Cordis Precise Stent, Please contact your Cordis A legacy that

Cordis Precise Stent, Please contact your Cordis A legacy that inspires the Future. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW). The Cordis PRECISE PRO RX® Nitinol Stent System used in conjunction with the ANGIOGUARD® RX Emboli Capture Guidewire is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. M. die Abtrennung der Verbindung zwischen zwei Sektionen der äußeren Katheterhülle meldeten. When the item is expired must be used for educational, training, veterinary or non-clinical research purposes only. Specifically, the Instruction for Use (IFU) for the impacted products state that the products are “MRI safe”. The PRECISE PRO RX ® Carotid Stent System, an industry benchmark carotid stenting system, is increasingly used by physicians to perform carotid artery stenting as an option for patients at high risk for surgery. 5F or 6Fsheathed delivery systems. * Cordis offers a complete range of products with unsurpassed clinical evidence to become your partner for the non-invasive treatment of carotid artery stenosis gs, and precautions. The Precise Pro RX is approved to treat carotid artery disease in patients at high risk for adverse events from carotid endarterectomy. 035” over-the-wire system CORDIS PC0730RXC Precise Pro Rx Carotid Stent System: 7mm x 30mm x 135cm - Surgamed #5271919 SILK ROAD MEDICAL SR-0930-CS Enroute Transcarotid Stent System - Short Dated Surgical #5204398 Cordis has initiated a labeling correction for S. 0 Description The Cordis PRECISE Nitinol Stent System consists ot a nItmbi selt-espanding sleet preloadedl on a 5SF1(1. As part of the Cordis policy of continuous product development, we reserve the right to change product specifications withou prior notification. APPROVAL FOR THE CORDIS PRECISE NITINOL STENT SYSTEM (5. Carotid Stent Systems In collaboration with Medicare Hellas, we offer the Cordis PRECISE PRO RX® Carotid Stent System which is paired with the Cordis ANGIOGUARD® RX Emboli Capture Guidewire System. This site is published by Cordis which is solely responsible for the content. 0適應症 Cordis Precise PRO RX 鎳鈦支架系統系與Cordis ANGIOGUARD RX栓塞捕捉導引線系統併用,適用於治療必須接受頸動脈血管修復術,且頸動脈內膜切除術可能引發不良反應之高危險群病患(請參考原文說明第8. A sub-study of ROADSTER patients received the Cordis PRECISE stent, which ting, which involves an incision in your leg). MRI may be performed immediately following the implantation of the PRECISE PRO RX® Nitinol stent(s). Cordis PRECISE PRO Rx Nitinol Stent System PC0940RXC GUDID 20705032036525 CORDIS CORPORATION FDA. and PRECISE stents due to incorrect MRI information on the Instructions for use (IFU). Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, suggested procedure, warnings and precautions. The Cordis PRECISE PRO RXTM Carotid Stent, with its multi-segmented, auto-tapering design, offers one of the best combinations of conformability and wall apposition. * Product Description PRECISE PRO RX™ Stent is the carotid stenting system, used by physicians to perfo Premarket Approval (PMA) FDA Home Medical Devices Databases The PRECISE PRO RX™ Nitinol Peripheral Stent System is a highly effective option for Carotid Artery Stenting, providing exceptional conformability and wall apposition. For Healthcare Professionals Only. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. This stent system offers proven results in clinical trials and features a unique micromesh design with a multi-segmental construction. R. THE MOST IMPLANTED STENT With low stroke, death, and MI rates, PRECISE PRO RX® Carotid Stent and ANGIOGUARD® RX Emboli Capture Guidewire System offer similar results as Carotid Endartectomy (CEA). Class 2 Device Recall Cordis Precise Nitinol Stent System FDA Home Medical Devices Databases The Cordis Product Labeling Website is designed to conveniently provide access to technical information on our products. The safety and effectiveness of the Cordis PRECISE Nitinol Stent System, used in conjunction with the ANGIOGUARD XP Emboli Capture Guidewire in the treatment of de novo or restenotic obstructive carotid artery disease in these patients was evaluated. * Product Description PRECISE PRO RX Stent is the carotid stenting system, used by physicians to perform carotid artery stenting as an option for patients at high risk for surgery. The reimbursement environment is complicated, and Cordis understands you need resources to navigate it. Contacte diretamente o fabricante ou um revendedor para saber o preço de um produto, pedir um orçamento ou para conhecer os pontos de venda mais próximos de si. For healthcar A field safety notice has been issued to correct a labelling issue by Cordis for self-expanding stents under MRI, specifically for SMART and PRECISE. Before undergoing implantation of any stent, speak with your doctor if you plan to have any type of surgery that may require you to stop taking antiplatelet medications. T. ® CONTROL® Transhepatic Biliary Stent, 10mm in diameter, 40mm in length, on an 80cm stent delivery system with a biliary indication Clinical Indication (B = Biliary) Catheter Working Length (S = 80cm, M Global Preferences: To continue, select settings and agree to the Terms Of Use Medical Information Center If you would like additional Cordis product information or support, please contact our Medical Information Center. 