Ask your surgeon for more information about Natrelle and visit GummyImplants.com

Size: px
Start display at page:

Download "Ask your surgeon for more information about Natrelle and visit GummyImplants.com"

Transcription

1 The #1 surgeon-preferred gummy implant collection in the US* Two-stage breast reconstruction starts with Natrelle 133 Series Tissue Expanders Natrelle 133 Series Tissue Expanders are made to match Natrelle INSPIRA Cohesive breast implants. This means that the tissue expander creates a space customized for the breast implant. A precise match ensures the confidence you and your surgeon expect with Natrelle. The #1 surgeon-preferred tissue expander* With 30 years of clinical experience. *Based on surgeon survey data, April 2017 (N = 89). Go gummy with Natrelle INSPIRA Cohesive breast implants Get a look and feel that s uniquely you with Natrelle INSPIRA Cohesive the gummiest round gel breast implant in the US. Designed to maintain its shape and upper pole fullness when held upright in your hand Designed for a full look Based on implant performance testing; significance inside the body has not been established. Your questions, answered 1 2 What s gummy about the gel in Natrelle INSPIRA Cohesive? The technical term for what s inside Natrelle INSPIRA Cohesive is highly cohesive gel that means that the gel has a gummy-like consistency that sticks together, holds its shape, and doesn t squish as much as other less cohesive silicone gels. How is Natrelle INSPIRA Cohesive different from other implants? Natrelle INSPIRA Cohesive is the most cohesive (gummiest) round gel breast implant in the US. This highly cohesive, gummy implant is designed to maintain its upper pole fullness. In other words, when you hold the implant upright in your hand, it s designed to keep its fullness at the top. Significance inside the body has not been established. Ask your surgeon for more information about Natrelle and visit GummyImplants.com

2 Natrelle Breast Implants Important Information Who may get breast implants? Natrelle Breast Implants are approved for women for the following: Breast augmentation for women at least 22 years old for silicone-filled implants. Breast augmentation for women at least 18 years old for saline-filled implants. Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. IMPORTANT SAFETY INFORMATION Who should NOT get breast implants? Women with active infection anywhere in their body. Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions. Women who are currently pregnant or nursing. What should I know before getting breast implants? Breast implants are not lifetime devices, and not necessarily a one-time surgery. Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implant(s) removed and not replaced, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which may be permanent. Breast implants may affect your ability to breast-feed, either by reducing or eliminating milk production. Rupture of a silicone-filled breast implant is most often silent and may not be detected by you or your doctor. You should have an MRI 3 years after your surgery and then every 2 years after that for as long as you have your breast implants to determine if rupture is present. If implant rupture is noted on an MRI, you should have the implant removed, with or without replacement. With breast implants, a routine screening mammography and self-examinations for breast cancer will be more difficult. Ask your doctor to help you distinguish the implant from your breast tissue. Symptoms of a ruptured implant may be hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening. Tell your doctor of these symptoms and remove ruptured implants. Inform any other doctor who treats you of the presence of your implants to minimize the risk of damage to the implants. What should I tell my doctor? Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher: Autoimmune diseases (for example, lupus and scleroderma). A weakened immune system (for example, currently taking drugs that weaken the body s natural resistance to disease). Planned chemotherapy following breast implant placement. Planned radiation therapy to the breast following breast implant placement. Conditions or medications that interfere with wound healing and blood clotting. Reduced blood supply to breast tissue. Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your surgeon prior to surgery. Patients with a diagnosis of depression or other mental health disorders should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery. What are some complications with breast implants? Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring, or wrinkling/rippling. Talk to your doctor about other complications. Talk to your doctor. For more information see the patient brochures at To report a problem with Natrelle Breast Implants, please call Allergan at Natrelle Breast Implants are available by prescription only Allergan. All rights reserved. All trademarks are the property of their respective owners. Natrelle.com NAT /

3 The #1 surgeon-preferred s oft tissue matrix* *Based on surgeon survey data, April 2017 (N = 89). Get the soft tissue support you need with AlloDerm SELECT Regenerative Tissue Matrix Mastectomy may result in weakened or thin tissue, which may require reinforcement during breast reconstruction. Your surgeon may recommend AlloDerm SELECT Regenerative Tisse Matrix (an acellular dermal matrix, or ADM) as part of your breast reconstruction procedure. AlloDerm SELECT is a soft tissue matrix that helps to reinforce weakened or thin tissue. Ask your surgeon if AlloDerm SELECT is right for you. Your questions, answered 1 What is AlloDerm SELECT Regenerative Tissue Matrix? AlloDerm SELECT is a soft tissue matrix that helps to reinforce weakened or thin tissue. Your surgeon may recommend AlloDerm SELECT Regenerative Tisse Matrix (an acellular dermal matrix, or ADM) as part of your breast reconstruction procedure. 2 Is AlloDerm SELECT right for me? Only your plastic surgeon can determine if AlloDerm SELECT is right for you. Every woman s journey is different, and what might be a good fit for one person, may not be right for the next. Ask your care team which products are best for your unique situation. Ask your surgeon for more information about AlloDerm SELECT

