TIPS & TRICKS for optimal SILK placement
|
|
- Morris Barker
- 6 years ago
- Views:
Transcription
1 I. Antiplatelet Premedication: The correctly chosen premedication is essential. PLAVIX (minimum 600mg) should ideally be administered during eight days prior to procedure (75mg per day). However, a loading dose of 600mg of PLAVIX may be administered the day before the intervention (although this is not preferable). In conjunction with PLAVIX, Aspirin therapy should be administered at a rate of 100mg per day. These are general guidelines and should be adapted to the status of the patient. II. SILK size selection 1. Diameter SILK s conformability is enhanced if the stent is open to its maximum diameter due to the fact that this facilitates deployment. Consequently, the selected SILK diameter should be the smallest compatible with the artery. Refer to the compatibility interval indicated on the label : For vessel from to Example: SILK4,0x should be selected (SILK4,0 are suitable for arteries of diameter 3.5 to 4.25) Ø4.2mm Ø4.2mm NB: SILK4,5 is also compatible (suitable for vessels with diameter ), although obtaining optimal conformability is more difficult due to its greater diameter. If the diameter of the artery distal to the lesion is smaller than the proximal one (sometimes due to a compression effect of the aneurysm on the artery itself), the SILK should be selected using the smaller (distal) diameter, as explained above. Always ensure that the proximal diameter (the biggest) is no larger (it can be the same) than the diameter of the SILK when Fully Open (check the label). Example Ø4.0mm Ø3.5mm SILK3,5x should be selected Suitable for vessel with diameters from 3.0 to 3.75 Fully Open diameter : 4.0 Exception: If the difference in diameters is too significant, the selected SILK should have a Fully Open diameter equal to the proximal (greater) diameter. The distal part of the SILK will then probably be oversized and particular attention should be paid during its deployment (as the distal oversizing may affect conformability) Example Ø4.5mm Ø3.0mm SILK4,0x should be selected For vessel of 3.5 min & 4.25 max Fully Open diameter : 4.5mm Note: Para-opthalmic aneurysms are usually treated with SILK4,0x Aneurysms proximal to opthalmic artery are usually treated with SILK4,5x Page 1 / 8
2 2. Length SILK shortens considerably when deployed. The following approximate shortening should be considered: 1/2 1/2 SILK length inside delivery catheter= L KT Nominal Ø length L NOM = L KT /2 Fully open length L FO = L NOM /2 SILK should extend from both ends of the aneurysm neck: 1.5 times the artery diameter as a minimum. However, if possible, it is preferable to leave 10mm of SILK extending from both ends of the aneurysm. Placement in wide neck aneurysms will result in increased shortening of the SILK as the expansion will be greater in the unconstrained neck of aneurysm. This must be taken into account by selecting a SILK longer than the normal intracranial stent that would otherwise have been selected. 1.5xØ artery = minimum for safety 10 mm = recommended Ø4.5mm Ø3.0mm In this type of case, select: SILK4,0x25 or SILK4,0x30 Note The selected SILK is usually 5 to 10 mm longer than the LEO+ which could also be selected for the same case. Unique Indication for fusiform Aneurysm In the case of a fusiform aneurysm, the SILK will shorten considerably as it deploys to its maximum diameter through the major part of its length. Consequently, the SILK should be selected according to the Fully Open length that is marked on the label. Note: A simple rule can generally be applied to determine the SILK size: Length of the Fully Open SILK = length of fusiform aneurysm plus 5 to 10 mm Example: In this case, select: SILK4,5x40 Fully Open length = 22 (approx. 15+5) Never plan to lengthen a SILK during its implantation by exerting tension (even slightly) on the SILK through the fusiform part of the aneurysm, as it will lead to the SILK jumping into the aneurysm. Due to the precise nature of correct size selection, it is difficult to size the SILK prior to the angiography performed during the placement procedure. For this reason BALT has developed the STARTERSET concept, which provides a panel of SILK sizes along with the size selected prior to the procedure. Thanks to the STARTERSET, it is possible to select a different size SILK at the time of implantation to ensure a safe and effective placement. Contact your BALT distributor for more information on STARTERSET. Page 2 / 8
3 III. Procedure 1. Access Perfect control of push and pull movements as well as a perfect stability of the catheters is mandatory whilst deploying a SILK. Therefore, it is important to take the time to build a stable coaxial platform to ensure one-to-one control of the practitioner s manipulations. We strongly advise that: For access to the anterior circulation a long (80cm) 6F introducer should be positioned in the common carotid or in the proximal internal carotid. Balt IVA6F80 is ideal for this purpose, although Terumo s Destination is also suitable. The sheath should not be longer than 80 cm (in particular a 90cm sheath is not ideal), as it will unnecessarily protrude outside the patient and may prevent the other catheters from being placed distally enough to deliver the Silk. A Guide catheter is used to enable a very distal placement with high stability. Balt FARGO is designed for this purpose. The Penumbra Neuron is also suitable for this purpose. It should be noted that FARGO has a greater resistance to distal kinking and has a bigger internal diameter, thus making contrast injection (for Roadmapping) easier. Additionally, FARGO can be easily placed more distally, in the carotid siphon or up to the basilar artery providing optimal support and security during SILK deployment. Page 3 / 8
