ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. endstream endobj 306 0 obj <>stream With an updated browser, you will have a better Medtronic website experience. If this patient is implanted with an InterStim II Model 3058 Neurostimulator or an eligible serial number of an InterStim Model 3023 Neurostimulator (when implanted as a system including a neurostimulator, lead, and, extension as applicable), MRI examinations of the head only may be safely performed, - Maximum spatial gradient of 19 T/m (1900 gauss/cm), - RF transmit/receive head coil only (no RF transmit body coil), - Gradient slew rate limited to 200 T/m/s, - Normal operating mode (Scanning frequency of approximately 64 MHz only), - Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator, - Eligible Model 3023 Neurostimulators only: Disable the magnet switch, Scanning under different conditions may result in severe patient injury or device. 0000027823 00000 n In fact, many of them might be considering the InterStim in the near future. 0000028899 00000 n 0000009883 00000 n H\V7+KJ}Rs%0+JiRJ!sC[ySsLj5I/y]bqUG22&~[kWq4 @|K 0,.KKm[[E|B~\'[$NX!c3g{1-AbgQ`(3#DKp~y7GxR"X dq&+iUXN}YE2Q1G,Zr~8u"O{th8V*UQQZ [Ib"t/ hWy/__/~~r|?V%Kwp>#}TXXTP3gT9!yka X1'J$z"+vn~[i S+~nhaRUn+k]SY *%4rv),^-u`3t8qgtsm,).c3Dn #,3iP'[. 2009;137: 512-517.4United States Quick Facts. . 0000014402 00000 n You must demonstrate an appropriate response to the evaluation to be a candidate. Bolder actions. 0000009782 00000 n 0000023686 00000 n 0000006555 00000 n "; mso-font-charset:78; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1791491579 18 0 131231 0;} @font-face {font-family:"?? The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. startxref 0000011240 00000 n 0000006657 00000 n In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. With low energy settings, the device may last up to 15 years. endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. It is important to understand that ferromagnetic metals and metallic implants can be harmful if they move in the flight path of the MR scanner. 0000011736 00000 n This small device will improve patient satisfaction and reduce hospital readmissions. Save my name, email, and website in this browser for the next time I comment. Search by model name, product name, or device type. 0000010287 00000 n Br J Surg. 0000008245 00000 n Those lucky few will benefit from this devices latest enhancements. 0000018755 00000 n Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 0000016814 00000 n Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000018493 00000 n Update my browser now. He or she works closely with the MR medical director and MR safety officer. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. However, if the conditions for safe MRI are MRI of the hand can be safely carried out with the Medtronic Interstim II device. 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." Value in Health. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 0000013460 00000 n hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. Urol Clin North Am. &)k1}Ym@,C#k[q}[n 2009;15(9):728-740. Home ?? If you arent, you might as well find a urologist to help you out. 0000004372 00000 n 0000003937 00000 n It should be used after you have tried other treatments such as medications and behavioral therapy and they have not worked, or you could not tolerate them. Although many patients may benefit from the use of these treatments, results may vary. `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o We are Medtronic. igXOs!i']}E]Zxu#udHK}}{wMW~ia>=ekO zw,a_MfT\R "}con}l%BU?8>`MO{zcIRv2P,k{fXY0p0iX}Tk([orZjZEsh)v0:oHcg[_3/BX\>_7#-nLo.bpoUu~vwX"h 1Pc=r"5(K^4I@@G'AE*p N 0000006684 00000 n With an updated browser, you will have a better Medtronic website experience. . 0000004887 00000 n InterStim Therapy for Urinary Control (Medtronic, Inc., Minneapolis, MN), Neurostimulation System, Non-clinical testing has demonstrated that InterStim Therapy, systems have been found to be MR Conditional. <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> Sacral Neuromodulation Systems ' a9.aacz3CSoTz)_%v hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. The new Medtronic scanning parameters 1 increases SAR limits for 1.5 Tesla scans from 0.5 W/kg to 2.0 W/kg; and for 3 Tesla scans from 0.5 W/kg to 1.4 W/kg. Questions and Answers in MRI - MRI Questions & Answers; MR imaging . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . 0000012014 00000 n m The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. 0000041486 00000 n Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. Please talk to your doctor to decide whether these therapies are right for you. This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. 0000009598 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 756 129 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. Unintended Stimulation MRI may cause unintended stimulation from the implant. 0000014184 00000 n Under certain conditions; see approved labeling for details. 301 0 obj <> endobj Patients with InterStim SureScan MRI leads only. Medtronic Bladder Control Therapy delivered by the NURO system treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. 0000000696 00000 n World J Urol. Important note: Each device ind. The latest InterStim is a small, discreet device, making it a safe option for many. 0000008397 00000 n 1.5T and 3T head coil MRI scans. DUBLIN, Feb. 22, 2022 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation of the InterStim portfolio's recharge-free device - and it is available immediately. Treatments & Therapies 0000006501 00000 n Current Medical Research and Opinion. p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 756 0 obj Less than NBV132955H ? Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. 0000013304 00000 n Update my browser now. MRI safety guidelines from Medtronic have expanded the range of scan parameters that clinicians can use to provide patients with a comprehensive, reliable, and safe MRI experience. 0000007197 00000 n You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. 0000006938 00000 n Methods. 0 The InterStim II Model 3058 Neurostimulator is not rechargeable. HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y 427 0 obj <> endobj 0000012800 00000 n Click OK to confirm you are a Healthcare Professional. [UeK[Xe;vmy65R$yFi ", "We're on a mission to expand access to proven nerve stimulation therapies through technology advancements like InterStim X, InterStim Micro, SureScan MRI technology and the smart programmer, by offering patients personalized therapy options and by reaching them through direct-to-consumer marketing," said Mira Sahney, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. These instructions do not apply to other implantable products, or other devices, products, or items. %%EOF The purpose of the MR safety expert is to minimize risk and optimize scan plans. REFERENCE