4 Indication and Important Safety Information for AlloDerm SELECT Regenerative Tissue Matrix AlloDerm SELECT Regenerative Tissue Matrix is an acellular dermal matrix that comes from donated human tissue and is processed to remove cells while maintaining structure. AlloDerm SELECT RTM is intended for the replacement or repair of inadequate or damaged soft tissue. AlloDerm SELECT RTM is not a dural substitute or for veterinary use. Each package of AlloDerm SELECT RTM is for one-time use in one patient. Patients who are sensitive to any of the antibiotics listed on the product package or Polysorbate 20 should not receive AlloDerm SELECT RTM. AlloDerm SELECT RTM is available only through a licensed physician. Potential risks of surgical procedures associated with the use of a tissue matrix include, but are not limited to: wound or systemic infection, seroma, dehiscence, hypersensitive, allergic or other immune response, sloughing or failure of the tissue matrix, and disease transmission. This information is not intended to replace a discussion with your surgeon. It does not describe all the potential risks associated with the use of tissue matrix in surgical procedures. Every patient s situation is different, so please consult with your surgeon to determine if the use of AlloDerm SELECT RTM is right for you. Please see AlloDerm SELECT RTM Instructions for Use. AlloDerm SELECT and its design are trademarks of LifeCell Corporation, an Allergan affiliate. Allergan and its design are trademarks of Allergan, Inc Allergan. All rights reserved. Allergan.com ALD /

5 The #1 surgeon-preferred fat transfer system* *Based on surgeon survey data, April 2017 (N = 89). Shape your breasts naturally with REVOLVE System REVOLVE System is a system for fat transfer that allows your surgeon to collect fat from one area of your body (such as your abdomen) and process that fat for transfer to your breasts. After processing with REVOLVE System, surgeons can use this purified fat to help replace the volume and shape that you ve lost after your mastectomy. Ask your surgeon if REVOLVE System is right for you. Fat transfer can enhance your overall breast shape by adding fullness where you need it the most Closed system design cleans and purifies fat in one sterile environment from start to finish Your questions, answered 1 How can fat transfer with REVOLVE System help me achieve my desired breast reconstruction results? Women who undergo a mastectomy are left with very thin tissue. Your surgeon may suggest fat transfer with REVOLVE System to replace the volume you ve lost and provide additional fullness. Ask your surgeon for more information about fat transfer with REVOLVE System

6 Indication and Important Safety Information for REVOLVE System The REVOLVE System is a single-use, sterile, disposable canister that is intended for processing, filtering, and transferring of autologous adipose tissue. The device is intended to be used by a physician to perform autologous fat grafting in aesthetic body-contouring procedures. Autologous fat-grafting should not be performed in the presence of any disease process that adversely affects wound healing and in patients who are in poor overall health. Some common adverse effects associated with autologous fat transfer are asymmetry, over- and/or undercorrection of the treatment site, tissue lumps, bleeding, and scarring. The REVOLVE System is available only through a licensed physician. This information is not intended to replace a discussion with your surgeon. It does not describe all the potential risks associated with fat grafting procedures. Every patient s situation is different, so please consult with your surgeon to determine if the use of REVOLVE System is right for you. Please see REVOLVE System Instructions for Use and User Manual. REVOLVE System and its design are trademarks of LifeCell Corporation, an Allergan affiliate. Allergan and its design are trademarks of Allergan, Inc Allergan. All rights reserved. Allergan.com RVL /

ALLODERM SELECT ALLODERM SELECT RESTORE

ALLODERM 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 information

Information and resources for African Americans living with multiple myeloma and their caregivers

Information and resources for African Americans living with multiple myeloma and their caregivers For African Americans living with Multiple Myeloma Information and resources for African Americans living with multiple myeloma and their caregivers Standing in the Gaap: An initiative created to help

More information

DIRECTIONS FOR USE. NATRELLE 133 Tissue Expanders. MAGNA-FINDER Xact. Directions for Use. with Magna-Site. Injection Sites

DIRECTIONS FOR USE. NATRELLE 133 Tissue Expanders. MAGNA-FINDER Xact. Directions for Use. with Magna-Site. Injection Sites DIRECTIONS FOR USE Directions for Use NATRELLE 133 Tissue Expanders with Magna-Site Injection Sites MAGNA-FINDER Xact & 21G Needle Infusion Set CAUTION: U.S. Federal law restricts this device to sale by

More information

DIRECTIONS FOR USE. NATRELLE 133 Plus Tissue Expanders. MAGNA-FINDER Xact. Directions for Use. with Magna-Site. Injection Sites

DIRECTIONS FOR USE. NATRELLE 133 Plus Tissue Expanders. MAGNA-FINDER Xact. Directions for Use. with Magna-Site. Injection Sites DIRECTIONS FOR USE Directions for Use NATRELLE 133 Plus Tissue Expanders with Magna-Site Injection Sites MAGNA-FINDER Xact & 21G Needle Infusion Set CAUTION: U.S. Federal law restricts this device to sale

More information

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed physician.