4 2. Device preparation A SILK set comprises: 1 Delivery catheter Vasco+21 1 Y-connector with a side-arm adaptor ANRYV 1 SILK prosthesis mounted on its pusher, all packaged in an introducing tube VASCO+21 micro-catheter is pre-shaped with a Multi-Purpose distal curve (MP: approx 45 angle). It is generally not useful to change the curve. In the packaging the distal curve is protected by a blister. Do not manipulate this blister. Incorrect opening or detachment can damage or kink the catheter s distal end which may result in SILK blockage and catheter impaction during placement). Avoiding handling the distal part of the VASCO+21, pull firmly on the proximal hub to remove it from the protective tube to release the catheter. Its distal pre-shaped tip will withdraw from the protective blister unobstructed. Do not flush the catheter before doing this. Protection blister (do not manipulate) Take the catheter out by pulling on the hub without manipulating the catheter s distal tip Catheter hub It is essential to fully flush of the delivery catheter VASCO+21 and to check that the valve of the Y-connector does not leak. If blood backflows inside the catheter and saturates the constrained SILK, the SILK may be glued by fibrin (even with Plavix, Aspirin and Heparin) and will not open once deployed outside the catheter. HINTS & TIPS: - Some users soak SILK with a small quantity of pure heparin before flushing the introducer with normal saline solution. The efficacy of this practice is not proven however, and is the interventionalist s decision. - Many Interventionalists administer an anti-spasm drug through the guide-catheter s flushing port (3mg of Nimodipin for 1 litre). Page 4 / 8
5 3. Navigation and passage of SILK VASCO+21 is preferably used with a.014 guide wire. The VASCO+21 should be placed very distal to the placement site (for example, do not hesitate to mount Vasco+21 in the MCA in the case of a paraopthalmic aneurysm) and pull the guide wire out. (Fig.1) Fig.1 Vasco+21 Once done, straighten VASCO+21 as much as possible in order to eliminate or lessen the curves. This will facilitate the SILK mounting and control during deployment. (Fig.2) FARGO Fig.2 Straightening the Vasco will bring the FARGO up Partially insert the SILK introducer into the Y-connector. Increase the pressure on the perfusion bag to a maximum. Allow the saline solution to run out of the proximal end of the introducer for 30 seconds minimum, pulling and pushing the pusher so that the SILK moves backwards and forwards over a maximum of 1 cm until any existing air bubbles in the SILK disappear. The distal end of the pusher must remain inside the introducer throughout this manipulation. Advance the introducer until it reaches full contact with the VASCO+21 hub (the contact should be complete, but do not exert high pressure) and tighten the Y-connector firmly to avoid any movement between the introducer and the hub. Note: the passage of the SILK produces considerable distraction forces between the hub and the introducer, and if the latter shifts this poses 3 risks: - SILK can deploy inside the VASCO+21 hub and the device is lost - SILK shifts on its delivery wire, which considerably increases friction inside the catheter and SILK can become jammed in the catheter. - SILK s distal end may be damaged which can result in the failure of the distal portion of the prothesis to expand during deployment. Continue advancing SILK to the distal tip of VASCO+21, checking for the absence any leakage of the perfusion fluid at the Y-connector. Until the SILK is detached, never torque the delivery wire (torquing will lead to delivery wire s failure and the SILK can be lost) Page 5 / 8
6 4. Deployment Push out 15 mm of the delivery wire (the distal radiopaque end). (Fig.3) Pull VASCO+21 creating a fix-point on the delivery wire (like with Neuroform and Enterprise) until SILK comes out and deploys to approximately 1 cm. (Fig.4). This manipulation ensures that SILK does not move distally which can result in the wire struts of the SILK damaging the vessel wall. Using this technique, SILK shortens during deployment and the distal part draws back thus avoiding any traumatic movement. If this technique is not utilised, it generally leads to a slight annulus spasm at SILK distal end, which could cause reduction of flow. It is also possible that the distal segment of the SILK fails to expand if this technique is not observed. 15mm Fig.3 SILK proximal marker Fig.4 Do not push the delivery wire forward while unsheathing 1cm of SILK by pulling on the Vasco Once the SILK is deployed by approximately 1 cm, position the distal tip simultaneously pulling on the catheter and on the delivery wire. (Fig.5) Fig.5 Fig.6 Continue deploying the SILK by pulling back on the catheter and compensate with delivery wire advancement. Check that the delivery wire is advancing freely in the distal vasculature. (Fig.6) The procedure should be carried out delicately: Excessive pushing or pulling can adversely affect deployment. If necessary you may gently manipulate or play with the catheter, by pushing it forwards and pulling it backwards until the SILK has opened correctly. The added stability afforded by the FARGO guide catheter and the IVA6F80 long introducer facilitates this action. It is worth training with a model DEMO SILK, which BALT representatives use for demonstration. Example of wrong deployment: In this case, too much compression on the system is not allowing the SILK to deploy correctly. The problem is solved by pulling on the whole system (catheter and wire) Page 6 / 8
