Products Detail. MagResource database has the most comprehensive and up-to-date … 146,425.00 1% off Uniform architecture for optimal coverage of bifurcation anatomy. 2. Device Identifier (DI) Information. The physical and mental integrity of the subjects participating in a clinical trial. The purpose of this study was to report our experience with two new-generation DES for the treatment of intracranial atherosclerotic disease.Patients and MethodsWe retrospectively reviewed all patients treated with Taxus Element™ or Resolute … A randomized controlled trial of a Three-year clinical outcome of biodegradable hybrid polymer Orsiro sirolimus-eluting stent and the durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent showed TLF occurred in 4.7% and 7.8% at 3 years in the O-SES and R-ZES groups, respectively (log-rank p = 0.227). to Resolute Onyx and SYNERGY stents. Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. RSINT35015UX Medtronic Stent RSINT35015UX MicroTrac 3.50X15RX For inquiries about hard-to-get medical imaging parts we can supply or locate tested quality spares in the most common brands in the industry as GE, Siemens, Toshiba, Philips, Kodak, Hitachi among many others, covering all the modalities of systems for medical imaging diagnostic. Request PDF | On Oct 1, 2016, Soumya Patra and others published GW27-e0656 Zotarolimus eluting Resolute Integrity versus Everolimus eluting … Adapted from John Ormiston, MD, CRT 2013. Drug-Eluting Stent System Even better deliverability for the outstanding Orsiro DES The next level of deliverability1. It is generally safe to undergo magnetic resonance imaging scans with stents in place, though a lot of this depends on when the stent was implanted and what, exactly, it is intended to do. Prior to undergoing an MRI scan, inform your doctor that you have a Promus PREMIER Stent. Cell area: 14.5 mm². All stents n = 15. The Resolute Integrity ® stent is a zotarolimus- eluting system with a new BioLinx™ polymer that allows a … They include information on new medical technologies and treatments, clinical studies, publications and, of course, medical devices. Resolute Integrity Zotarolimus-Eluting Coronary Stent Medtronic, Inc., www.Medtronic.com The Resolute® zotarolimus-eluting stent (R-ZES) is a new generation DES currently approved for use in Europe and awaiting approval in the USA. The Resolute Integrity DES builds on the success of the market-leading Integrity bare metal stent. 2011 sales: $253 million (estimated) Maker: Terumo. Overview; Revolutionary Stent Engineering; Superior Deliverability; Enhanced Procedural Confidence Testing performed on Ultimaster™ Tansei™ Stent System (3.0 x 38 mm) n=1, Resolute Onyx™ Stent System (3.0 x 38 mm) n=1, Orsiro™ Stent System (3.0 x 35mm) n=1, Xience Alpine™ Stent System (3.0 x 38 mm) n=1, Synergy™ Stent System (3.0x38mm) n=1. Patients experience a better quality of life 3. With its unique design, XIENCE Sierra™ Stent is proven to provide unparalleled patient outcomes during and far beyond the intervention. the implantation of a Promus PREMIER Stent (s). Endeavor Resolute uses a proprietary new biocompatible polymer called BioLinx™. Use of an Integrity Coronary Stent System requires advanced Is Resolute Integrity Stent drug eluting? Resolute Integrity Brand Name: Structural Material: Stent RSINT25018UX MicroTrac 2.50X18RX Device Name: 2.50 mm Nominal Stent Diameter 8 mm Nominal Stent Length: 3.50 mm Maximum Stent Diameter: Cobalt Alloy Parylene C, BioLinx Po Zotarolimus Coating: MRI Safe: Yes Stents are basically small tubes or sometimes springs that help prop arteries open. Overview. Catalog Number: … Overview; Most Deliverable DES; Powerful Clinical Performance Across the Patient Spectrum; The First and Only DES Indicated For Patients With Diabetes; Now Available in 34 and 38mm Lengths; Indications, Safety & Warnings; Integrity. Version or Model: RSINT27518UX. Based on bench testing. All stents 3.00 mm, n=3; Promus PREMIER Stent, Xience Xpedition Stent, Xience V Stent and Resolute Integrity Stent. 1 This in turn helps: Interventional cardiologists achieve enduring and positive patient outcomes 2. Maximum 15 min of scanning (per sequence). Medtronic is currently seeking CE mark clearance from the FDA for … The number of coronary stents may be over half a million world-wide. All current, commercially available coronary stents may be imaged at 1.5T or 3T at any time: Maximum whole-body-averaged specific absorption rate (SAR) of 2-W/kg in Normal Operating Mode. Powerful clinical evidence 2. The safety and effectiveness of the Resolute Integrity stent have not been established in the cerebral, carotid, or peripheral vasculature. Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. Resolute Integrity Zotarolimus-Eluting Coronary Stent . Stent: Nobori. Abstract. Resolute Integrity. Side branch expansion. "The BIO-RESORT trial demonstrates the continued value of high-quality randomized DES trials in true all-comers, reflecting real world clinical practice. 2 Prof. Clemens von Birgelen, Thoraxcentrum Twente, MST, Enschede, the … The Resolute Integrity Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤35 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.20 mm. From Medtronic . The MeKo electropolishing guarantees an exceptionally smooth stent surface. The XIENCE V® stent should not migrate in this MRI environment. - The manufacturer’s warranty applies to the system composed of the device and lead (by the same manufacturer). DUTCH PEERS was the first randomised trial to investigate the Resolute Integrity stent. MeKo‘s heat treatment produces the world‘s smallest grain sizes (ASTM11 for 316L/316LVM) for higher corrosion resistance and smoother surfaces after the stent dilatation. ... Resolute Integrity Coronary Stent Implant Card . However, if you need magnetic resonance imaging (MRI), the technician will need to operate the machine within certain limits. - The Medtronic Resolute Integrity Coronary Drug Eluting Stent's unique design provides superior deliverability and conformability - The drug eluting stent is highly l... Rs. Iii . However, if you need magnetic resonance imaging (MRI), the technician will need to operate the machine within certain limits. Copper phantom to simulate body mass. Implant Card . When dual anti-platelet therapy was stopped at one year, the TLR rate for Orsiro was 1.0%, compared with 3.7% for Resolute Integrity and 2.7% for Synergy. Bench test data on file at Boston Scientific. ZOTAROLIMUS-ELUTING CORONARY STENT SYSTI:M . This study evaluated the performance of the Resolute Integrity DES compared with the historical performance of Xience V. Methods and Results: We assessed the … The Resolute Integrity drug-eluting stent (DES) combines continuous sinusoid technology with two key elements of the original Resolute DES: the … Medtronic MRI Resource Library. From X-rays to sonograms to CT Scans and MRIs, Resolute Health Hospital’s imaging specialists are ready to assist you. The Endeavor stent was designed as a synthesis of the best available medical, material, pharmaceutical and manufacturing technology. (Orsiro 0.10 ± 0.35 mm, Resolute Integrity 0.16 ± 0.39 mm, p for non-inferiority <0.001). Accessdata.fda.gov DA: 22 PA: 33 MOZ Rank: 55. ; Best in Class Radial Strength: Easily withstands pressure of the carotid artery, ability to resist recoil and maintain a … We have reviewed and classified all the major stents currently available world … The Resolute Integrity ® stent is a zotarolimus- eluting system with a new BioLinx™ polymer that allows a … Our database lists over 18,000 implants & features daily updates. Endeavor Resolute uses a proprietary new biocompatible polymer called BioLinx™. 3. Based on bench testing. In the clinical trials analyzed to date, differences in the incidence of stent thrombosis have not been associated with Gradient coating ensures polymer integrity reducing risk of delamination, even when overexpanded3. Diagnostic Imaging. Brand Name: Resolute Integrity™. The device is … Months vs. 12 Months vs. 24 Months Dual Antiplatelet Therapy in Patients Treated With the Resolute Zotarolimus Eluting Stent: Insights from the RESOLUTE US Trial", looked first at patients in the RESOLUTE US Trial. In this 375 patient randomized trial with an angiographic primary endpoint of late lumen loss (LLL) at 9 months, Orsiro demonstrated non-inferiority to Resolute Integrity. The BioLinx polymer is designed to confer the same biocompatibility as the Endeavor stent’s phosphorylcholine (PC) polymer while extending the duration of … Patients achieve a better quality of life 3. LowElast optimizes the crimp-behavior of L605 stents. The R-ZES utilizes a novel biocompatible polymer on a cobalt–chromium ... A new Integrity® stent platform, engineered with a continuous sinusoid Resolute Integrity is the successor of the Resolute DES which was based on a Driver modular stent platform whilst Integrity is a continuous piece of wire with a sinusoidal shape wrapped into a cylinder. With the exception of the stent platform, the two