Boston scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Furthermore, an mr conditional monitoring system typically requires use only with ecg electrodes specifically designed. Hemashield finesse ultrathin, knitted cardiovascular patch vascular graft polyester boston scientific, strength 3. Oct 28, 2015 a number of studies have suggested a lower risk of postoperative restenosis with the use of both patch angioplasty and primary closure during ceas 39, although other studies have shown that the occurrence of restenosis may be independent of primary or patch closure.
The resultant ventriculoaortic incision was augmented with a single hemashield patch after mechanical valve insertion. Jul 06, 2018 gmdn preferred term name gmdn definition. Dacron sleeve around ascending aorta without excising the. Hemashield gold knitted microvel double velour getinge group. Transdermal patches are selfcontained discrete dosage forms that deliver drugs through the skin to the systemic circulation. Replacement of ascending aorta with 22 mm hemashield graft.
The epic valves are available in the aortic and mitral sizes indicated in table 1. The hemashield patch is the most used fabric for carotid. Recognized for exceptional performance and quality, they have earned the endorsement of renowned surgeons worldwide. Changes to manuals that are designated as safety were made to address safety issues. With the growing number of patients treated with permanent implanted or temporary cardiovascular devices, it is becoming ever more important to clarify safety issues in regard to the performance of mr examinations in patients with these devices. Improve patient care with topquality products from mri transport equipment to positioners, immobilizers, straps, and more. Patch angioplasty is commonly performed after carotid endarterectomy. Safety topic subject hemashield gold microvel knitted double velour vascular graft polyester. Provisions hemashield platinum woven double velour taaa graft configuration classification name. Indications for use photofix is indicated for the following uses. The hemashield patch is the most used fabric for carotid endarterectomy, providing reliable and safe performance. Similar disagreement also surrounds the use of temporary shunts in ceas. This site is not intended as a substitute for professional medical care. Describe the missile effect as it relates to magnetic force.
Whether the procedure requires a straight, one branch or. Gore vascular grafts are also available in a wide range of stretch, and nonstretch configurations, including straight, tapered, bifurcated, and many with external customizable ring reinforcement. Whether the procedure requires a straight, one branch or multibranch graft, hemashield. The most used fabric for carotid endarterectomy, providing reliable and safe performance. Randomized prospective trials and metaanalyses have documented improved rates of perioperative and longterm stroke prevention as well as reduced rates of restenosis for patches compared to primary closure of the arteriotomy. The level of detail we can see is extraordinary compared with any other imaging modality. Accessgudid hemagard carotid patch 00384401015208 hemagard carotid patch knitted ultrathin collagen coated vascular patch.
Mri information for healthcare professionals for specific information about a boston scientific products mr safety status, please refer to the products instructions for use or contact boston scientific customer service. Repaired ascending aortic aneurysm with hemashield platinum dacron graft. Maquet hemagard bifurcated vascular graft 22 x 11mm incorporate a highly filamentous, texturized low twist yarn into a stable, reverse locknit construction with excellent handling and suturing characteristics. Hemashield platinum grafts the most used, most studied vascular grafts. Nonclinical testing has demonstrated that the valiant thoracic stent graft is mr conditional. In 2 patients with a doubleoutlet right ventricle and a subaortic or noncommitted ventricular septal defect, a biventricular repair with intraventricular rerouting of the left. Selective patch angioplasty and intraoperative shunting in carotid endarterectomy. Pairing investments in clinical research and medical education with an expanding portfolio of vascular therapies, boston scientific is helping to deliver differentiated solutions to meet the needs of more patients worldwide. Maquet, 019579p, maquet hemashield platinum finesse.
Aortic aneurysm replacement with dacron graft in a 34 year. Hemashield platinum woven double velour vascular grafts from. A dacron sleeve around the dilated ascending aorta is a simple technique that allows the ascending aorta to adopt the shape of the dacron tube graft which avoids wrinkle formation, dislocation and. Special 510k device modification sep 1 2 2005 hemashield platinum woven double velour vascular graftsthoracoabdominal taaa graft configuration august 22, 2005 summary of safety and effectiveness general trade name. Provides an initial bloodtight seal, improved tissue ingrowth and excellent biocompatibility. Reimplant of innominate and left carotid artery with a 14 mm bifurcating hemashield graft and a right axillary artery cannulation and repair with retrograde cerebral perfusion and selective antegrade cerebral perfusion via the hemashield graft with hypothermic circulatory arrest. Selective patch angioplasty and intraoperative shunting in. Hemashield thoracic range woven straight and branch. Hemashield platinum finesse knitted cardiovascular patch. Patch, pledget and intracardiac, petp, ptfe, polypropylene product code dsy. Safety of magnetic resonance imaging in patients with. In addition to straight and bifurcated options, the following products with presewn. Cardiovascular patch, animalderived a sterile implantable material designed to reinforce suture lines andor increase the strength of weak or injured cardiac andor peripheral vascular tissues during cardiovascular repairreconstruction procedures e.