7 SILK is detached when its proximal marker overpasses the distal marker of VASCO+21. Before SILK is detached, make sure that it is correctly deployed through its entire length and its artery wall apposition is complete. Fig.7 Vasco+ marker Once detached, the SILK proximal tip might be not fully deployed (particularly in a curve). The most effective technique is to push the proximal end with VASCO+21 and make it open. In plain terms this technique is referred to as a kick in the ass. (Fig.7bis) SILK proximal marker Pushing the SILK with the Vasco+ can improve its deployment and wall apposition Vasco Vasco Fig.7bis It is crucial to take time to move the VASCO+21 over the delivery wire inside the SILK in order to position it very distally (sometimes the delivery wire should be straightened, to prevent VASCO+21 bumping into the proximal end of the SILK). During this procedure the catheter will press against the inside wall of the SILK and improve its apposition to the artery wall. Next, remove the delivery wire and straighten VASCO+21 by applying slow and gentle traction: thus it will press against the opposite walls of the SILK and ensure a good apposition. This technique is known as the Internal Massage. (Fig.8) Fig.8 Before removing VASCO+21, perform all the necessary angiographic assessments. Whilst VASCO+21 remains in position inside the stent, it is still possible to: - place a second SILK (using the same VASCO+21), i.e. to do a Telescopic SILK. - place a remodelling balloon, using an exchange guidewire through VASCO+21 (ECLIPSE with STEEL12D300: wire.012 /300cm long). This extra step is very rarely required if all the steps described above are correctly executed. After thoroughly checking that every aspect of SILK deployment is satisfactory, the VASCO+21 can be removed. Carefully study the hemodynamic changes. A phenomenon has been observed in which arteries disappear due to an alteration of pressure balances with communicating arteries in which there is no thrombus, nor which have any associated clinical consequences. It may also be observed that the SILK appears to be filled in, although a simple passage of a micro-guidewire makes the artery refill, without any thrombotic phenomenon being observed. We are currently unable to explain these apparent filling defects. Page 7 / 8
8 IV. Post-procedure NOTE: The following information reflects current knowledge in April 2009 and should be adapted to each patient in accordance with their individual condition and to take into account any further knowledge. If no contraindications are present, low-dose heparin (500U/h) can be administrated to the patient for twentyfour hours. Post-medication: PLAVIX 75 mg/day and ASPIRIN 100mg/day. The current consensus is to administer PLAVIX for a minimum of 3 months, and for 6 months if communicating arteries stem from the aneurismal sac covered by SILK and to administer ASPIRIN for 1 year. It is important that full communication and understanding be established with the patient to ensure this regimen is adhered to; several complications have been observed due to a premature ceasing of this premedication by the patient. In the case of treatment for a giant aneurysm, it is commonly observed that the aneurysm s size increases during the thrombosis period following SILK placement, probably due to an inflammatory response. This phenomenon could be a cause of: - Headaches - worsening symptoms (particularly visual) - arterial stenosis due to the compression exerted by the mass effect of the aneurysm (in particular when the artery is constrained against a bone structure) The phenomena may persist over a period of 3 to 8 days, generally during the 2 weeks following the procedure, or following the discontinuation of post-medication with PLAVIX. Corticoids can be administered in order to limit the consequences of the inflammatory response. We hope that these Tips & Tricks will enable you to work with SILK in a safe and effective manner. However, we strongly recommend that the first five SILK cases are monitored by a proctor specialising in SILK. BALT has several proctors and is at your service to coordinate their attendance for supervising early SILK cases. Page 8 / 8
Single Pass MCA Revascularization with Trevo
Single Pass MCA Revascularization with Trevo By Concentric Medical ProVueTM Retriever Case Reported By Sascha Prothmann, MD Klinikum rechts der Isar, Munich, Germany Images contained herein courtesy of
More information1 Description. 2 Indications. 3 Warnings ASPIRATION CATHETER
Page 1 of 5 ASPIRATION CATHETER Carefully read all instructions prior to use, observe all warnings and precautions noted throughout these instructions. Failure to do so may result in complications. STERILE.
More informationUsefulness of Coil-assisted Technique in Treating Wide-neck Intracranial Aneurysms: Neck-bridge Procedure Using the Coil Mass as a Support
Journal of Neuroendovascular Therapy 2017; 11: 220 225 Online December 14, 2016 DOI: 10.5797/jnet.tn.2016-0081 Usefulness of Coil-assisted Technique in Treating Wide-neck Intracranial Aneurysms: Neck-bridge
More informationBifurcated system Proximal suprarenal stent Modular (aortic main body and two iliac legs) Full thickness woven polyester graft material Fully
Physician Training Bifurcated system Proximal suprarenal stent Modular (aortic main body and two iliac legs) Full thickness woven polyester graft material Fully supported by self-expanding z-stents H&L-B
More informationQuick Reference Guide
Quick Reference Guide Indications for Use The AFX Endovascular AAA System is indicated for endovascular treatment in patients with AAA. The devices are indicated for patients with suitable aneurysm morphology
More informationMAXIMIZE RADIAL SOLUTIONS TO PERIPHERAL CHALLENGES
MAXIMIZE RADIAL SOLUTIONS TO PERIPHERAL CHALLENGES PUSHING BOUNDARIES Terumo Interventional Systems is committed to your success with innovative procedural solutions and ongoing support for your most challenging
More informationNON-COMPLIANT PTCA RAPID EXCHANGE DILATATION CATHETER
Page 1 of 5 NON-COMPLIANT PTCA RAPID EXCHANGE DILATATION CATHETER STERILE. SINGLE USE ONLY. Sterilized with ethylene oxide gas. Non pyrogenic. Do not resterilize. Do not use opened or damaged packages.
