RePneu (Lung Volume Reduction) Coil System Instructions For Use
|
|
- Dwain Craig
- 6 years ago
- Views:
Transcription
1 RePneu (Lung Volume Reduction) Coil System Instructions For Use MPS Medical Product Service GmbH Borngasse Braunfels Germany Tel: (+49) Fax: (+49) PneumRx, Inc. 530 Logue Avenue Mountain View, CA USA Tel: (+1) Fax: (+1)
2 Description The PneumRx RePneu Endobronchial Coil System is an implantable device designed to improve lung function in patients with emphysema. The System consists of sterile RePneu Coils and a sterile, disposable, single-procedure RePneu Coil Delivery System consisting of a Cartridge, Catheter, Guidewire and Forceps. The PneumRx RePneu Coil System is designed for bilateral treatment using a therapeutic bronchoscope with a 2.8 mm working channel and fluoroscopy for visualization beyond the bronchoscope. The nitinol Coil should be placed in subsegmental airways and is designed to tether adjacent airways open to reduce airway collapse and air trapping. The Coil tensions the surrounding tissue, which increases elastic recoil and redirects air to healthier portions of the lung. Coils are available in several sizes to accommodate various airway lengths. The intended use of the Delivery System is to safely deliver the Coils. A single Delivery System can be used to deliver multiple Coils to the same patient. The Guidewire serves as a guide for the Catheter by facilitating advancement of the Catheter into airways and also indicates the approximate Coil length for the selected airway. The Catheter delivers the straightened Coil through the bronchoscope and to the airway. The Cartridge straightens the Coil, couples to the Catheter and facilitates Coil delivery into the Catheter. The Forceps clasps the proximal end of the Coil for delivery through the Catheter. The Forceps can also be used to remove the Coil. Each Coil is individually pouched in its own protective packaging shell. The Cartridge, Guidewire, Catheter and Forceps are pouched together and packaged in a box as the Delivery System. The Delivery System is sterilized by Ethylene Oxide (EtO) and the Coil is sterilized by Electron Beam (E-Beam). Coil Catheter Forceps Guidewire Cartridge Figure 1. Components of the System Indications for Use The RePneu Coil System is intended to improve exercise capacity, lung function and quality of life in patients with both heterogeneous and homogeneous emphysema. Contraindications The RePneu Coil System is contraindicated for: Patients for whom bronchoscopic procedures are contraindicated Patients with evidence of active infection in lungs Patients with known allergies to nitinol (nickel-titanium) or its constituent metals Patients with severe pulmonary hypertension defined by right ventricular systolic pressure 50 mm Hg via echocardiogram and/or right heart catheterization 2
3 Warnings Do not use the device if the package is damaged, as sterility may be compromised. Store this product in a dry place. Failure to follow these Instructions for Use may cause damage to Coil. Discard and replace the Coil if needed. The System should be used with caution and only after careful consideration, especially in patients: - With a history of recurrent clinically significant respiratory infections. - Requiring long term high dose oral steroids. - With hypercapnia. There have been reports of fatal hemoptysis in patients undergoing Coil treatment. In at least one of these cases, the patient was undergoing anticoagulant treatment. Therefore, while a causal relationship has not been established, the use of anticoagulant drugs in patients with Coil treatment should be carefully managed, as it may be associated with an increased bleeding risk: - To decrease the risk of serious pulmonary bleeding events, use of antiplatelet (e.g., aspirin, clopidogrel) or anticoagulant therapy (e.g., warfarin, NOAC s) should be stopped for seven (7) days prior to and seven (7) days following the Coil implantation procedure. - The benefits and risks of initiation or continuing use of antiplatelet or anticoagulant medications in patients who have undergone Coil treatment should be carefully assessed. Do not implant RePneu Coils in any area of the lung exhibiting bronchiectasis. Coil therapy has not been evaluated in patients with clinically significant bronchiectasis. To decrease the risk of serious pulmonary bleeding events, Coil implantation should be performed in such patients only after careful consideration, avoiding any suspect areas of the lung. Do not attempt to resterilize any of the System components. All components are provided sterile and are designed and tested for single use only. If the surface finish of the Coil is scratched, nicked or otherwise compromised, re-use could result in functional failure or implant fracture. The System is not designed to be cleaned or sterilized for re-use, and thus re-use could result in infection or infectious disease. In addition, the Coil and Delivery System will not function as intended if reused after being subjected to re-sterilization that requires elevated temperatures. The safety and effectiveness of RePneu therapy has not been evaluated in the following patient populations: - Patients >75 years of age - Children under the age of 18 - Pregnant or lactating women - Patients who have not quit smoking - FEV 1 <15% of predicted value - Patients with DLCO 20% of predicted value - Patients with giant bullae - Patients with pulmonary hypertension - Patients with serious bleeding disorders - Patients who have had prior lung transplant, LVRS, median sternotomy, or lobectomy - Patients with alpha-1 antitrypsin deficiency - Patients with congestive heart failure or recent myocardial infarction - Patients with moderate to severe chronic inflammatory autoimmune disorders that have a tendency to cause an overactive immune system response Caution The following instructions are provided as a general informational guide for the safe, effective use of the RePneu Coil System. Medical practitioners should always rely on their clinical experience and judgment, including current sterile techniques and surgical practices. 3
