibrillation/atrial flutter, primary cardiology prevention and heart failure. ...
UPDATE: This procedure is now called Venefit. The VNUS Closure FAST is a relatively new procedure designed to treat varicose veins. Unlike the olden days, when varicose veins were stripped surgically, the Closure procedure utilizes radiofrequency waves generated by an electrode to close the vein. The principles of the VNUS Closure Fast technique is to generate radiofrequency waves through an electrode. The heat generated from these electrode causes the veins to heat and eventually collapse. With time, the veins are removed by the body’s scavenging system.
CHARLEVOIX - Dr. Marc Lame will host an upcoming varicose vein screening to raise awareness for venous disease and available treatment options, including the VNUS Closure procedure.The free
Hi! Im 24 years old. My heart got fixed 3 years ago. ASD open heart surgery. After that I was living a extra carefull lifestyle. But laat month October 17 2016. Ive experienced a palpitation near in my...
The invention relates to a hemostatic plug having its own vessel wall locating system. The hemostatic plug allows accurate positioning of itself within an access incision, e.g., to a blood vessel, so that it is adjacent to, but does not extend beyond the vessel wall into the vessel lumen.
CX ilegx Collaboration embraces Electronic Endovascular Education. -A completely percutaneous closure approach is feasible in most cases. -Hands-on training and learning at the CX Office-Based Vein Practice Course. ...
BIOSTAR announces the debut their G300 series of solid-state drives (SSD). With the current trend of enthusiasts switching to SSDs for faster storage performance. With SSDs, games and level load faste...
XIANYANG, China, May 23, 2016 /PRNewswire/ -- Biostar Pharmaceuticals, Inc. Announces Its Quarterly Results for Three Months Ended March 31, 2016.
XIANYANG, China, Aug. 13, 2012 /PRNewswire-Asia/ -- Biostar Pharmaceuticals To Announce 2012 Second Quarter Financial Results On Tuesday, August 14th And...
the option will only use the samples defined with `-s`. You could have only one bam with 1000 samples. `-s S1,S2` would use only the samp ...
If this is taking too long, you can run it on a subsample (e.g. hundreds of samples) to identify parameters for the VST, and then apply it ...
I think at that time, I want to filter out some broad peak from the result, that why I set up `--broad-cutoff`. It depends on what you want ...