stents have the same basic technical characteristics. Approved in the U.S. in 2017 following Resolute Integrity DES, the newest-generation Resolute Onyx is the first and only DES to feature Core Wire Technology, a unique Medtronic method of stent manufacturing that involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. The one year outcomes also found no statistically significant difference in stent thrombosis between Resolute Integrity and the BP-DES groups (difference of 0.1 percent; p=0.77). According to the MHRA (2014 section 4.11.2.4) each coronary stent needs to be identified to determine its MRI safety status, usually by reference to the manufacturer’s literature. Additional background information and discussion. The safety and effectiveness of the Resolute Integrity stent have not been established in the cerebral, carotid or peripheral vasculature. The Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity System) is a device/drug combination product comprised of the following device components: the Integrity Coronary Stent and MicroTrac delivery systems and a drug … Reveal LINQ Insertable Cardiac Monitoring (ICM) System. The non-obstructive lesion with cholesterol crystal (arrow) was medically managed. The neurologist and radiologist are frequently confronted with cardiac patients who have had a recent carotid or coronary stent implanted and present with an acute and unrelated stroke for which an MRI is recommended. The Orsiro cohort also showed a lower rate of definite or probable stent thrombosis, at 0.6%, than either Resolute Integrity or Synergy (both 1.5%). Endeavor Resolute® (ER) (Medtronic, MN, USA), the second ZES, had a biocompatible BioLinx polymer and extended delivery of zotarolimus with 85% of drug released within 60 days and the remainder by 180 days.2 More recently introduced ZESs include the Resolute Integrity® with greater deliverability and conformability and the Resolute Onyx® with … Focusing on patients with small vessels, three-year outcomes of the BIO-RESORT randomized controlled trial (RCT) showed a significantly lower target lesion revascularization (TLR) rate and thus better efficacy of the Orsiro ® drug-eluting stent 1 (DES) in comparison to the Resolute Integrity DES. Stent thrombosis is a low-frequency event that current drug-eluting stent (DES) clinical trials are not adequately powered to fully characterize. Bench test results may not necessarily be indicative of clinical performance. 2.50 mm stents; Promus PREMIER Stent n = 15, Xience Xpedition Stent n = 3, Resolute Integrity Stent n = 3. The Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity System) is a device/drug combination product comprised of the following device components: the Integrity Coronary Stent and MicroTrac delivery systems and a drug component (a formulation of zotarolimus in a polymer coating). Description. Proven safety … accessdata.fda.gov . RSINT40038W Medtronic Stent RSINT40038W MicroTrac 4.00X38OTW For inquiries about hard-to-get medical imaging parts we can supply or locate tested quality spares in the most common brands in the industry as GE, Siemens, Toshiba, Philips, Kodak, Hitachi among many others, covering all the modalities of systems for medical imaging diagnostic. High bleeding-risk patients on longer DAPT regimens are three times more likely to have bleeding events, the company said. This library contains technical information on whether an MRI scan can be performed and how to perform a scan on … The Resolute™ Integrity Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.20 mm. Heat treatments of NiTi for shape setting and Af-temperature … The Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity System) is a device/drug combination product comprised of … 145,041.75 Rs. 1 This in turn helps: Interventional cardiologists achieve enduring and positive patient outcomes 2. Insertable Cardiac Monitor. PurposeThin-strut, flexible DES are suitable for intracranial stenting and may improve long-term vessel patency. Open cell, 2-link design for easy side-branch access. Medtronic Reveal LINQ Model LNQ11. 