4 Precautions Read all labels and instructions prior to use. Ignoring or not fully recognizing or understanding the Instructions For Use may result in procedural difficulties and/or complications. The RePneu Coil System is intended to be used with a therapeutic bronchoscope with a 2.8 mm minimum inner diameter working channel and a 65 cm maximum working length. Caution Use with incompatible bronchoscopes may result in equipment or device damage. Magnetic Resonance Imaging (MRI) Information MR Conditional The RePneu Coil is MR Conditional and this information applies to the entire family of RePneu Coils (i.e., all coil sizes). Non-clinical testing and MRI simulations were performed to identify the worst case conditions that were used to demonstrate that the RePneu Coil is MR Conditional. A patient with this device can be scanned safely, immediately after placement under the following conditions: Static magnetic field of 1.5- or 3-Tesla, only Spatial magnetic gradient field of 5,000-Gauss/cm (extrapolated) or less Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode of operation for the MR system MRI-Related Heating In non-clinical testing, the RePneu Coil produced the following temperature rises during MRI performed for 15-min of scanning (i.e., per pulse sequence) in 1.5-Tesla/64-MHz (Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active-shielded, horizontal field scanner) and 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR systems: MR system reported, whole body averaged SAR Calorimetry measured values, whole body averaged SAR Highest temperature change Temperature scaled to whole body averaged SAR of 2-W/kg 1.5-Tesla 2.9-W/kg 2.1-W/kg 5.4 C 3.7 C Artifact Information The maximum artifact size as seen on the gradient echo pulse sequence at 3-Tesla extends approximately 10-mm relative to the size of the shape of the RePneu Coil. 3-Tesla 2.9-W/kg 2.7-W/kg 3.2 C 2.2 C Complications 4 Potential complications include, but are not limited to, the following: Bleeding (local) Bronchospasm COPD exacerbation Cough Death Hemoptysis Hoarseness Infection (including pneumonia) Pain Pneumothorax Respiratory acidosis Shortness of breath Tissue hyperplasia or other localized tissue reaction at Coil implant site Tissue perforation/dissection
5 Recommended Procedure Coil Deployment Instructions 1. Insert the bronchoscope into the patient s bronchus. 2. Identify the airways leading to the diseased parenchyma, and navigate the bronchoscope to the selected airway. a. Treatment should target the most damaged lobe (upper or lower) in each lung. b. Start deploying Coils in the segment which presents the most difficult access first and progress to less difficult segments. c. The recommended treatment strategy is to deploy Coils in upper lobes or Coils in lower lobes. d. Discontinue deploying additional Coils if increased resistance is felt while advancing the proximal end of the Coil into the lung. 3. Position the bronchoscope in the segmental airway at the ostium leading to sub-segmental airways. 4. Remove both the Guidewire and the Catheter together from the packaging hoop. 5. Insert the Catheter and Guidewire into the working channel of the bronchoscope. 6. Advance the Catheter to the tip of the bronchoscope and then advance the Guidewire into the targeted airway (see Figure 2) Caution: Use fluoroscopy to visualize the Guidewire when it is beyond the visual range of the bronchoscope. Turn on fluoroscopy when the fluoroscopy marker band enters the Catheter hub. Radiopaque tip of Guidewire Radiopaque tip of Catheter Bronchoscope Figure 2. Advancing Guidewire into Targeted Airways a. Gently navigate the Guidewire into the distal airways under fluoroscopic guidance until the tip reaches the pleura or suddenly curves from a straight path. Caution: Do not puncture pleura or advance the Guidewire against resistance. 7. Retract the Guidewire tip by grasping it at the proximal end and withdrawing at least 4 cm from the Catheter hub. 8. Hold the Guidewire position fixed relative to the bronchoscope and advance the Catheter distally to the tip of the Guidewire (see Figure 3). Caution: Fluoroscopy should remain on to make sure the Guidewire does not move during Catheter advancement. Caution: Do not force the Catheter around a sharp bend on the Guidewire. Caution: If unable to advance the Catheter to the distal end of the Guidewire, pull the Guidewire back to be aligned with the tip of the Catheter. Do not force the Catheter. Align radiopaque tips of Guidewire & Catheter Bronchoscope Figure 3. Aligning Catheter Tip with Guidewire Tip 5 9. Use the radiopaque markers on the Guidewire to measure the airway length (distance from tip of Guidewire to end of bronchoscope). 10. Guidance on Coil selection a. The markers indicate the minimum recommended Coil size to be used.
6 b. Do not count the wire tip as a marker for Coil selection. c. If three markers are seen, use Coil #3 (150mm length). d. If two markers are seen, select Coil #2 (125mm length) or longer. e. If a single marker is seen, select Coil #1 (100mm length) or longer. f. If no marker is seen, advance the Guidewire to the pleura. If a marker is seen, deploy a Coil #1. Do not deploy a Coil if still no marker is seen. 11. Turn fluoroscopy off and remove the Guidewire from the Catheter while maintaining the Catheter position. 12. Remove the Forceps and the Cartridge from the packaging. 13. Insert the Forceps into and through the Cartridge, making certain that the Forceps exit the Luer lock end of the Cartridge as shown in Figure 4. Luer Lock Cartridge Fluoroscopy Marker Band (95.5 cm) Lock Handle Figure 4. Advancing Forceps through Cartridge 14. Remove the plastic protective shell containing the chosen size of Coil from the pouch. 15. Grasp the proximal ball of the Coil with the Forceps. a. Open the Forceps jaws, and grasp the Coil by closing the Forceps jaws around the proximal ball. b. Lock the Forceps jaws closed (press the blue locking tab towards the handle until it snaps) to prevent releasing the Coil. 16. Seat the Cartridge into the opening of the plastic protective shell (see Figure 5). Slowly pull the Coil from the plastic protective shell into the Cartridge until the Coil is completely inside the Cartridge. Caution: Do not pull any portion of the Coil out of the proximal end of the Cartridge.Pushing the Coil back into the Cartridge may cause damage. Cartridge should fit into the plastic protective shell 6 Figure 5. Pulling Coil into Cartridge 17. Connect the Cartridge to the Luer lock hub of the Catheter and lock into place. 18. Deliver the Coil into the Catheter by advancing the Forceps and Coil. Caution: Grip the Forceps no more than 5 cm from the proximal end of the Cartridge to prevent kinking while advancing. Note: Always use fluoroscopy when the fluoroscopy marker band enters the Cartridge. 19. Align the distal end of the Coil with the distal end of the Catheter and verify the position of the Coil via fluoroscopy. 20. Have an assistant hold the bronchoscope fixed relative to the patient. Caution: Do not move the bronchoscope position during the deployment procedure.