327. Auf der Basis von Reklamationen hat Cordis eine erhöhte Frequenz von Anwenderberichten erhalten, die Probleme beim Absetzen des Stents bzw. Performance Cordis Carotid System Cordis PRECISE® PRO RX Nitinol Self-Expanding Stent The ANGIOGUARD RX Embolic Protection Device, with its Rapid Exchange System, has been designed and tested to work in combination with the Cordis PRECISE PRO RX® Stent to provide ease of use, as well as enhanced safety over stenting alone. The delivery systems consist mainly of an inner shaft and an outer sheath with PRECISE PRO RX Stent is a carotid stenting system utilized for patients who are at high risk for surgery. Cordis offers a complete range of products with unsurpassed clinical evidence to become your partner for the non-invasive treatment of carotid artery stenosis gs, and precautions. Our team works with payers, providers and other health care advocates to support value-based clinical and economic decision making to ensure appropriate access to Cordis products and procedures. From the first guidewire to the first drug-eluting stent, Cordis has been at the heart of cardiovascular innovation for nearly 70 years. lications from carotid endarterectomy surgery. The document states “Cordis became aware that the APPROVAL FOR THE CORDIS PRECISE NITINOL STENT SYSTEM (5. 7714 Cordis PC0640RXC Precise Pro Rx Carotid Stent 6mm x 40mm 5F 135cm (X) ***EXPIRED 2024-02-29*** All Items listed are on inventory. 0 FR SIZES, OVER-THE-WIRE CONFIGURATION). As part of its continuous product development policy, Cordis reserves the right to change product specifications without prior notification. * Cordis has initiated a labeling correction for S. Due to its low profile design and incorporation of the Cordis TRUMARK Technology, the stent can be easily and accurately placed with minimal stent shortening. The stent is cut from a solid nitinol tube into a fine mesh ("Z" configuration) design. 00 Model # PC0840RXC OEM Cordis Expiration Date 2025 Size 8mm x 40mm x 135cm Current Stock: 1 Product Codes S. Self-Expanding Stents PRECISE PRO RX Carotid Stent System S. Consulte todas as informações sobre o produto stent de artéria carótida PRECISE PRO RX™ da empresa Cordis. Important information: Prior to use, refer to the instruction for use supplied with this device for indications, contraindications, side effects, suggested procedure, warnings and precautions. Silk Road Medical (SRM) has entered into a license and supply agreement with Cordis, whereby SRM has modified the FDA-approved Cordis PRECISE® PRO Rx Nitinol Stent System (PRECISE) for transcarotid delivery when used in conjunction with the ENROUTETM Transcarotid Neuroprotection System (cleared on February 9, 2015 under 510(k) K143072). Device Description The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5. The PRECISE PRO RX™ Nitinol Peripheral Stent System is a highly effective option for Carotid Artery Stenting, providing exceptional conformability and wall apposition. report › GUDID › CORDIS CORPORATION › 20705032036525 Bare-metal carotid artery stent PRECISE PRO Rx Nitinol Carotid Stent System - 8mm x 40mm x 135cm Cordis $125. Your Patient Implant Card has detailed information regarding the safest MRI conditions to be used after implantation of the PRE The Cordis PRECISE PRO RX™ Carotid Stent, with its multisegmented, auto-tapering design, offers one of the best combinations of conformability and wall apposition for Carotid Artery Stenting. Today, Cordis drives transformation through internal development, Cordis-X partnerships, and strategic acquisitions—powered by a global footprint and deep operational The FDA has recom-mended that physicians who use the device undergo spe-cial training; interventional physicians who are appropri-ately trained and credentialed may perform the proce-dures. O stent carotídeo Cordis PRECISE PRO RX ™ Sistema de Stent Nitinol, com seu design multissegmentado, oferece uma das melhores combinações de conformabilidade e aposição de parede para implante de stent na artéria carótida. The PRECISE PRO RXTM Carotid Stent, coupled with the short landing zone of the ANGIOGUARDTM RX EPD, creates a combination that’s suitable for virtually any CAS procedure. 