3. Resolute Integrity consists of: cobaltbased alloy (MP35N) Integrity stent platform, a coat consisting of Parylene C primer and BioLinx polymer and zotarolimus. Resolute Integrity Zotarolimus-Eluting Coronary Stent . General MRI compatibility conditions. The Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System (Resolute Onyx™ system) consists of a balloon-expandable, intracoronary, drug-eluting stent (DES) premounted on … The Resolute Integrity ® stent is a zotarolimus-eluting system with a new BioLinx™ polymer that allows a slower drug elution. The Resolute™ zotarolimus-eluting stent (R-ZES; Resolute™ Integrity; Medtronic Inc., Santa Rosa, CA, USA) is a zotarolimus-eluting system with Integrity™ cobalt alloy stent platform that further enhances the flexibility and deliverability of the stent in complex lesions by incorporation of a continuous sinusoidal design and with a new BioLinx™ polymer that allows … Non-clinical testing has demonstrated that the Promus PREMIER Stent is MR Conditional for single and overlapped conditions up to 74 mm. 9 Compared with Ultimaster. In addition, the Resolute Integrity … Metallic objects placed in the body can pose problems for MRI scans, which use a strong magnetic field and pulses of radio waves to see inside the body. Static magnetic field of Tesla Spatial gradient field of Gauss/cm Maximum whole body averaged specific absorption rate (SAR) of W/kg for minutes of scanning. Testing performed on XIENCE Sierra Everolimus Eluting Coronary Stent System (3.0 x 18 mm) n=5, SYNERGY Stent System (3.0 x 20 mm) n=5, Resolute Onyx Stent System (3.0 x 18 mm) n=5. Resolute Integrity is the successor of the Resolute DES which was based on a Driver modular stent platform whilst Integrity is a continuous piece of wire with a sinusoidal shape wrapped into a cylinder. Stent thrombosis is frequently associated with myocardial infarction (MI) or death. Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated. Approval for labeling changes to update the MRI Conditional information in the Instructions ... 135 Review Tra RESOLUTE MICROTRAC/ RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM ... MRI is limited to the evaluation of the proximal coronary arteries but allows … The third-generation, permanent-polymer zotarolimus-eluting (Resolute Integrity) and everolimus-eluting (Promus Element) stents were similarly efficacious and safe, with excellent clinical outcomes in a real all-comer patient population. A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a … Resolute Health Hospital certified radiologists are an invaluable resource when imaging tests are required for accurate and timely diagnosis. Zotarolimus-eluting stent [dashed line: (3.5 × 18 mm Resolute Integrity ®, Medtronic, Minneapolis, MN, USA)] was successfully implanted at culprit lesion. Medtronic won FDA regulatory approval and is releasing in the U.S. its Resolute Onyx drug-eluting (zotarolimus) stent. sr.no stent description company cost to patient; 1: medtronic resolute integrity drug eluting stent: medtronics: rs.31584/-2: medtronic resolute drug eluting stent: medtronics: rs.31584/-3 GMDN Definition. The next level of deliverability1 1st in Push4 Transmitting up to 57% more force from hub to tip. The Resolute™ Integrity Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.20 mm. • The Integrity Coronary Stent Systems are provided sterile, for one procedure only. Drug eluting stents were designed to prevent the formation of scar tissue inside of the cardiac arteries which could be caused by bare-metal stents. 4, page 2 of 16 Kim et al: Endeavor Versus Resolute Integrity Zotarolimus-Eluting Stents within 2 days whereas in the case of B-polymer system, the zotarolimus release is more delayed (50% and 85% zotarolimus is released at 7 and 60 days), and occurs for over 180 days after percutaneous coronary The Cordis PRECISE PRO RX Stent offers: Excellent Contourability: Micromesh geometry and segmented design helps the stent conform to the artery wall; best in class wall apposition, autotapering design and excellent stent flexibility. Medtronic, Inc. Minneapolis, M. 3. The BioLinx polymer is designed to confer the same biocompatibility as the Endeavor stent’s phosphorylcholine (PC) polymer while extending the duration of … Do not resterilize. Xience V Stent n = 10: 0.11 N/mm. The purpose of this study was to report our experience with two new-generation DES for the treatment of intracranial atherosclerotic disease.Patients and MethodsWe retrospectively reviewed all patients treated with Taxus Element™ or Resolute Integrity™ stent for an intracranial atherosclerotic stenosis between March 2011 and August 2013. Commercial Distribution Status: In Commercial Distribution. MR unsafe – an item that is known to pose hazards in all MRI environments. Test method: Expand a cell with a balloon at nominal pressure. MagResource is a web-based, searchable online database of printable MRI safety information for medical implants. From Medtronic . 