7 21. Coil Deployment a. Deploy the Coil by distally advancing the Forceps. Advance the Coil out of the distal end of the Catheter until at least the first loop is positioned in the target airway. b. Retract the Catheter while maintaining a slight constant pressure to advance the Forceps forward until the Forcep jaws are visible approximately 2 cm distal to the end of the bronchoscope. Maintain Forceps position and continue to retract the Catheter into the bronchoscope (see Figure 6). Distal Ball Coil Catheter Deploying Coil Bronchoscope 7 Figure 6. Observing the Partially Deployed Coil 22. Verify the position of the Coil prior to unlocking the Forceps and releasing the Coil. a. Ideally the proximal end of the Coil is in the subsegmental airway or more distal. Note: If the Coil is already released from the Forceps but the proximal ball is not in the segmental airway or more distal, it is recommended to deploy all Coils before attempting to reposition. The Coil proximal ends adjust distally throughout the procedure. If a Coil placement is still not ideal at the end of the treatment, recapture the proximal ball with the Forceps and follow steps below. b. If the proximal ball needs to be advanced ~1 cm, advance the Catheter 2 cm past the Forceps jaws, then gently advance the Catheter and Forceps together. Repeat steps 21 b and 22 a. c. If the proximal ball needs to be advanced 1-2 cm, hold the Forceps and Coil position fixed relative to the bronchoscope and advance the Catheter distally to resheath up to half of the Coil. Retract the Catheter while moving the Forceps more distally to redeploy the Coil. d. If the proximal ball needs to be advanced more than 2 cm, recapture and redeploy the Coil. i) Resheath the Coil until it is fully captured in the Catheter. ii) Withdraw the Coil by proximally retracting the Forceps until the Coil is within the Cartridge. iii) Unlock the Luer lock and remove the Cartridge, Coil and Forceps as a single unit, while leaving the Catheter in place. iv) Introduce the Guidewire into the Catheter and reposition the Catheter so the Coil can be redeployed. 23. To release the Coil, gently retract the Forceps approximately 1 cm to create slight tension between the Forceps and the Coil. Unlock the Forceps and open the jaws. Close the Forceps jaws, and confirm that the proximal ball has been released before turning the fluoroscopy off. Caution: The Forceps jaws cannot open if they are within the Catheter. The Forceps jaws must be at least 1 cm distal to the Catheter and the bronchoscope to release the Coil. 24. Unlock the Cartridge from the Catheter (Luer lock), and remove the Cartridge and Forceps from the Catheter. 25. Pull the distal tip of the catheter into the bronchoscope. Note: The Catheter may continue to be used to repeat Steps 5 to 25 to deploy additional Coils. Coil Removal subsequent bronchoscopy (within 2 months of initial treatment) 1. Navigate a 2.0 mm working channel bronchoscope and identify the airway in which the proximal end of the Coil resides. 2. Insert the Forceps through the bronchoscope channel.
8 3. Locate the Coil and capture the proximal ball. Note: This procedure should be performed using fluoroscopy. 4. Lock the Forceps. 5. Advance the scope distally, as far as possible, while proximally retracting the Forceps to remove the Coil from the airway and into the bronchoscope working channel. Caution: Do not reuse the Coil. Symbol Key for Product Labels Consult Instructions For Use (IFU) Lot number Catalog number Use by date Sterilized by Ethylene Oxide to SAL of 10-6 Sterilized by Electron Beam irradiation to SAL of 10-6 By prescription only Magnetic resonance imaging conditional Single patient use only, do not reuse Latex-free product Do not use if package or product is damaged Keep dry Manufacturer Authorized Representative in the European Economic Area (EEA) Instructions for Use Contains n individual coil(s) per package 8 This document is copyrighted with all rights reserved. Under copyright laws, it may not be copied in whole or in part or reproduced in any other media without the express written permission of PneumRx. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original. Under the law, copying includes translation into another language. Please note that while every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. PneumRx TM, RePneu TM, LVRC TM, and the PneumRx logo are registered trademarks of PneumRx, Inc. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. In addition, the RePneu Coil is subject of U.S., EP and other patents and patent applications. PneumRx, Inc. is a BTG International group company.