More informationFigure 1: Revolution TM Peripheral Atherectomy System Diagram. Table 1: Revolution TM Peripheral Atherectomy System Specifications Minimum Burr
Instructions For Use All instructions should be read before use CAUTION Investigational Device. Limited by Federal (or United States) law to investigational use. DEVICE DESCRIPTION: The Revolution TM Peripheral
More informationIntroducing a New Treatment Method for Brain Aneurysms
Pipeline Embolization Device Introducing a New Treatment Method for Brain Aneurysms UNDERSTANDING ANEURYSMS What is a brain aneurysm? An aneurysm is an outpouching in an artery caused by weakness in the
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
M AY. 6. 2011 10:37 A M F D A - C D R H - O D E - P M O N O. 4147 P. 1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control
More informationAncillary Components with Z-Trak Introduction System
Ancillary Components with Z-Trak Introduction System Zenith Flex AAA Endovascular Graft Ancillary Components Converter Converters can be used to convert a bifurcated graft into an aortouniiliac graft if
More informationCLARIVEIN INFUSION CATHETER
CLARIVEIN INFUSION CATHETER General Product Description Overview The ClariVein Infusion Catheter (ClariVein -IC) is an infusion catheter system designed to introduce physician-specified medicaments into
More informationRECOMMENDED INSTRUCTIONS FOR USE
Rapid Exchange PTCA Dilatation Catheter RECOMMENDED INSTRUCTIONS FOR USE Available in diameters 1.25mm to 4.5mm and in lengths 09mm to 40mm Caution: This device should be used only by physicians trained
More information1 Comparison of Warfarin and Aspirin for Symptomatic Intracranial Arterial Stenosis. N Engl J Med 352;13, March 31, 2005
The risk of ischemic stroke in patients with Intracranial Atherosclerotic Disease (ICAD) ranges from 7 to 24%. 1,2 Developed specifically for the treatment of ICAD, the Wingspan Stent System and Gateway
More informationER REBOA Catheter. Instructions for Use
ER REBOA Catheter Instructions for Use Prytime Medical Devices, Inc. 229 N. Main Street Boerne, TX 78006, USA feedback@prytimemedical.com www.prytimemedical.com US 1 210 340 0116 U.S. and Foreign Patents
More informationNeuroform EZ Stent System
Neuroform EZ Stent System Directions for Use 2 Neuroform EZ Stent System 1 cm 1.9 cm 135 cm 185 cm ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. warning
More informationZenith Alpha T HORACIC ENDOVASCULAR GRAFT
Deployment Sequence Zenith Alpha T HORACIC ENDOVASCULAR GRAFT www.cookmedical.com AI-D21183-EN-F Preparation and flush Proximal and distal components Remove the yellow hubbed inner stylet from the dilator
More informationCook Medical. Zenith Flex AAA Endovascular Graft with Z-Trak Introduction System Physician Training
Cook Medical Zenith Flex AAA Endovascular Graft with Z-Trak Introduction System Physician Training Bifurcated system Proximal suprarenal stent Modular (aortic main body and two iliac legs) Full-thickness,
More informationNeuroform Microdelivery Stent System
Neuroform Microdelivery Stent System Patient Information Booklet TABLE OF CONTENTS What is the Purpose of This Booklet?...2 What is a Wide Neck, Intracranial Aneurysm?...2 What is the Treatment for Wide
More informationNit-Occlud. Coil System for PDA Closure IMPLANTATION POCKET GUIDE. Rx only CV / B. Braun Interventional Systems Inc.
Refer to the Nit-Occlud PDA Instructions for Use for relevant warnings, precautions, complications and contraindications. This device has been designed for single use only. Nit-Occlud Coil System for PDA
More informationAcute dissections of the descending thoracic aorta (Debakey
Endovascular Treatment of Acute Descending Thoracic Aortic Dissections Nimesh D. Desai, MD, PhD, and Joseph E. Bavaria, MD Acute dissections of the descending thoracic aorta (Debakey type III or Stanford
More informationPenumbra INTRACRANIAL ACCESS REDEFINED
Penumbra INTRACRANIAL ACCESS REDEFINED BENCHMARK Case Examples Stability & Compatibility Atraumatic Navigation Flow Diverter Delivery Pipeline BENCHMARK Stability Without Surpass Full distal shaft radiopacity
More informationRadux StandTall Instructions for Use Sheath Extender and Securement Clasp
Radux StandTall Instructions for Use Sheath Extender and Securement Clasp USA Caution Federal (USA) law restricts this device to sale by or on the order of a health care professional. Caution The Radux
More informationInstructions for Use Cordis PRECISE PRO Rx Nitinol Stent System
100000017144.3 100000017144.3 Instructions for Use Cordis PRECISE PRO Rx Nitinol Stent System Figure 1.065" (1.65 mm) OR.078" (1.98 mm) 16 4 13 10 11 15 8 3 14.062" (1.57 mm) OR.065" (1.65 mm).038" (0.97
More informationSystem.