2. All stents 2.50 mm, n=1; Promus PREMIER Stent, Xience Xpedition Stent, Xience V Stent and Resolute Integrity Stent. Insertable Loop Recorder. The magnetic field could dislodge the object, while radio waves could make it heat up. The Resolute Integrity stent system has demonstrated noninferiority when compared with other stents and holds the promise to treat more complex coronary lesions. as per dpco & nppa guidelines, effective 1st april 2019, following are the prices of various coronary stent being charged to the patients. Evalyn Broderick Date: March 14, 2022 A medical professional reviewing an MRI.. Test performed by and data on file at Abbott. Date of coronary stent placement and device manufacturer should be documented prior to MRI. Product Description. all-comers trials compared to major modern drug-eluting stents (DES). Medtronic’s Resolute Onyx drug-eluting stent has earned the CE mark in Europe for a one-month dual-antiplatelet therapy (DAPT) for high bleeding-risk patients following coronary angioplasty. With its unique design, XIENCE Sierra™ Stent is proven to provide unparalleled patient outcomes during and far beyond the intervention. DIRECT II is a prospective, randomized study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to … Accessdata.fda.gov DA: 22 PA: 33 MOZ Rank: 55. The Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity System) is a device/drug combination product comprised of the following device components: the Integrity Coronary Stent and MicroTrac delivery systems and a drug … For the first time, patients can be scanned in weight-bearing positions in their precise location of the symptoms or pain. Is Resolute Integrity Stent drug eluting? 1st in Track4 ... Resolute Integrity (p = 0.009) Medtronic Resolute Integrity Drug-Eluting Stent Obtains FDA Approval for Treating Coronary Artery Disease. In two separate large randomized controlled trials, the Resolute DES matched the safety and effectiveness of Abbott Laboratories’ Xience V® DES, which represents the market-leading DES platform in the United States. 5. Use by the “Use by” date noted on the package. Upright MRI is the only "whole body MRI" with the ability to perform Positional Imaging™ which allows patients to be scanned in positions such as sitting or lying down. Art. MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of … Industry press releases form an inestimable resource for keeping up to date with the industry viewpoint on these latest developments in interventional cardiology. 4. A. Stents are metallic cages that hold open a coronary artery after angioplasty. Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. • Only physicians who have received appropriate training should perform implantation of the stent. Background: The Resolute Integrity coronary drug-eluting stent (DES), the next evolution of the Resolute DES, is designed with thinner stent struts and continuous sinusoidal technology to further enhance performance. If you need an MRI, ... Resolute Integrity . Consequently, today the Endeavor stent addresses a significant unmet need: offering the efficacy expected from a drug-eluting stent but with the safety profile more commonly associated with bare-metal stents. Resolute Integrity™ DES simplifies everyday challenges with: Optimized flexibility and conformability 1. Excellent structural strength 1. The drug-coating is intended to reduce inflammation at the site of the stent which could lead to tissue growth. In the first head-to-head randomised controlled trial of third generation durable-polymer drug-eluting stents for the treatment of coronary artery disease in an all-comers patient population, the Resolute Integrity drug-eluting stent (Medtronic) and the Promus Element drug-eluting stent (Boston Scientific) performed similarly on all measures except longitudinal … - Before every MRI, the device must be checked and correctly programmed. The third-generation cobalt-chromium-based zotarolimus-eluting Resolute Integrity stent uses a novel, open-cell stent design for increased flexibility and deliverability.13, 14 The stent platform is made from a single, sinusoidal-formed, helically wrapped, locally laser-fused wire (strut thickness 91 μm). MEDTRONIC. Description. MR unsafe items include magnetic items such as a pair of ferromagnetic scissors. As there are no known coronary stents … Resolute Integrity Stents and Platinum-Chromium Everolimus-Eluting . Nobori - The top drug-eluting stents. 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