RePneuTM (Lung Volume Reduction) Coil System
RePneuTM (Lung Volume Reduction) Coil System INSTRUCTIONS FOR USE 1 MPS Medical Product Service GmbH Borngasse 20 35619 Braunfels Germany Tel: (+49) 6442 962073 Fax: (+49) 6442 962074 PneumRx, Inc. 4255
More informationRePlay Hemostasis Clip
RePlay Hemostasis Clip Instructions for use. Read carefully prior to use. Caution: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician. Diversatek Healthcare Corporate
More informationTo Whom It May Concern:
To Whom It May Concern: DeRoyal Foley Catheters with Temperature Sensors have been tested for safe use in magnetic resonance environments at 1.5 and 3.0 Tesla according to ASTM International F2052, Standard
More informationRapidPort EZ Access Port Kit DIRECTIONS FOR USE (DFU)
RapidPort EZ Access Port Kit DIRECTIONS FOR USE (DFU) RapidPort EZ Access Port Kit Ref. No. C-2304 Standard RapidPort EZ Access Port Kit Ref. No. C-2306 Large RapidPort EZ Access Port Kit INTRODUCTION
More informationMagnetic Resonance Imaging (MRI) Safety for Boston Scientific Products. 1. WALLSTENT Iliac Endoprosthesis with Unistep Plus Delivery System
Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products Table of Contents 1. WALLSTENT Iliac Endoprosthesis with Unistep Plus Delivery System.1 2. WALLSTENT RP Endoprosthesis (Transhepatic
More informationLAP-BAND System Access Port II Kit
LAP-BAND System Access Port II Kit DIRECTIONS FOR USE (DFU) Access Port Needle Access Port Priming Needle Access Port II End Plug Band Priming Needle Stainless Steel Connector Tubing LAP-BAND System Access
More informationAzur Peripheral Coil System Helical HydroCoil Embolization System (Detachable) Instructions for Use
Azur Peripheral Coil System Helical HydroCoil Embolization System (Detachable) Instructions for Use DEVICE DESCRIPTION The Detachable Azur Peripheral Coil System (Azur system) consists of a coil implant
More informationMRI Information. MRI Safe The following AMS product does not contain metallic components and therefore is considered MRI Safe.
August 2015 MRI Information Several Magnetic Resonance Imaging (MRI) studies have concluded that the AMS products listed below will not produce additional risks to patients in association with MRI procedures
More informationMRI Information. MRI Safe The following AMS product does not contain metallic components and therefore is considered MRI Safe.
August 2015 MRI Information Several Magnetic Resonance Imaging (MRI) studies have concluded that the AMS products listed below will not produce additional risks to patients in association with MRI procedures
More informationExamples of component location and routing are shown on the next page:
The Cleveland FES Center MetroHealth Medical Center Hamann Building Room 601 2500 MetroHealth Drive Cleveland, Ohio 44109 (216) 778-3480 (216) 778-4259 (fax) www.fescenter.org Memo To: Re: Whom it may
More informationGDC Detachable Coils, GDC 360o Detachable Coils, Matrix2 Detachable Coils, and Target Detachable Coils
GDC Detachable Coils, GDC 0o Detachable Coils, Matrix Detachable Coils, and Target Detachable Coils Magnetic Resonance Imagining (MRI) Compatibility (Neurovascular Use) Non-clinical testing and analysis
More informationAcoustic Pulse Thrombolysis Treatment
Acoustic Pulse Thrombolysis Treatment In-Service Presentation Acoustic Pulse Thrombolysis treatment is a minimally invasive system for accelerating thrombus dissolution. FORWARD-LOOKING STATEMENT This
More informationRapidPort EZ Port Applier DIRECTIONS FOR USE (DFU)
RapidPort EZ Port Applier DIRECTIONS FOR USE (DFU) RapidPort EZ Port Applier Ref. No. C-20390 RapidPort EZ Port Applier INTRODUCTION The RapidPort EZ Port Applier is an optional accessory for the LAP-BAND
More informationASAHI Masters PARKWAY SOFT. ASAHI Masters PARKWAY HF
ASAHI Masters PARKWAY SOFT Microcatheter ASAHI Masters PARKWAY HF Microcatheter SYMBOLS 1 English 2 AMK-DT207 Ver.1.40 / 11TS028 SYMBOLS Legal manufacturer Consult instructions for use Do not use if package
More informationEkoSonic MACH4 Endovascular Device Instructions for Use
EkoSonic MACH4 Endovascular Device Instructions for Use Indications for Use The EkoSonic Endovascular System is indicated for the: Ultrasound facilitated, controlled and selective infusion of physician-specified
More informationMRI Conditional Devices and Patient Safety. Outline. MRI Labeling: Objects 8/3/13 1. David W. Jordan, Ph.D. Senior Medical Physicist
MRI Conditional Devices and Patient Safety David W. Jordan, Ph.D. Senior Medical Physicist 8/3/13 1 Outline MRI Conditional Overview Spatial Gradient Hazards RF SAR Hazards Device Registries MRI Labeling:
More informationASAHI Masters PARKWAY HF KIT
ASAHI Masters PARKWAY HF KIT Guide Wire Pre-loaded Microcatheter SYMBOLS 1 English 2 AMK-DT202 Ver.1.30 / 11TS023 SYMBOLS Legal manufacturer GC Minimum guiding catheter I.D. Do not use if package is damaged
More informationInstructions for Use Reprocessed Coronary Sinus Diagnostic Electrophysiology Catheter
Reprocessed by Instructions for Use Reprocessed Coronary Sinus Diagnostic Electrophysiology Catheter Reprocessed Device for Single Use STERILE Explanation of Symbols Federal Law in the USA restricts this
More informationEasyClip Xpress Sterile staple solution. Operative technique
EasyClip Xpress Sterile staple solution Operative technique Sterile staple solution Table of contents Indications 3 Operative technique 4 This publication sets forth detailed recommended procedures for
More information3M Tegaderm PICC/CVC Securement Device + I.V. Advanced Securement Dressing Product Description