Mr safety selfstudy baptist health south florida 2012 3 course objectives 1. Refer to the mri safety information section of this manual for further information. Mri conditional claim for 3m radiolucent snap style electrodes. Hemashield platinum woven double velour vascular grafts. Safety of magnetic resonance imaging one to three days after bare metal and drugeluting stent implantation. Mri safe topixal patches sarasota anesthesiologists, p. Sep 1 2 2005 hemashield platinum woven double velour vascular graftsthoracoabdominal taaa graft configuration august 22, 2005 summary of safety and effectiveness general trade name. Controversy surrounds the selection of the patch material, with. The technology key benefits indications for useclinical story how to order feel the difference photooxidation vs. Magnetic resonance imaging mri is an important tool for diagnosing and evaluating diseases. Only your physician can diagnose and appropriately treat your symptoms. Hemashield platinum finesse ultrathin knitted cardiovascular patch sealed to a higher standard. This oxygen cylinder got too close to the mri unit.
Hemashield platinum finesse surgical fabrics, meshes. The hemashield woven double velour vascular graft is not approved for use as a coronary artery replacement. A unique case of an abdominal aortic aneurysm replacement in a young man of caribbean descent is presented. Indications, safety, and warnings aortic aneurysm repair. Using the current terminology, mr safe items include nonconducting, nonmetallic, nonmagnetic items such as a plastic petri dish. Since 1986, over 84,000 cryolife cryovein and cryoartery cryopreserved human vascular allografts have been implanted to treat a variety of vascular reconstructions such as peripheral bypass, hemodialysis access, and aortic infections which have saved the lives and limbs of patients. Gore propaten vascular graft, a leading prosthetic vascular graft for lower extremity revascularization, is specifically designed to reduce the risk of acute graft thrombotic failure. Therefore, the safety of using this ecg electrode attached to an ecg lead andor mr conditional monitoring system is unknown. By continuing to browse you confirm that you are a nonus resident requesting access. The hemashield grafts are the most used, most studied vascular products available in the market today. Labeling does not contain mri safety information device required to be labeled as containing natural rubber latex or dry natural rubber 21 cfr 801.
Graft, vascular, synthetic biologic composite name of. Behaviour of polyester grafts in adult patients with repaired. Behaviour of polyester grafts in adult patients with. The endurant ii aortouniiliac aui stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose. For additional information regarding mri please refer to the product instructions for use. Now tell me sir the fledgling program end your near and dear. Hemashield platinum woven double velour grafts are collagenimpregnated and come in straight, onebranch, or multibranch graft configurations for aortic repair. Hemashield platinum finesse surgical fabrics, meshes, and. Most dacron grafts are in the shape of a tube to replace or repair blood vessels. The page or information you have requested is intended for an audience outside the united states. Maquet hemagard bifurcated vascular graft, 22 x 11mm part. Pdf behaviour of polyester grafts in adult patients with.
Mri conditional claim for 3m radiolucent snap style electrodes 2244, 2570, 2660 and 2670. The safety and effectiveness of this product in the extraanatomic, av access and pulmonary positions, and as a patch, have not been established. Maquet hemagard bifurcated vascular graft 22 x 11mm has demonstrated longterm durability and resistance to postoperative dilation proprietary knit design produces outstanding handling and suturability low profile velour construction designed to promote optimal healing proven clinical safety and efficacy. Hemashield graft mri safety fruit japanese u12 t back pollinate many the fledgling program end.
