Indications, safety, and warnings aortic aneurysm repair. The polyester grafts such as dacron are an excellent example of successful substitution of a synthetic material within the human body. The fda has received fewer than half a dozen reports of skin burns in patch wearers undergoing mri, sandra kweder, md, deputy director of the the fdas office of new drugs, said today at a news. Hemashield platinum finesse ultrathin knitted cardiovascular patch sealed to a higher standard. Ptfe felt pledgets buttress the space beneath sutures when there is a possibility of sutures tearing through tissue. Indications, safety, and warnings aortic aneurysm repair medtronic. Accessgudid duraguard dural repair patch 00085412531007 duraguard is prepared from bovine pericardium which is crosslinked with glutaraldehyde. Aortic aneurysm replacement with dacron graft in a 34 year. This press release contains forwardlooking statements. 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.
In 1985, dor introduced evcpp as a viable method for restoring a dilated left ventricle lv to its normal, elliptical geometry. 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. 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. Ptfe felt pledgets by cr bard medline industries, inc. The surgical techniques commonly used to treat an infected aortic pseudoaneurysm arising from the aortic cannulation site are a patch repair with allograft material, polyethylene terephthalate fiber dacron. Boston scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. The pericardium is procured from cattle originating in the united states. Particular attention is placed on the incidence, aetiology, investigation, presentation and management dilemmas. Safety topic subject hemashield gold microvel knitted double velour vascular graft polyester boston scientific, 3. It serves as the definitive resource for radiologists and other physicians, mri technologists, physicists, scientists, mri facility. Efficacy and safety of dacron patch in surgical treatment.
Hemashield finesse ultrathin knitted cardiovascular patch indicated for cardiac and vascular patch grafting. This results in longterm stability and resistance to dilatation. With the passage of time the body deposits its own tissue into the dacron graft. Mri safety information nonclinical testing has demonstrated that and epic heart valves are mr conditional. For additional information regarding mri please refer to the product instructions for use. Maquet hemagard bifurcated vascular graft, 22 x 11mm part. Greater target area and stronger magnet facilitates the location of the injection. Maximum spatial gradient field less than or equal to 3,000 gausscm.
Dacron patch aortoplasty repair of coarctation of the aorta carries an. Duraguard has been treated with 1 molar sodium hydroxide for. Hemashield platinum woven double velour vascular grafts. 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. In these investigations, ams products underwent evaluations for magnetic field interactions at 1. Advanced fluoropolymer technology enables our synthetic patch to seal around penetrating sutures and reduce suture line bleeding by as much as 88 percent. Augmenting the patients own pericardium to assist in closure following openheart surgery.
It has no harmful chemicals and is easy for our bodies to tolerate. Hemashield platinum woven double velour grafts are collagenimpregnated and come in straight, onebranch, or multibranch graft configurations for aortic repair. Mri since various studies have confirmed the safety of both in mri at 3 tesla. Nonclinical testing has demonstrated that the endurant ii stent graft is mr conditional. Therefore, this investigation evaluated mri safety at 3 t for septal repair implants cardioseal septal repair implant and starflex. Ideal for a variety of surgical suturing procedures, such as vascular closure, septal repair, myocardial closure and valvular suturing. Cardiac magnetic resonance imaging, ventricular septal rupture. A unique case of an abdominal aortic aneurysm replacement in a young man of caribbean descent is presented. When it is used in blood vessels, our bodies grow a new lining to the graft over time that is like our natural blood vessel linings. Complications possibly associated with its use include dehiscence wound separation at the surgical site, which can cause serious bleeding. Access our instructions for use and product manuals library. This oxygen cylinder got too close to the mri unit. Bifurcated dacron patch for simultaneous superficial.
A silicone elastomer dacron reinforced patch for suturingthe prosthesis in position is located at one end of the device shell. A 61yearold caucasian british man was referred to our unit with recent onset of severe left calf and thigh claudication and rest pain in his left foot. Dacron is so completely compatible with the body that rejection and calcification do not occur. Patch, pledget and intracardiac, petp, ptfe, polypropylene product code dsy. In peripheral vascular bypass surgery different synthetic materials are available for bypass grafting. The hemashield platinum finesse patch promotes exceptional handling, hemostasis and healing during vascular or cardiac patching procedures. It is also known as endoventricular circular patch plasty evcpp. Pericadial patch closure of asd secundum on nomothermic beating heart.
Mri information for healthcare professionals boston. A wide variety of dacron patch options are available to you, such as ecofriendly. Please consult instructions for use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. The duravess bovine pericardial vascular patch is intended for use as a surgical patch material for vascular reconstruction and repairs, peripheral vascular reconstruction and repairs, and sutureline buttressing. In seven patients, patch graft angioplasties were placed for recurrent stenosis of the carotid artery and in 29 patients a dacron patch graft was placed after carotid endarterectomy because of smallcaliber carotid ves sels. Nonclinical testing has demonstrated that the valiant thoracic stent graft is mr conditional. Most dacron grafts are in the shape of a tube to replace or repair blood vessels. You can also choose from embroidered, appliqued dacron patch there are 94 suppliers who sells dacron patch on, mainly located in asia.
To evaluate the efficacy and safety of a new domestic dacron patch in the surgical treatment of congenital heart disease chd with infective endocarditis ie, a clinical controlled trial is conducted. Magnetic resonance safety testing services mrsts is the worlds most experienced mrsafety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. A dacron graft is made out of a manmade synthetic polyester material. Dacron patch infection following carotid endarterectomy. Patent ductus arteriosus pda, atrial septal defect asd, ventricular septal defect vsd occluders, and patent foramen ovale. Coloplast had conducted a clinical study to evaluate the safety and effectiveness of a softsolid testicular prosthesis sstp.
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. An office chair was in the wrong place at any time. A dacron sleeve around the dilated ascending aorta is a simple technique that retains the smoothness of the internal surface of the dacron graft. Improvements to dacron grafts have reduced the risk of graft infection, but infections can still occur. The new domestic dacron patch has good clinical efficacy and safety. These encouraging results support the continued selective use of dacron patch graft angioplasty in carotid surgery. The dor procedure is a medical technique used as part of heart surgery and originally introduced by the french cardiac surgeon vincent dor b. Hemashield platinum finesse knitted cardiovascular patch maquet. Uracs accreditation program is an independent audit to verify that a. There was also a clinical suspicion of a connective tissue abnormality.
Advisa dr mri surescan pacing system advisa dr mri surescan a2dr01 digital dual chamber pacemaker and surescan leads more. Incidence of aneurysm formation after dacron patch aortoplasty. Efficacy and safety of dacron patch in surgical treatment of. Surgical wrapping of mild to moderate ascending aortic dilatation at the aortic valve is associated with early, reversed remodeling of the remaining proximal and distal aorta, without any shortterm. Duraguard is chemically sterilized using ethanol and propylene oxide. Class 2 device recall hemashield finesse ultrathin knitted. The initial working diagnosis was of a mycotic aneurysm, which has recently shown resurgence with intravenous drug abuse. Dacron sleeve around ascending aorta without excising the. Impact of cardiac magnet resonance imaging on management of. Mri safety aspects and artifacts of atrial septal defect and patent. Several magnetic resonance imaging mri studies have concluded that the ams products listed below will not produce additional risks to patients in association with mri procedures under the conditions used for testing. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery. Mri bioeffects, safety, and patient management is a comprehensive, authoritative textbook on the health and safety concerns of mri technology that contains contributions from more than forty internationally respected experts in the field. Mri safety aspects and artifacts of atrial septal defect and patent foramen ovale occluders at 1.
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