3M Tegaderm PICC/CVC Securement Device + I.V. Advanced Securement Dressing Product Description 3M Tegaderm PICC/CVC Securement Device + I.V. Advanced Securement Dressing ( Securement System ) is designed
More informationARROW EDGE. Antegrade-tunneled chronic hemodialysis catheter
ARROW EDGE Antegrade-tunneled chronic hemodialysis catheter ARROW EDGE HEMODIALYSIS CATHETERIZATION SET CONTENTS: 1 Catheter: 15 Fr. 1 Arrow SmartSeal Hemostatic Peelable Dialysis Sheath: 16 Fr. 1 Spring
More informationCoding and Billing Guide
To control prolonged air leaks of the lung or significant air leaks likely to become prolonged following lobectomy, segmentectomy and LVRS Coding and Billing Guide This guide is intended to provide coding
More informationRESPIRATORY SENSING LEAD
RESPIRATORY SENSING LEAD 4340 Technical Manual ONLY Explanation of symbols on product or package labeling Caution, consult accompanying documents eifu indicator Consult electronic instructions for use
More informationCoding and Billing Guide
To control prolonged air leaks of the lung or significant air leaks likely to become prolonged following lobectomy, segmentectomy and LVRS Coding and Billing Guide This guide is intended to provide coding
More informationCoding and Billing Guide
To control prolonged air leaks of the lung or significant air leaks likely to become prolonged following lobectomy, segmentectomy and LVRS Coding and Billing Guide This guide is intended to provide coding
More informationCoding and Billing Guide
To control prolonged air leaks of the lung or significant air leaks likely to become prolonged following lobectomy, segmentectomy and LVRS Coding and Billing Guide This guide is intended to provide coding
More informationHANDLING OF WRIGHT MEDICAL DISPOSABLE PROPHECY TM ANKLE INSTRUMENTS
HANDLING OF WRIGHT MEDICAL DISPOSABLE PROPHECY TM ANKLE INSTRUMENTS 153290-0 The following languages are included in this packet: English (en) For additional languages, visit our website www.wright.com
More informationTRUFILL DCS ORBIT Detachable Coil System
ORBIT Conforming to Your Complex Needs Excellent Conformability and Concentric Filling for Outstanding Packing Density ORBIT Full range of Mini Complex and new Tight Distal Loop Technology coils Our Complex
More informationEndovascular Device Testing A Survey of Requirements for Product Validation
MET A4 1p Endovascular Device Testing Info Sheet-02.qxp_MET A4 1p Endovascular Device Testing Info Sheet.qxp 05/04/2016 09:58 Page 1 Endovascular Device Testing A Survey of Requirements for Product Validation
More informationComfort your patient deserves. Strength you demand.
POLYSITE LOW PROFILE HYBRID PORTS Comfort your patient deserves. Strength you demand. We never settle because you never settle. Throughout our 35-year history, clinicians and patients have benefited from
More informationINSTRUCTIONS FOR USE FOR:
INSTRUCTIONS FOR USE FOR: en English INSTRUCTIONS FOR USE GORE ENFORM INTRAPERITONEAL BIOMATERIAL Carefully read all instructions prior to use. Observe all instructions, warnings, and precautions noted
More informationPRODUCT NOTIFICATIONS
PRODUCT NOTIFICATIONS Medtronic Minimally Invasive Therapies Metallic Staple Composition Notification In response to inquiries concerning possible allergic reactions to the staples and clips in Medtronic
More informationNeuroPort Array PN 4382, 4383, 6248, and 6249 Instructions for Use
630 Komas Drive Suite 200 Salt Lake City UT 84108 USA P +1 801.582.5533 F +1 801.582.1509 www.blackrockmicro.com NeuroPort Array PN 4382, 4383, 6248, and 6249 Instructions for Use Revision 2.00 / LB-0612
More informationJanuary 13, Texas Medical Technologies, Inc. Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service January 13, 2016 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Texas
More informationBuilt for strength and security.
Built for strength and security. Instinct ENDOSCOPIC HEMOCLIP MEDICAL Trust your instincts. During critical hemostatic clipping procedures, you need an endoscopic hemoclip with features you can rely on.
More informationPage 1 of 6 Reprocessed by. Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Page 1 of 6 Reprocessed by Instructions for Use Reprocessed 3D Diagnostic Ultrasound Catheters Reprocessed Device for Single Use Caution: Federal (U.S.A.) law restricts this device to sale by or on the
More informationVASCULAR ACCESS PRELUDE SHEATH INTRODUCERS. Merit Medical s Innovative Family of Vascular Access Products A GREAT INTRODUCTION
VASCULAR ACCESS PRELUDE SHEATH INTRODUCERS Merit Medical s Innovative Family of Vascular Access Products A GREAT INTRODUCTION THE PRELUDE FAMILY OF SHEATH INTRODUCERS A comprehensive product line offering
More informationInstructions for Use Reprocessed Electrophysiology Catheter Cables
Reprocessed by Instructions for Use Reprocessed Electrophysiology Catheter Cables Reprocessed Device for Single Use STERILE Explanation of Symbols Federal Law in the USA restricts this device to sale by
More informationClinical Policy: Palivizumab (Synagis) Reference Number: ERX.SPA.124 Effective Date: Last Review Date: 08.17
Clinical Policy: (Synagis) Reference Number: ERX.SPA.124 Effective Date: 10.01.16 Last Review Date: 08.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationInstructions for Use Reusable Electrophysiology Catheter Cables
Processed by Instructions for Use Reusable Electrophysiology Catheter Cables STERILE Explanation of Symbols Federal Law in the USA restricts this device to sale by or on the order of a physician Sterilized
More informationCapSure Permanent Fixation System
CapSure Permanent Fixation System Permanent Fixation Redefined Advancing the Fixation Experience Recipient of 2015 SLS Innovations of the Year recognition. SOFT TISSUE REPAIR Right Procedure. Right Product.
