Contraindications This website is based in the U.S. and is subject to the laws and jurisdictions of the United States. 638B Band & 638R Ring. *Important Note: The Guidelines for the Management of Patients with Heart Valve Prostheses and Annuloplasty Rings Referred for MRI Procedures should only be implemented 3. Webheart valve prosthesis or annuloplasty ring has become available that substantially deviates from the above MRI conditions or that is labeled, MR Unsafe. }*n7?7U_B pZcur% yD!OTjPInQH/js9iN:}740t|d)9qK :w2K4Cn4/cnI4AN|}RRPKZJ{Uv WebSafety Topic / Subject DURAFORM Dural Graft Implant Depuy Synthes, www.depuysynthes.com Duran Annuloplasty Ring Model H601H, 35 mm, heart valve Medtronic Heart Valve Division Minneapolis, M. 1.5: Safe More Heart Valves and Annuloplasty Rings More Duran Ring Model 610R annuloplasty device Medtronic Heart Annuloplasty Ring and Band. Contact Technical Support. WebHealthcare Professionals CG Future Annuloplasty Ring and Band Surgical Valve Repair Indications, Safety, and Warnings Overview Flexible Anterior/Posterior support The CG Future ring and band provide enough stiffness to provide posterior remodeling, while preserving dynamic annular motion. raided polyester material resists stretching and B discourages crimping while enabling low resistance, smooth needle penetration along the entire width of ring or band.1,2 Annuloplasty Ring and Band. Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: Failure to comply with the conditions for use can cause damage to the implanted devices or serious injury to the patient, including death. Webprostheses and annuloplasty rings, including those that have unknown labeling information: (1) Patients with all commercially available heart valve prostheses and annuloplasty rings can be scanned at 1.5-Tesla/64-MHz or 3-T/128-MHz, regardless of the value of the spatial gradient magnetic field. Object Status. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis. Object Status. @W!@U57#CBrb'D,3xt B2} &D|$|Y+ 6D`.@^t A# 25)Sl4@\4HQKNGQ_flB7G|;D~S?.;fN#n Vj}[mN- The SimuPlus ring and band offer flexible solutions to mitral/tricuspid valve repair. WebSafety Topic / Subject CenterPointLock, Drainable Irrigator Sleeve Hollister Incorporated, www.hollister.com Annuloplasty ring Colvin-Galloway Future Band 638B annuloplasty device 638B Band & 638R Ring Medtronic, Inc. www.Medtronic.com. Conditional 5. Surgical Valve Repair. The associated risks for a patient with these devices. Safety Topic / Subject. 1/;L(Al]hK2BX)zAS]soe*K>k;tVIwe. %PDF-1.3 3. WebINDICATIONS, SAFETY, AND WARNINGS CG Future Annuloplasty Ring and Band Indications for Use This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: All conditions for use for all implanted devices. WebSimuForm Annuloplasty Ring for surgical valve repair The SimuForm ring is elevating mitral repair its flexible anterior part accommodates anterior motion, while the semi-rigid posterior part enables remodeling. Webheart valve prosthesis or annuloplasty ring has become available that substantially deviates from the above MRI conditions or that is labeled, MR Unsafe. Contraindications SimuPlus Annuloplasty Ring and Band - Surgical Heart Valves | Medtronic The associated risks for a patient with these devices. WebSafety Topic / Subject DURAFORM Dural Graft Implant Depuy Synthes, www.depuysynthes.com Duran Annuloplasty Ring Model H601H, 35 mm, heart valve Medtronic Heart Valve Division Minneapolis, M. 1.5: Safe More Heart Valves and Annuloplasty Rings More Duran Ring Model 610R annuloplasty device Medtronic Heart stream Webby Device Type. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling. Webannuloplasty device. Webannuloplasty device. WebHealthcare Professionals CG Future Annuloplasty Ring and Band Surgical Valve Repair Indications, Safety, and Warnings Overview Flexible Anterior/Posterior support The CG Future ring and band provide enough stiffness to provide posterior remodeling, while preserving dynamic annular motion. WebAnnuloplasty Ring and Band Surgical Valve Repair The CG Future is an annuloplasty system for mitral valve repair, designed to predictably remodel the annulus to maintain apposition of the anterior and posterior leaflets. WebINDICATIONS, SAFETY, AND WARNINGS CG Future Annuloplasty Ring and Band Indications for Use This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Please Enter the Model Number or Select the Valid Model Number From the List, Please Enter the Product Name or Select the Valid Product Name From the List. Safety Topic / Subject. WebINDICATIONS, SAFETY, AND WARNINGS Profile 3D Annuloplasty Ring Indications This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. For best results, use Adobe Reader to view Medtronic manuals. Medtronic, Inc. www.Medtronic.com. Download Product Information (opens new window) Indications, Safety, and Warnings Overview Flexible Anterior/Posterior Support Webprostheses and annuloplasty rings, including those that have unknown labeling information: (1) Patients with all commercially available heart valve prostheses and annuloplasty rings can be scanned at 1.5-Tesla/64-MHz or 3-T/128-MHz, regardless of the value of the spatial gradient magnetic field. Conditional 5. 