System www.penumbrainc.com POD System Case Examples 45 cm of POD Packing Coil in 1.5 to 3 mm diameter dilating vessel Bronchial Artery Embolization Dr. Amit Kakkar and Dr. Aksim Rivera, Bronx, NY Inflow:
More informationBalloon in Balloon (BIB )
Balloon in Balloon (BIB ) Stent Placement Catheter INSTRUCTIONS FOR USE CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Read all instructions prior to use. Distributed
More informationCardiva Catalyst III INSTRUCTIONS FOR USE
Cardiva Catalyst III INSTRUCTIONS FOR USE IFU 2469 Rev. G CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician. For single use only GRAPHICAL SYMBOLS ON THE CARDIVA
More informationRuby Coil. Large Volume Detachable Coils
Ruby Coil Ruby Case Examples 38 mm Hepatic Artery Aneurysm Pulmonary AVM 2 Coils Dr. James Benenati Miami Cardiac and Vascular Institute, FL Y90 Embolization Type 2 Endoleak Dr. J Moskovitz Florida Hospital,
More informationMULTILAYER FLOW MODULATOR (MFM ) FOR PERIPHERAL ANEURYSMS TREATMENT (LOWER LIMBS, VISCERALS AND SUBCLAVIAN)
0459 MULTILAYER FLOW MODULATOR (MFM ) FOR PERIPHERAL ANEURYSMS TREATMENT (LOWER LIMBS, VISCERALS AND SUBCLAVIAN) WITH ITS ANGIOGRAPHIC CONTROL DELIVERY SYSTEM INSTRUCTIONS FOR USE (I.F.U.) English Français
More informationPTA Balloon Dilatation Catheter
PTA Balloon Dilatation Catheter 1/6(3211-0) February 2016 TIS-488-06272017 Catalogue number Serial number Lot number Use by Do not reuse Do not resterilize Do not use if package is damaged Consult instructions
More informationINSTRUCTIONS FOR USE FOR:
INSTRUCTIONS FOR USE FOR: en English cs Čeština da Dansk nl Nederlands fi Suomi fr Français de Deutsch el Ελληνικά hu Magyar it Italiano lt Lietuvių no Norsk pl Polski pt Português es Español sv Svenska
More informationZenith Renu AAA Converter Graft. Device Description Planning and Sizing Deployment Sequence Patient Follow-Up
Zenith Renu AAA Converter Graft Device Description Planning and Sizing Deployment Sequence Patient Follow-Up Device description: Device indications The Zenith Renu AAA Converter Graft with Z-Trak Introduction
More informationSolving the Dilemma of Ostial Stenting: A Case Series Illustrating the Flash Ostial System
Volume 1, Issue 1 Case Report Solving the Dilemma of Ostial Stenting: A Case Series Illustrating the Flash Ostial System Robert F. Riley * and Bill Lombardi University of Washington Medical Center, Division
More informationAzur CX 35 Peripheral Coil System (Detachable) Instructions for Use
Azur CX 35 Peripheral Coil System (Detachable) Instructions for Use DEVICE DESCRIPTION The Detachable Azur CX 35 Peripheral Coil System (Azur system) consists of a coil implant attached to a delivery system.
More informationAdvancing Lives and the Delivery of Health Care. The High-Flow Port Designed for Apheresis
Advancing Lives and the Delivery of Health Care The High-Flow Port Designed for Apheresis Optimized for Long Device Life Bench Tested up to 1,000 Accesses 1 Bard is proud to introduce the first and only
More informationSolitaire FR Revascularization Device
Solitaire FR Revascularization Device FEATURING PARAMETRIC DESIGN Restore. Retrieve. Revive. 5 Revolutionizing Mechanical Thrombectomy with Parametric Design Solitaire FR Device The Solitaire FR revascularization
More informationFuture Perspectives of Micromesh Stents Antonio Micari MD Director Cardiovascular Units GVM Care and Research (Palermo, Italy)
Future Perspectives of Micromesh Stents Antonio Micari MD Director Cardiovascular Units GVM Care and Research (Palermo, Italy) Potential conflicts of interest Antonio Micari MD I have the following potential
More information(12) Patent Application Publication (10) Pub. No.: US 2012/ A1
(19) United States US 2012O316632A1 (12) Patent Application Publication (10) Pub. No.: US 2012/0316632 A1 Gao (43) Pub. Date: Dec. 13, 2012 (54) RETRIEVABLE COVERED STENT FOR (52) U.S. Cl.... 623A1.2 BFURCATION
More informationThe evolution. AORFIX AAA Stent Graft now with the new AORFLEX Delivery System
The evolution of AORFIX AORFIX AAA Stent Graft now with the new AORFLEX Delivery System The confident choice for the right angles AORFIX the only AAA stent graft approved for all angulations from 0 90,
More informationAXS Catalyst Distal Access Catheter
AXS Catalyst Distal Access Catheter Directions for Use 2 AXS Catalyst Distal Access Catheter ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. warning Contents
More informationInstructions for Use Reprocessed LASSO Circular Mapping Diagnostic Electrophysiology (EP) Catheter
Instructions for Use Reprocessed LASSO Circular Mapping Diagnostic Electrophysiology (EP) Catheter Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. DEVICE DESCRIPTION
More informationAssurant Cobalt Iliac BALLOON EXPANDABLE STENT SYSTEM
Assurant Cobalt Iliac BALLOON EXPANDABLE STENT SYSTEM Innovating for life. CONFORMABILIT Y 6 F S H E AT H C O M PAT I B I L I T Y THE ASSURANT COBALT ILIAC STENT, WITH ITS UNIQUE COBALT CHROMIUM MODULAR
More informationPTCA Dilatation Catheter. Instructions for Use
PTCA Dilatation Catheter Instructions for Use Rx ONLY Caution: Federal law restricts this device to sale by or on the order of a physician STERILE. Sterilized with ethylene oxide gas Distributed by Medinol
More informationZenith Alpha T HORACIC ENDOVASCULAR GRAFT
Device description Zenith Alpha T HORACIC ENDOVASCULAR GRAFT www.cookmedical.com AI-D21181-EN-F Modular design The two-piece modular system allows the physician to customize a graft system to fit each
More informationAccess More Patients. Customize Each Seal.