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Synagis) Reference Number: CP.PHAR.16 Effective Date: 08.01.09 Last Review Date: 05.18 Line of Business: Commercial, Medicaid, HIM-Medical Benefit Revision Log See Important Reminder
More informationPOLYSITE Low Profile Hybrid Ports. Comfort your patient deserves. Strength you demand.
POLYSITE Low Profile Hybrid Ports Comfort your patient deserves. Strength you demand. The comfort your patient deserves. POLYSITE Hybrid Ports Port combines lightweight plastic body for comfort and a strong
More informationMIIG INJECTABLE Graft The following languages are included in this packet:
MIIG INJECTABLE Graft 128801-10 The following languages are included in this packet: English (en) Deutsch (de) Nederlands (nl) Français (fr) Español (es) Italiano (it) Português (pt) 中文 - Chinese (sch)
More informationUncompromised accuracy in neuroimaging and treatment
Uncompromised accuracy in neuroimaging and treatment 1 Helping clinicians improve patients lives. 2 Innovation built on strong foundations The tools used by the surgeon must be adapted to the task and,
More informationMedian Sternotomy Closure Utilizing Platelet Concentrate BIOLOGICS
Median Sternotomy Closure Utilizing Platelet Concentrate BIOLOGICS This brochure is for International use only. It is not for distribution in the United States. The Surgical Procedure: Median Sternotomy
More informationDisclosures. Role of the Pulmonologist in a Multidisciplinary Thoracic Program. Introduction. Access. None. Access
Role of the Pulmonologist in a Multidisciplinary Thoracic Program Disclosures None Ken Y. Yoneda, M.D. Professor of Medicine Division of Pulmonary and Critical Care University of California, Davis VA Northern
More informationINSTRUCTIONS FOR USE FOR:
INSTRUCTIONS FOR USE FOR: B I O M A T E R I A L en English INSTRUCTIONS FOR USE FOR GORE SYNECOR INTRAPERITONEAL BIOMATERIAL INDICATIONS The GORE SYNECOR Intraperitoneal Biomaterial device is intended
More informationInstructions for Use READY TO USE
READY TO USE Instructions for Use LifeCell Corporation One Millennium Way Branchburg, NJ 08876-3876 1.908.947.1215 1.800.367.5737 Fax: 1.908.947.1089 E-mail: customerservicegroup@lifecell.com www.lifecell.com
More informationSynagis (Palivizumab) Drug Prior Authorization Protocol
Line of Business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 Synagis (Palivizumab) Drug Prior Authorization Protocol This policy has been developed through review of medical
More informationSynagis. Synagis (palivizumab) Description. Section: Prescription Drugs Effective Date: July 1, 2016
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.20.04 Section: Prescription Drugs Effective Date: July 1, 2016 Subject: Synagis Page: 1 of 5 Last Review
More informationCAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed physician.
TM CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed physician. TABLE OF CONTENTS Section Port Styles 4 Description 5 Indications 5 Contraindications 5-6 Information
More informationThe SAVI TM Applicator: Breast Brachytherapy Training
The SAVI TM Applicator: Breast Brachytherapy Training SAVI Breast Brachytherapy Greater flexibility Treats the widest array of cavity & breast sizes Enhanced performance Eliminates skin spacing restrictions
More informationALLODERM SELECT ALLODERM SELECT RESTORE
ALLODERM SELECT ALLODERM SELECT RESTORE Regenerative Tissue Matrix Instructions for Use Processed from donated human tissue by: LifeCell Corporation One Millennium Way Branchburg, NJ 08876-3876 DESCRIPTION
More informationYukon Choice 4 DES Translumina - Allows natural healing
Coronary Stent System for Drug Application Translumina - Allows natural healing Allows natural healing Clinical history of the Yukon Stent Excellent clinical results with the Rapamycin Yukon Stent Dose-finding
More informationReplacement Heart Valve Product Description (Stented Tissue) Models Reference
Dear Imaging Center: This letter is in response to your inquiry concerning the safety of performing magnetic resonance (MR) procedures in patients who have been implanted with Edwards Lifesciences LLC
More informationInstructions for Use Reprocessed Masimo LNCS Pulse Oximeter Sensor. Reprocessed Device for Single Use
Reprocessed by Instructions for Use Reprocessed Masimo LNCS Pulse Oximeter Sensor Reprocessed Device for Single Use Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
More informationRüsch EZ-Blocker Endobronchial Blocker The next generation of one-lung ventilation
Rüsch EZ-Blocker Endobronchial Blocker The next generation of one-lung ventilation Rüsch EZ-Blocker Endobronchial Blocker Innovative, Intuitive, Secure Minimally invasive, next generation bronchus blocker,
More informationTREAT SMARTER. ACHIEVE MORE. When Treating Thrombus
TREAT SMARTER. ACHIEVE MORE. When Treating Thrombus Treat Smarter When you want fast, safe, predictable results EKOS Ultrasound Accelerated Thrombolysis Unlocks The Clot Without Ultrasonic Energy With
More informationReplacement Heart Valve Product Description (Stented Tissue) Models Reference
Dear Imaging Center: This letter is in response to your inquiry concerning the safety of performing magnetic resonance (MR) procedures in patients who have been implanted with Edwards Lifesciences LLC