Hemashield gold knitted double velour vascular grafts from. Magnetic resonance imaging mri equipment and supplies for use throughout the mri suite to help facilitate mri use. Patches of different types for carotid patch angiopla. An office chair was in the wrong place at any time. Epic standard valves are designed to allow intraannular placement of the inflow edge of the valve with supraannular placement of the sewing cuff. The hemashield platinum finesse patch promotes exceptional handling, hemostasis and healing during vascular or cardiac patching procedures. Safety topic subject miscellaneous implants and devices. Glutaraldehyde fixation watch a short animated video to learn more about the photooxidation process, and how it is different from glutaraldehyde fixation. Mri information for healthcare professionals boston. The endurant ii bifurcated stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. Patch angioplasty is performed to prevent recurrent stenosis after carotid endarterectomy cea. Clinical safety of magnetic resonance imaging early after coronary artery stent placement. The initial working diagnosis was of a mycotic aneurysm, which has recently shown resurgence with intravenous drug abuse.
These grafts require no preclotting, resist dilatation and the spread of infection, and assure utmost thrombectomy safety. Our mri safe products help maximize safety and comfortfor both patients and medical staff. Over 20 years of experience over 2 million hemashield implants water permeability. Class 2 device recall hemashield finesse ultrathin knitted. Hemashield gold knitted double velour vascular grafts are collagenimpregnated and come in straight, bifurcated, or axillobifemoral options of varying lengths. Hemashield implantation in young patients with congenital. Postoperative cta showed no stenosis along the arteriotomy and mri showed no acute stroke.
Mri information for healthcare professionals boston scientific. Transdermal patches that must be removed before mri. Hemashield finesse ultrathin knitted cardiovascular patch indicated for cardiac and vascular patch grafting. Terminology from the american society for testing and materials astm international and utilized by the food and drug administration refers to mr safe as an item that poses no known hazards in all mri environments. Clinical research congenital heart disease behaviour of polyester grafts in adult patients with repaired coarctation of the aorta els troost1, marc gewillig2, willem daenen3, bart meyns3, jan.
Mri provides an unparalleled view inside the human body. View all previous versions to request a previous version, contact customer service. Maquet cardiovascular, llc products and mri compatibility. This results in longterm stability and resistance to dilatation. Repaired ascending aortic aneurysm with hemashield. A dacron graft can be used as a stent to repair an artery, blood vessel, or other hollow structure in your body such as the tube that carries urine to. The patient was treated with aspirin and has had no further episodes.
Pdf rupture of equine pericardial aorticroot patch after aortic. Advisa dr mri surescan pacing system advisa dr mri surescan a2dr01 digital dual chamber pacemaker and surescan leads more. Advisa dr mri surescan pacing system advisa dr mri surescan a2dr01 digital dual chamber pacemaker and surescan leads. A dacron sleeve around the dilated ascending aorta is a simple technique that allows the ascending aorta to adopt the shape of the dacron tube graft which avoids wrinkle formation, dislocation and erosion. A dacron graft can be used as a stent to repair an artery, blood vessel, or other hollow structure in your body such as the tube that carries urine to hold it open. Uracs accreditation program is an independent audit to verify that a. Advances in magnetic resonance mr imaging over the past 2 decades have led to mr becoming an increasingly attractive imaging modality. With more than 30 years of bovine tissue expertise and the proven performance of tissue processed through edwards proprietary xenologix technology for surgical heart valves, the edwards bovine pericardial patch is a dependable solution for cardiac and vascular procedures. Epic standard valves are designed to allow intraannular placement of the inflow edge.
With more than a decade of strong performance that includes improving outcomes and reducing reinterventions, this longstanding bypass graft helps deliver both proven clinical and economic value for patients. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery. Mri safety training programs for levels 1 and 2 mr personnel, what to expect during your mri, projectilemissile effect videos, and superconducting magnet quenching shown from both inside and outside the mr system room. Hemashield platinum finesse knitted cardiovascular patch maquet. Right common carotid endarterectomy, internal carotid endarterectomy, external carotid endarterectomy, and hemashield patch angioplasty of the right common, internal. In 2 patients with a doubleoutlet right ventricle and a subaortic or noncommitted ventricular septal defect, a biventricular repair with intraventricular rerouting of the left ventricular out. Mri and patches it is highly recommended that any patient wearing a transdermal patch that has a metallic component be identified prior to undergoing mri. Hemashield thoracic range woven straight and branch grafts. Edwards lifesciences, the longestablished bovine tissue technology leader, introduces the duravess bovine pericardial vascular patch designed for dependable vessel repair. Patches of different types for carotid patch angioplasty rerkasem k, rothwell pm. Safety topic subject hemashield gold microvel knitted double velour vascular graft polyester boston scientific. Behaviour of polyester grafts in adult patients with repaired coarctation of the aorta. Identify safety risks in the magnetic resonance mr area.
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