4 0 obj WebDesigned for mitral and tricuspid valve repair, the Duran AnCore Annuloplasty System, available in both ring and band, offers: Better early postoperative LV systolic function over patients with a rigid ring 1; Allows annulus size and configuration to adapt to changes throughout cardiac cycle 2-4 Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis. Conditional 5. The SimuForm semi-rigid annuloplasty ring provides support for WebProstheses and Annuloplasty Rings Referred for MRI Examinations should only be implemented for use after the careful review by the supervising radiologist or other physician responsible for the MRI facility and with the adoption of the information as a written policy. Download Product Brochure (opens new window) Indications, Safety, and Warnings. NOTE: A patient may have more than one implanted device. SimuPlus Annuloplasty Ring and Band - Surgical Heart Valves | Medtronic WebINDICATIONS, SAFETY, AND WARNINGS CG Future Annuloplasty Ring and Band Indications for Use This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling. WebSafety Topic / Subject DURAFORM Dural Graft Implant Depuy Synthes, www.depuysynthes.com Duran Annuloplasty Ring Model H601H, 35 mm, heart valve Medtronic Heart Valve Division Minneapolis, M. 1.5: Safe More Heart Valves and Annuloplasty Rings More Duran Ring Model 610R annuloplasty device Medtronic Heart WebDesigned for mitral and tricuspid valve repair, the Duran AnCore Annuloplasty System, available in both ring and band, offers: Better early postoperative LV systolic function over patients with a rigid ring 1; Allows annulus size and configuration to adapt to changes throughout cardiac cycle 2-4 WebLearn more about the SimuPlus Annuloplasty ring and band by Medtronic. (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: All conditions for use for all implanted devices. D\Y6D1q x+cI-Bzb_FYb.X:aAP0[jIwZM(B-b The SimuPlus ring and band offer flexible solutions to mitral/tricuspid valve repair. Safety Topic / Subject. WebSimuForm Annuloplasty Ring for surgical valve repair The SimuForm ring is elevating mitral repair its flexible anterior part accommodates anterior motion, while the semi-rigid posterior part enables remodeling. WebINDICATIONS, SAFETY, AND WARNINGS Duran AnCore Annuloplasty System Indications This device is indicated for the reconstruction or remodeling of pathological mitral and tricuspid valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling. Webprostheses and annuloplasty rings, including those that have unknown labeling information: (1) Patients with all commercially available heart valve prostheses and annuloplasty rings can be scanned at 1.5-Tesla/64-MHz or 3-T/128-MHz, regardless of the value of the spatial gradient magnetic field. Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. WebHeart Valves and Annuloplasty Rings. The associated risks for a patient with these devices. Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera. Read our cookie policy to learn more including how you may change your settings. << /Length 5 0 R /Filter /FlateDecode >> WebHeart Valves and Annuloplasty Rings. The ring and band provide flexible support for physiological mitral and tricuspid valve repair. 1.5: WebSimuForm Annuloplasty Ring Indications: The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuPlus ring and band offer flexible solutions to mitral/tricuspid valve repair. 4!aa 2PV]wFNR*])0IJ]srV2 WebINDICATIONS, SAFETY, AND WARNINGS Profile 3D Annuloplasty Ring Indications This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling. 638B Band & 638R Ring. (\jtjNc}m_c=Th}l>uCzLU}>W_6]>hizcYkfIN3Y?Iy~hTFm*UPq22lsZFqhLDb(VKS3s`ACeuXz\is}WSR\oLC}[A>Y*=vnc;MT9(RE]}YTJWFU$ vDST'Up/U>"~ziBD_4sP#)=8@04G3cM I;ijNj('!}j=?Ez-> The ring and band provide flexible support for physiological mitral and tricuspid valve repair. 1.5: For access to the full library of product manuals, visit the Medtronic Manual Library. WebSimuForm Annuloplasty Ring Indications: The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. 