035 PTA Dilatation Catheter SABER . Device Interaction and MRI Information If you require a magnetic resonance imaging (MRI) you have a stent implant. CONTROL Vascular Stent System S. International shipping requires a quote. THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY (DEFINED IN THE IFU) WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1 Premarket Approval (PMA) FDA Home Medical Devices Databases The Cordis PRECISE PRO RX® Carotid Stent System, one of the most implanted carotid stent systems, has been demonstrated to deliver excellent outcomes as proven by an extensive body of clinical The Cordis PRECISE PRO RX Nitinol Stent System is a single-use device consisting of an endovascular stent and sheath delivery system, intended to deliver a self-expanding endovascular stent to the carotid artery(ies). 85 mm) or 6F eathed delivery system. ® CONTROL® Transhepatic Biliary Stent and PRECISE® RX Transhepatic Biliary Stent EXAMPLE C 10 040 R S B S. The S. A. Please contact your Cordis Cordis PRECISE® Nitinol Stent System ANGIOGUARDTM XP Emboli Capture Guidewire A Patient's Guide to-Disease in the Carotid Arteries This guidebook is provided as a courtesy from Cordis Corporation intended to help you learn more about carotid artery disease. ™ Flex Vascular Stent System is engineered a flexible self-expanding stent. 3. CONTROL® Vascular Stent System is designed for superficial femoral artery (SFA) and iliac lesions. Cordis PRECISE PRO RX® Nitinol Stent System INDICATIONS FOR USE The Cordis PRECISE PRO RX® Nitinol Stent System used in conjunction with the ANGIOGUARD® RX Emboli Capture Guidewire is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria Your questions are important to us, call our Customer Service at 800. Used to treat iliac, femoral, and proximal popliteal lesions. 014 PTA Dilatation Catheter SABERX . They also recommended approval with conditions for the Cordis Precise Stent (a Johnson & Johnson compa-ny, Miami, FL) and AngioGuard Embolic Protection System. Information on how to use this site as well as additional information are presented below. The deivermy system consists, mnainly of an inner shaft and an outer sheath with radiopaque markers, PRECISE PRO RX Stent is the industry carotid stenting system, used by physicians to perform Carotid Artery Stenting as an option for patients at high risk for surgery. Cordis Corporation (Warren, NJ) announces the US and European launch of its next-generation carotid stent system, the Precise Pro RX Carotid Stent System, to treat clogged neck arteries. 5 FR AND 6. 1b節),並須符合下列條件。 The Cordis PRECISE Nitinol Stent System used in conjunction with the ANGIOGUARDTM XP Emboli Capture Guidewire is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy (see Section 8. MRI radiographers and healthcare professionals in the UK have been asked to ‘read and understand the updated compatibility information’ and share with relevant people in their organisations. THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY (DEFINED IN THE IFU) WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1 The Cordis PRECISE PRO RX Nitinol Stent System is a single-use device consisting of an endovascular stent and sheath delivery system, intended to deliver a self-expanding endovascular stent to the carotid artery(ies). For healthcar Balloon Expandable Stents Pre-mounted Balloon Expandable Stents . This stent is a one piece laser cut, self-expanding nitinol stent, combining a unique micromesh design with a multisegmental design construction. S. The Cordis PRECISE Nitinol Stent System used in conjunction with the ANGIOGUARDTM XP Emboli Capture Guidewire is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy (see Section 8. 014 PTA Dilatation Catheter PRECISE PRO RXTM Carotid Stent System Catheter Inner Shaft Tip Support member DISTAL POD POD Wire Lumen Stainless Steel Laser-Cut Helical Shaft Cordis Corporation (Warren, NJ) announces the US and European launch of its next-generation carotid stent system, the Precise Pro RX Carotid Stent System, to treat clogged neck arteries. Vascular Stent System PTA Balloons SABER . Cordis PRECISE PRO RX® Nitinol Stent System INDICATIONS FOR USE The Cordis PRECISE PRO RX® Nitinol Stent System used in conjunction with the ANGIOGUARD® RX Emboli Capture Guidewire is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria THE MOST IMPLANTED STENT With low stroke, death, and MI rates, PRECISE PRO RX® Carotid Stent and ANGIOGUARD® RX Emboli Capture Guidewire System offer similar results as Carotid Endartectomy (CEA). One out of 52 patients in the sub-study experienced a minor. 2 of these instructions) who require carotid revascularization and meet the criteria outlined below. For your convenience, a glossary of medical terms is included at the end of this booklet. 2. The devices used in the SAPPHIRE trial were the Carotid Stenting System (Cordis PRECISETM Nitinol Stent and AngioGuardTM XP Embolic Protection System) These are the brand names of the two devices that are used in combination to perform the procedure. The Cordis PRECISE PRO RX™ Carotid Stent, with its multisegmented, auto-tapering design, offers one of the best combinations of conformability and wall apposition for Carotid Artery Stenting. ta2dq, p5pn7, ilelp, 6wjn, sl8tg, enfo, hhcm, sotbu, gmqcl, bkt4n6,