Access More. Customize Each Seal. The Least Invasive Path Towards Proven Patency ULTRA LOW PROFILE TO EASE ADVANCEMENT The flexible, ultra-low 12F ID Ovation ix delivery system enables you to navigate
More informationCardiac Output Technique For Small Animals
Cardiac Output Technique For Small Introduction Cardiac output (CO) is a measure of the quantity of blood pumped by the heart each minute and is the product of stroke volume (ie. volume of blood ejected
More informationINSTRUCTIONS FOR USE
PERICARDIUM COVERED STENT (PCS) INSTRUCTIONS FOR USE STERILE - Ethylene Oxide Sterilized. For single use only. Do not re-sterilize. THE CLINICAL TECHNIQUES AND PROCEDURES DESCRIBED HERE DO NOT REPRESENT
More informationDirections For Use. All directions should be read before use
Directions For Use All directions should be read before use DEVICE DESCRIPTION: The CLEANER.XT Rotational Thrombectomy System is a percutaneous, 6Fr catheter based system (single piece construction) that
More informationPeripheral Intravascular Lithotripsy (IVL) Catheter Instructions for Use (IFU)
Peripheral Intravascular Lithotripsy (IVL) Catheter Instructions for Use (IFU) For use with the Shockwave Medical, Inc. IVL Generator and Connector Cable Indication for Use The Shockwave Medical IVL System
More informationInstructions for Use 1
Instructions for Use 1 Instructions for Use IMPORTANT! Please read before use. Description The Sniper is a dual lumen catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen
More informationUnderstanding aneurysms and flow diversion treatment
Surpass Streamline Flow Diverter See package insert for complete indications, contraindications, warnings and instructions for use. INTENDED USE / INDICATIONS FOR USE The Surpass Streamline Flow Diverter
More informationPTA Balloon Dilatation Catheter
PTA Balloon Dilatation Catheter March 2016 1/6(3214-0) Catalogue number Serial number Lot number Use by Do not reuse Do not resterilize Do not use if package is damaged Consult instructions for use Keep
More informationCombine the best of both worlds
S c i e n c e B a s e d E v o l u t i o n s l e a d t o R e v o l u t i o n a r y S o l u t i o n s PIONEER CoCr STENT ON DEB Combine the best of both worlds A next step in cardiovascular treatment should
More informationPipeline Embolization Device
Pipeline Embolization Device The power to redefine aneurysm treatment. REDEFINE The Pipeline device redefines treatment for large or giant wide-necked aneurysms by reconstructing the parent artery and
More informationPCI for Ostial Lesion
PCI for Ostial Lesion ii) LAD ostial Osamu Katoh,M.D. kyoto Katsura Hospital Cardiovascular Center PCI for a LAD ostial lesion is well-known to be associated with a high restenosis rate because of excessive
More informationDocument No. BMB/IFU/40 Rev No. & Date 00 & 15/11/2017 Issue No & Date 01 & 15/11/2017
Central Venous Catheter Device Description Multi-lumen catheters incorporate separate, non-communicating vascular access lumens within a single catheter body. Minipunctur Access Sets And Trays: Used for
More informationPTCA Dilatation Catheter. Instructions for Use
PTCA Dilatation Catheter Instructions for Use Rx ONLY Caution: Federal law restricts this device to sale by or on the order of a physician STERILE. Sterilized with ethylene oxide gas Distributed by Medinol
More informationProven Performance Through Innovative Design *
Proven Performance Through Innovative Design * Deliver Our Next Generation AV Covered Stent Results The COVERA Vascular Covered Stent builds upon proven technologies from the category leader in AV Access.
More informationWe Catch. What Others Miss
We Catch What Others Miss GORE Embolic Filter Diamond Frame Circumferential Filter Attachment eptfe Filter Media with 100-Micron Pores and Hydrophilic Heparin Coating Diamond Frame designed to enhance
More informationIndications for use. Contraindications within the United States
Indications for use Indications within the United States The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta, including: Isolated lesions
More informationIntroduction What Causes Peripheral Vascular Disease? How Do Doctors Treat Peripheral Vascular Disease?... 9
Patient Information Table of Contents Introduction... 3 What is Peripheral Vascular Disease?... 5 What Are Some of the Symptoms of Peripheral Vascular Disease?... 7 What Causes Peripheral Vascular Disease?...