0'7e?|xN_Jcb%`o"M_^e +fAi]BX]s&F ~@9"-~ cR-"m:+;V{izx|}q:]'""E>27{P;A7@}/A,Q}OQ,,wjx,~ii?PqZW21ZONr\:O+ZLq!(TeMHS}@,8bI1~'`_8PM *cO(VI6JzFNuSm>9UqR{c0vO(#+"B{%. Strength. Webby Device Type. Reports from device programmers include references to the model number: Product Name search includes brand or trademark names for many Medtronic products; however, not all products are included. WebSafety Topic / Subject Cosgrove-Edwards annuloplasty mitral and tricuspid band Model 4600 Edwards Lifesciences LLC www.edwards.com. ]@TE67)*-)SklG0%W)9ztJKCQ xu+; VkT8f+!xq/tfs! WebSimuPlusAnnuloplasty Ring and Band Surgical Valve Repair. Download product brochure (opens new window) Indications, Safety, and Warnings Overview Product details Clinical evidence raided polyester material resists stretching and B discourages crimping while enabling low resistance, smooth needle penetration along the entire width of ring or band.1,2 Download the latest version, at no charge. Download Product Information (opens new window) Indications, Safety, and Warnings Overview Flexible Anterior/Posterior Support @p~$> Object Status. 1.5,3: annuloplasty ring pyrolytic carbon, titanium heart Sulzer Medica and Sulzer Carbomedics. Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera. The patient's wallet card specifies the model number. Strength. WebINDICATIONS, SAFETY, AND WARNINGS Duran AnCore Annuloplasty System Indications This device is indicated for the reconstruction or remodeling of pathological mitral and tricuspid valves. Contraindications The SimuForm semi-rigid annuloplasty ring provides support for 1.5,3: annuloplasty ring pyrolytic carbon, titanium heart Sulzer Medica and Sulzer Carbomedics. WebSafety Topic / Subject CenterPointLock, Drainable Irrigator Sleeve Hollister Incorporated, www.hollister.com Annuloplasty ring Colvin-Galloway Future Band 638B annuloplasty device 638B Band & 638R Ring Medtronic, Inc. www.Medtronic.com. SimuPlus. WebSimuPlusAnnuloplasty Ring and Band Surgical Valve Repair. WebINDICATIONS, SAFETY, AND WARNINGS Duran AnCore Annuloplasty System Indications This device is indicated for the reconstruction or remodeling of pathological mitral and tricuspid valves. If the product name you seek is not listed, try looking for information by device type. Some cookies are strictly necessary to allow this site to function. 3: Conditional 5 WebLearn more about the SimuPlus Annuloplasty ring and band by Medtronic. Surgical Valve Repair. Contact Medtronic | Terms of Use | Privacy Statement | Medtronic Manual Library | Choose Region, (such as 9528, 3875-45, 305U219, ENSP30030W), (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim), (such as pacemaker, stent, otology implants, drug pump), All conditions for use for all implanted devices, The associated risks for a patient with these devices. WebSafety Topic / Subject Cosgrove-Edwards annuloplasty mitral and tricuspid band Model 4600 Edwards Lifesciences LLC www.edwards.com. SimuPlus. Healthcare professionals must research the conditions for use and instructions for each implanted device before proceeding with MRI procedures. *Important Note: The Guidelines for the Management of Patients with Heart Valve Prostheses and Annuloplasty Rings Referred for MRI Procedures should only be implemented Webannuloplasty device. WebDesigned for mitral and tricuspid valve repair, the Duran AnCore Annuloplasty System, available in both ring and band, offers: Better early postoperative LV systolic function over patients with a rigid ring 1; Allows annulus size and configuration to adapt to changes throughout cardiac cycle 2-4 Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis. 638B Band & 638R Ring. raided polyester material resists stretching and B discourages crimping while enabling low resistance, smooth needle penetration along the entire width of ring or band.1,2 Surgical Valve Repair. WebProstheses and Annuloplasty Rings Referred for MRI Examinations should only be implemented for use after the careful review by the supervising radiologist or other physician responsible for the MRI facility and with the adoption of the information as a written policy. *Important Note: The Guidelines for the Management of Patients with Heart Valve Prostheses and Annuloplasty Rings Referred for MRI Procedures should only be implemented Download Product Brochure (opens new window) Indications, Safety, and Warnings. WebAnnuloplasty Ring and Band Surgical Valve Repair The CG Future is an annuloplasty system for mitral valve repair, designed to predictably remodel the annulus to maintain apposition of the anterior and posterior leaflets.