More informationextended sewing ring Carpentier-Edwards bioprosthetic valved conduit , 21, 22
Dear Imaging Center: This letter is in response to your inquiry concerning the safety of performing magnetic resonance (MR) procedures in patients who have been implanted with Edwards Lifesciences (formerly
More information2018 PHYSICIAN CODING GUIDE ENB PROCEDURE
2018 PHYSICIAN CODING GUIDE ENB PROCEDURE The following coding scenarios are intended for illustrative purposes only and do not reflect every ENB coding scenario available, therefore, reimbursement will
More informationEkoSonic Endovascular System
EkoSonic Endovascular System Nursing In-Service EKOS Corporation is a BTG International group company US-EKO-1800192 Forward-looking statement This presentation and information communicated verbally to
More informationMerit Medical s Innovative Family. of Vascular Access Products. A Great Introduction
Merit Medical s Innovative Family of Vascular Access Products A Great Introduction Sheath Introducers The Prelude family of sheath introducers is a comprehensive product line offering excellent transitions,
More informationConformability without Compromise
Conformability without Compromise THE STANDARD IN Conformability AND Designed for flexibility and conformability in tortuous anatomy. Optimized aortic wall apposition in angulated arch anatomy without
More informationBIOTAPE XM TISSUE MATRIX The following languages are included in this packet:
BIOTAPE XM TISSUE MATRIX 150866-0 The following languages are included in this packet: English (en) Deutsch (de) Nederlands (nl) Français (fr) Español (es) Italiano (it) Português (pt) 中文 -Chinese (sch)
More informationReplacement Heart Valve Product Description (Stented Tissue) Models Reference
Dear Imaging Center: This letter is in response to your inquiry concerning the safety of performing magnetic resonance (MR) procedures in patients who have been implanted with Edwards Lifesciences LLC
More informationConformability without Compromise
Conformability without Compromise THE STANDARD IN Conformability AND Designed for flexibility and conformability in tortuous anatomy. Optimized aortic wall apposition in angulated arch anatomy without
More informationInstructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Universal Trocar Stability Sleeve. Reprocessed Device for Single Use.
Reprocessed by Instructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Universal Trocar Stability Sleeve Reprocessed Device for Single Use Caution: Federal (U.S.A.) law restricts this device to sale
More informationTRELLIS COLLAGEN RIBBON
TRELLIS COLLAGEN RIBBON 147321-1 English (en) The following languages are included in this packet: M Wright Medical Technology, Inc. 5677 Airline Rd. Arlington, TN 38002 USA www.wmt.com August 2012 Printed
More informationLeksell. Vantage Stereotactic System. Advancing stereotactic neurosurgery
Leksell Vantage Stereotactic System Advancing stereotactic neurosurgery Innovation built on strong foundations Since the founding of our company by Lars Leksell more than 45 years ago, Elekta has delivered
More information12 pericardial bioprostheses. 7300TFX Carpentier-Edwards bioprosthetic valved conduit
Dear Imaging Center: This letter is in response to your inquiry concerning the safety of performing magnetic resonance (MR) procedures in patients who have been implanted with Edwards Lifesciences (formerly
More informationMR Safety Evaluation of Orthopedic Devices: Why It's Important and How to Select Test Device Configuration
Safety Evaluation of Orthopedic Devices: Why It's Important and How to Select Test Device Configuration ORS Annual Meeting March 5, 2016 Beth Hess, PhD bhess@medinstitute.com www.medinstitute.com 1 MED
More informationInstructions for Use Reusable Ablation Catheter Cables
Processed by Instructions for Use Reusable Ablation Catheter Cables STERILE Explanation of Symbols Federal Law in the USA restricts this device to sale by or on the order of a physician Sterilized by Ethylene
More informationVascular. Making Best Use of Trinias Applications for Lower Extremity Interventional Procedures. 1. Introduction
Vascular Making Best Use of Trinias Applications for Lower Extremity Interventional Procedures Yasuhiro Takahashi, M.D. Department of Cardiology, The Fraternity Memorial Hospital Yasuhiro Takahashi 1.
More informationProcessed from Donated Human Tissue by LifeCell Corporation for KCI USA, Inc.
for wounds instructions for use Processed from Donated Human Tissue by LifeCell Corporation for KCI USA, Inc. marketed by KCI USA, Inc. San Antonio, TX 78219 USA 800.275.4524 www.kci1.com www.graftjacketbykci.com
More informationAcutus Medical Product Catalog 2016
The AcQMap Patient Electrode Kit consists of localization patches, an analog ground (AG) patch and ECG electrodes. The AcQMap Patient Electrode Kit is compatible with the AcQMap High Resolution 3D Imaging
More informationBeyond Tried. True. GuideLiner V3 Catheter Guide Extension Catheter With Half-Pipe Technology
Beyond Tried. True. GuideLiner V3 Catheter Guide Extension Catheter With Half-Pipe Technology Beyond Tried. True. In 2009, the GuideLiner Catheter revolutionized the concept of guide extension, creating
More informationFor special applications, we can also provide flexible and stiff nitinol guidewires with a longer and extra soft angled flexible safety tip.