More informationCOIL SYSTEM ORDERING INFORMATION
EMBOLIZATION SYSTEM RUBY COIL SYSTEM FRAME with Ruby Standard FILL with Ruby Soft Now with 3 & 40 mm sizes! SYSTEM ANCHOR with Now designed to embolize 3 4 mm vessels! PACK with Coil Now with WAVE Shape
More informationNew Stroke Interventions. Scott L. Zuckerman M.D. Vanderbilt Neurosurgery
New Stroke Interventions Scott L. Zuckerman M.D. Vanderbilt Neurosurgery Agenda Clot Retrieval Devices Merci Penumbra Stent Retrievers Solitaire Trevo New Technology Funnel ReCover MERCI Retriever (2004)
More informationIntroduction 3. What is Peripheral Vascular Disease? 5. What Are Some of the Symptoms of Peripheral Vascular Disease? 6
Patient Information Table of Contents Introduction 3 What is Peripheral Vascular Disease? 5 What Are Some of the Symptoms of Peripheral Vascular Disease? 6 What Causes Peripheral Vascular Disease? 7 How
More informationSURPASS FLOW DIVERTER
SURPASS FLOW DIVERTER SCENT TRIAL UPDATE Ajay K. Wakhloo, M.D., Ph.D., FAHA Department of Radiology, Neurology and Neurosurgery Division Neuroimaging and Intervention University of Massachusetts SVIN -
More informationNIRxcell CoCr Coronary Stent System
cordis.com/nirxcell NIRxcell CoCr Coronary Stent System Exceptional Outcomes by Design Exceptionally low TLR rate of 5.1 % at 9 months 1 Superior Deliverability and Crossability 2 Best-in-class Conformability
More informationMalperfusion Syndromes Type B Aortic Dissection with Malperfusion
Malperfusion Syndromes Type B Aortic Dissection with Malperfusion Jade S. Hiramoto, MD, MAS April 27, 2012 Associated with early mortality Occurs when there is end organ ischemia secondary to aortic branch
More informationRepair of Intracranial Vessel Perforation with Onyx-18 Using an Exovascular Retreating Catheter Technique
Repair of Intracranial Vessel Perforation with Onyx-18 Using an Exovascular Retreating Catheter Technique Michael Horowitz M.D. Pittsburgh, Pennsylvania Background Iatrogenic intraprocedural rupture rates
More informationMechanical Thrombectomy of Large Vessel Occlusions Using Stent Retriever Devices
Mechanical Thrombectomy of Large Vessel Occlusions Using Stent Retriever Devices Joey English MD, PhD Medical Director, Neurointerventional Services California Pacific Medical Center Hospitals, San Francisco,
More informationTHE THE MORE MORE NATURAL APPROACH TO OPTIMAL FIT
THE THE MORE MORE NATURAL APPROACH Natural Approach TO Optimal Fit TO OPTIMAL FIT Conformability without Compromise THE STANDARD IN Conformability AND Designed for flexibility and conformability in tortuous
More informationPhoenix Atherectomy System Product Overview /LB
Phoenix Atherectomy System Product Overview Phoenix Atherectomy System- The next generation of atherectomy The first hybrid atherectomy system available Combines the benefits of existing atherectomy systems
More informationCARILLON Mitral Contour System (XE2)
CARILLON Mitral Contour System (XE2) Instructions for Use 0 3 4 4 Manufacturer: Cardiac Dimensions, Inc. 5540 Lake Washington Blvd. NE Kirkland, WA 98033 United States of America EC Representative: MedPass
More informationCoronary angiography and PCI
Coronary arteries Coronary angiography and PCI Samo Granda, Franjo Naji Department of Cardiology Clinical department of internal medicine University clinical centre Maribor Coronary arteries Atherosclerosis
More informationASAHI Corsair INSTRUCTIONS FOR USE
ASAHI Corsair INSTRUCTIONS FOR USE SYMBOLS Legal manufacturer Do not use if package is damaged GC Minimum GC I.D. REF Catalogue number Caution, consult accompanying documents Maximum injection pressure
More informationIndications. The AngioVac cannula is intended for use as a venous drainage cannula and for the removal of fresh, soft thrombi or emboli
Indications Straight Cannula or Cannula with 20 O Angle 17F Working Channel The AngioVac cannula is intended for use as a venous drainage cannula and for the removal of fresh, soft thrombi or emboli Radiopaque
More informationTechnique Of Carotid Stenting Decision Making Analysis To Overcome Challenges
Technique Of Carotid Stenting Decision Making Analysis To Overcome Challenges Subbarao Myla MD FACC Hoag Memorial Hospital Presbyterian Newport Beach, CA USA Presenter Disclosure Information Name: Subbarao
More informationTalent Abdominal Stent Graft
Talent Abdominal with THE Xcelerant Hydro Delivery System Expanding the Indications for EVAR Treat More Patients Short Necks The Talent Abdominal is the only FDA-approved device for proximal aortic neck
More informationRobert F. Cuff, MD FACS SHMG Vascular Surgery
Robert F. Cuff, MD FACS SHMG Vascular Surgery Objectives To become familiar with the commercially available fenestrated EVAR graft Discuss techniques to increase success Review available data to determine
More informationEducation for Self Administration of Intravenous Therapy HOME IV THERAPY PICC. Portacath
HOME IV THERAPY PICC Portacath Who To contact Cardio-Respiratory Integrated Specialist Services (CRISS) Office hours 0800 1630 hours Ph: 364 0167 Weekends and after hours, phone Christchurch Hospital operator
More informationHome Health Foundation, Inc. To create more permanent IV access for patients undergoing long term IV therapy.
PROCEDURE ORIGINAL DATE: 06/99 Revised Date: 09/02 Home Health Foundation, Inc. SUBJECT: PURPOSE: MIDLINE CATHETER INSERTION To create more permanent IV access for patients undergoing long term IV therapy.