HORIZONITINOL LIGATION GUIDEWIRES SYSTEM Threefold The name benefit you know, through the product layer technology you trust. SUPERIOR SAFETY All our nitinol guidewires, whether with a flexible or a stiff
More information- MRI Safety Update - RF Induced Heating. Society for Medical Innovation and Technology
- MRI Safety Update - RF Induced Heating presented to Society for Medical Innovation and Technology 11-14 May 2006 Pebble Beach, Monterey, CA, USA Jeffrey L. Helfer Objective of this Presentation Share
More information3000, 3000TFX 12 bioprostheses Carpentier-Edwards PERIMOUNT pericardial aortic and mitral
Dear Imaging Center: This letter is in response to your inquiry concerning the safety of performing magnetic resonance (MR) procedures in patients who have been implanted with Edwards Lifesciences (formerly
More informationCT Guided Electromagnetic Navigational Bronchoscopy
CT Guided Electromagnetic Navigational Bronchoscopy Duke Thoracoscopic Lobectomy Workshop March 21, 2018 Thomas A. D Amico MD Gary Hock Professor of Surgery Chief Thoracic Surgery, Chief Medical Officer
More informationReplacement Heart Valve Product Description (Stented Tissue) Models Reference
Dear Imaging Center: This letter is in response to your inquiry concerning the safety of performing magnetic resonance (MR) procedures in patients who have been implanted with Edwards Lifesciences LLC
More informationMITRAL VALVE REPAIR BACKGROUND
MITRAL VALVE REPAIR BACKGROUND THE PROBLEM Heart valves are held in place with string-like tendons that can stretch or break, keeping the heart from pumping properly. If left untreated, this can lead to
More informationPlatelet Function Testing Kits (catalogue numbers PSK-001, PSK-002, PSK-003)
Customer Information Sheet Platelet Function Testing Kits (catalogue numbers PSK-001, PSK-002, PSK-003) For remote testing of platelet function and the inhibitory effects of antiplatelet agents such as
More informationThis document is a preview generated by EVS
INTERNATIONAL STANDARD ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment Tracheal tubes and connectors Matériel d anesthésie et de réanimation respiratoire Sondes trachéales et raccords
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Arixtra) Reference Number: CP.PHAR.226 Effective Date: 07.01.18 Last Review Date: 02.18 Line of Business: Oregon Health Plan Coding Implications Revision Log See Important Reminder at
More informationISO INTERNATIONAL STANDARD. Cardiovascular implants Endovascular devices Part 3: Vena cava filters
INTERNATIONAL STANDARD ISO 25539-3 First edition 2011-12-01 Cardiovascular implants Endovascular devices Part 3: Vena cava filters Implants cardiovasculaires Dispositifs endovasculaires Partie 3: Filtres
More informationThe first of its kind
arrow nextstep retrograde The first of its kind TELEFLEX DIALYSIS ACCESS THE ARROW WAY The first of its kind Trusted brands make Teleflex a reliable and strong partner. Built on a solid tradition of innovation,
More informationInstructions for Use Reprocessed Balloon Inflation Devices
Reprocessed by Instructions for Use Reprocessed Balloon Inflation Devices Reprocessed Device for Single Use Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Synagis Page 1 of 13 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Synagis (palivizumab) Prime Therapeutics will review Prior Authorization Prior Authorization
More informationCT procedure with needle guidance for heptatocellular carcinoma
CT procedure with needle guidance for heptatocellular carcinoma Philips EPIQ image fusion and navigation case study Hepatocellular carcinoma (HCC) is a common condition worldwide. There has been increasing
More informationTRUFILL n-butyl Cyanoacrylate (n-bca) Liquid Embolic System
TRUFILL n-butyl Cyanoacrylate (n-bca) Liquid Embolic System Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350 USA 800 225 0460 +1 508 828 3000 LCN 206362-001/A 2009 Codman & Shurtleff,
More informationi-stat iccnet CHSA Edition 1.2 Page 1 of 7 i-stat Rosy Tirimacco / Paul Simpson
Page 1 of 7 i-stat Edition No: 1.2 Author: Rosy Tirimacco / Paul Simpson Date: January, 2012 Operative Date: January, 2012 Review Date: January, 2013 Location: Country Health SA Integrated Cardiovascular
More informationInstructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Dilating Tip Trocar with OPTIVIEW Technology
Reprocessed by Instructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Dilating Tip Trocar with OPTIVIEW Technology Reprocessed Device for Single Use Caution: Federal (U.S.A.) law restricts this device
More informationHANDLING OF WRIGHT DISPOSABLE PROPHECY ANKLE INSTRUMENTS
HANDLING OF WRIGHT DISPOSABLE PROPHECY ANKLE INSTRUMENTS 150870-0 English (en) The following languages are included in this packet: For additional information and translations please contact the manufacturer
More informationPulmonary Nodule Localization - Best Method. Jay M. Lee, M.D. Chief and Associate Professor Division of Thoracic Surgery, UCLA
Pulmonary Nodule Localization - Best Method Jay M. Lee, M.D. Chief and Associate Professor Division of Thoracic Surgery, UCLA 1 Localization of pulmonary nodules Lung cancer screening has lead to frequent
More informationComplex Left Atrial (CLA) Best Practices for Navigant
Complex Left Atrial (CLA) Best Practices Cavo-tricuspid Isthmus (CTI) Dependent Flutter Best Practices CTI Ablation Procedure Background RF Ablation of CTI dependent flutter is a standard procedure in
More informationPER F ORM ANC E b y d e s i g n. Pioneering TEVAR Therapy, Time and Time Again. CONFORMABLE
PER F ORM ANC E b y d e s i g n Pioneering TEVAR Therapy, Time and Time Again. CONFORMABLE T H O R A C I C E N D O P R O S T H E S I S Time-Tested Success For more than 16 years, the GORE TAG Device has
More informationCLINICAL GUIDELINE FOR THE SAFE DEPLOYMENT OF VASCULAR CLOSURE DEVICE 1. Aim/Purpose of this Guideline
CLINICAL GUIDELINE FOR THE SAFE DEPLOYMENT OF VASCULAR CLOSURE DEVICE 1. Aim/Purpose of this Guideline 1.1. This guideline applies to all medical practitioners trained in the deployment St Jude AngioSeal
More information