More informationSpineJack. Ø 5.8 mm Ø 5.0 mm Ø 4.2 mm. Controlled Anatomical Restoration
SpineJack Ø 5.8 mm Ø 5.0 mm Ø 4.2 mm Controlled Anatomical Restoration Introducing Controlled the Anatomical Surgical Restoration Technique SpineJack The SpineJack System is designed for the Anatomical
More informationAXIOS Stent and Electrocautery Enhanced Delivery System. Quick Reference Guide
AXIOS Stent and Electrocautery Enhanced Delivery System Quick Reference Guide AXIOS Stent (front and side views) UPN Codes Flange Diameter (mm) Lumen Diamter (mm) Saddle Length (mm) Catheter OD (Fr) Catheter
More informationEVOGAM. Information for patients Evogam 2014 NZ Patient Brochure Update v11
EVOGAM Information for patients 11881 Evogam 2014 NZ Patient Brochure Update v11 Information for patients and caregivers about EVOGAM This booklet is designed to help you follow the training you will have
More informationROTABLATORTM. Peripheral. Rotational Atherectomy System. Quick Reference Cards
Peripheral ROTABLATORTM Rotational Atherectomy System Quick Reference Cards Technical Assistance: 1.800.949.6708 Customer Service: 1.888.272.1001 Complaints: 1.800.811.3211 Setup Video: www.bostonscientific.com/rotablatorsetup
More informationThe New World of (Micro)Plugs. Jafar Golzarian Professor of Radiology and Surgery University of Minnesota Medical Center
The New World of (Micro)Plugs Jafar Golzarian Professor of Radiology and Surgery University of Minnesota Medical Center Jafar Golzarian, M.D. Stock: Embomedics Speakers Bureau: Boston Scientific, AngioDynamics,
More informationThe SplitWire Percutaneous Transluminal Angioplasty Scoring Device. Instructions for Use
The SplitWire Percutaneous Transluminal Angioplasty Scoring Device Instructions for Use Contents Contains one (1) SplitWire device. Sterile. Sterilized with ethylene oxide gas. Radiopaque. For single use
More informationRadRx Your Prescription for Accurate Coding & Reimbursement Copyright All Rights Reserved.
Interventional Radiology Coding Case Studies Prepared by Stacie L. Buck, RHIA, CCS-P, RCC, CIRCC, AAPC Fellow President & Senior Consultant Week of June 4, 2018 Thrombolysis, Thrombectomy & Angioplasty
More informationBryan-Dumon Series II Rigid Bronchoscope and Stent Placement Kit USER MANUAL
Bryan-Dumon Series II Rigid Bronchoscope and Stent Placement Kit USER MANUAL Table of Contents Bryan-DUmon Series II rigid bronchoscope 1. 2. 3. 4. 5. Diagram and Overview Universal Barrel Bronchial and
More informationInstructions for Use ANGIOGUARD XP Emboli Capture Guidewire System
10257072-3 Instructions for Use ANGIOGUARD XP Emboli Capture Guidewire System 1 2 This page has been This page has been 3 CAUTION: Federal (USA) law restricts this device to sale by or on the order of
More informationAERO DV Tracheobronchial Direct Visualization Stent System
AERO DV Tracheobronchial Direct Visualization Stent System Review Instructions For Use Before Using This System. Single Use Only Non-sterile MR Conditional CONTENTS Instructions for Use...............................
More informationGuide Wires design and selection Abbott Vascular. All rights reserved.
Guide Wires design and selection the cardiac catheter was...the key in the lock Cournand AF, Nobel lecture December 11, 1956; nowadays, the coronary guidewire is the master key to all locks Colombo et
More informationChronic Total Occlusion (CTO) Technologies
to receive our latest news and key activities. Chronic Total Occlusion (CTO) Technologies Re-open vital channels LinkedIn page Follow us on CORDIS EMEA OUTBACK LTD Re-Entry Catheter True Lumen Re-Entry
More informationFinally, the Control You Need to Deliver Accurate Treatment
Finally, the Control You Need to Deliver Accurate Treatment LIFESTREAM Covered Stent. has joined BD When you reach for a balloon expandable stent, you require accuracy. The LIFESTREAM Balloon Expandable
More informationA Novel Technique of Microcatheter Shaping with Cerebral Aneurysmal Coil Embolization: In Vivo Printing Method
Journal of Neuroendovascular Therapy 2017; 11: 48 52 Online November 28, 2016 DOI: 10.5797/jnet.tn.2016-0051 A Novel Technique of Microcatheter Shaping with Cerebral Aneurysmal Coil Embolization: In Vivo
More informationRadRx Your Prescription for Accurate Coding & Reimbursement Copyright All Rights Reserved.
Interventional Radiology Coding Case Studies Prepared by Stacie L. Buck, RHIA, CCS-P, RCC, CIRCC, AAPC Fellow President & Senior Consultant INDICATION: Abdominal aortic aneurysm. INTERVENTIONAL RADIOLOGIST:
More informationDistal Radius Surgical Technique Guide
Distal Radius Surgical Technique Guide About IlluminOss IlluminOss minimally invasive procedure incorporates a PET or Dacron balloon catheter that is delivered through a small pathway into the intramedullary
More informationCP STENT. Large Diameter, Balloon Expandable Stent
CP STENT Large, Expandable CP STENT OPTIONS 12mm to Expansion 26mm to Expansion CP Matrix (number of zigs) 1.6 2.2 2.8 3.4 3.9 4.5 5 5.5 6 12 14 15 16 18 20 22 24 26 28 30 CP Details: CP is composed of
More informationOptimal Techniques for Obtaining Large Caliber Arterial Access
Optimal Techniques for Obtaining Large Caliber Arterial Access Gerald Yong MBBS (Hons) FRACP FSCAI Interventional Cardiologist Royal Perth Hospital Western Australia APCASH 11 October 2014 Disclosure Statement
More informationWallFlex Biliary Metal Stents
WallFlex Biliary Metal Stents Please Note: These steps are intended to be for general guidance only. For complete instructions for use, indications, contraindications and warnings, please refer to the
More informationNuDEL STENT DELIVERY SYSTEM COARCTATION OF THE AORTA INSTRUCTIONS FOR USE
NuDEL STENT DELIVERY SYSTEM COARCTATION OF THE AORTA AND RIGHT VENTRICULAR OUTFLOW TRACT INSTRUCTIONS FOR USE General Instructions.. Page 2 Coarctation Indication..Page 5 Right Ventricular Outflow Tract
More information