CAUTION: 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 information

Repliform. Tissue Regeneration Matrix. Instructions for Use. Distributed by:

Repliform. Tissue Regeneration Matrix. Instructions for Use. Distributed by: Repliform Tissue Regeneration Matrix Instructions for Use Distributed by: Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 Processed from Donated Human Tissue by: LifeCell

More information

TRELLIS COLLAGEN RIBBON

TRELLIS 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 information

Form-Stable Cohesive Gel Implants: Advantages and Technical Essentials

Form-Stable Cohesive Gel Implants: Advantages and Technical Essentials 02 Innov v1n3_r3 07-14 9/1/06 3:39 PM Page 7 Form-Stable Cohesive Gel Implants: Advantages and Technical Essentials William P. Adams, Jr., MD The advent of form-stable cohesive gel implants represents

More information

A GUIDE TO THIS REFLECTIONS B RESEARCH STUDY IF YOU RE FIGHTING BREAST CANCER, YOU RE NOT ALONE

A GUIDE TO THIS REFLECTIONS B RESEARCH STUDY IF YOU RE FIGHTING BREAST CANCER, YOU RE NOT ALONE A GUIDE TO THIS REFLECTIONS B327-02 RESEARCH STUDY IF YOU RE FIGHTING BREAST CANCER, YOU RE NOT ALONE Do you have breast cancer that has spread to outside the breast? Has your tumor tested positive for

More information

MEDICATION GUIDE RIBAVIRIN TABLETS Rx Only Read this Medication Guide carefully before you start taking ribavirin tablets and read the Medication

MEDICATION GUIDE RIBAVIRIN TABLETS Rx Only Read this Medication Guide carefully before you start taking ribavirin tablets and read the Medication MEDICATION GUIDE RIBAVIRIN TABLETS Rx Only Read this Medication Guide carefully before you start taking ribavirin tablets and read the Medication Guide each time you get more ribavirin tablets. There may

More information

Meso BioMatrix Acellular Peritoneum Matrix RECOMMENDED TECHNIQUE GUIDE. Recreating harmonious bodies for a new vision of rebirth.

Meso BioMatrix Acellular Peritoneum Matrix RECOMMENDED TECHNIQUE GUIDE. Recreating harmonious bodies for a new vision of rebirth. Meso BioMatrix Acellular Peritoneum Matrix RECOMMENDED TECHNIQUE GUIDE Recreating harmonious bodies for a new vision of rebirth. 1 DISCOVER SEBBIN Sebbin is a 30 years-established company with a peerless

More information

PRO-STIM Injectable Inductive Graft Containing DONATED HUMAN TISSUE

PRO-STIM Injectable Inductive Graft Containing DONATED HUMAN TISSUE PRO-STIM Injectable Inductive Graft Containing DONATED HUMAN TISSUE 137835-5 The following languages are included in this packet: English (en) For additional information please contact the manufacturer

More information

MIIG INJECTABLE Graft The following languages are included in this packet:

MIIG 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 information

Platelet Concentrate in Total Knees BIOLOGICS. This brochure is for International use only. It is not for distribution in the United States.

Platelet Concentrate in Total Knees BIOLOGICS. This brochure is for International use only. It is not for distribution in the United States. Platelet Concentrate in Total Knees BIOLOGICS This brochure is for International use only. It is not for distribution in the United States. Platelet Concentrate in Total Knees Total Knee Arthroplasty Total

More information

LEARN. about. Please see Important Safety Information on pages 3-5 and enclosed full Prescribing Information.

LEARN. about. Please see Important Safety Information on pages 3-5 and enclosed full Prescribing Information. LEARN about on pages 3-5 and enclosed 2 3? What is ZARXIO (filgrastim-sndz)? ZARXIO is a man-made form of granulocyte colony-stimulating factor (G-CSF) called filgrastim. G-CSF is a substance produced

More information

The Role of Adult Stem Cells in Personalized and Regenerative Medicine

The Role of Adult Stem Cells in Personalized and Regenerative Medicine The Role of Adult Stem Cells in Personalized and Regenerative Medicine Christopher J. Neill, Director of Corporate Operations American CryoStem Corporation Objective To illustrate the potential benefits

More information

PHYSICIAN OFFICE BILLING INFORMATION SHEET FOR IMLYGIC (talimogene laherparepvec)

PHYSICIAN OFFICE BILLING INFORMATION SHEET FOR IMLYGIC (talimogene laherparepvec) PHYSICIAN OFFICE BILLING INFORMATION SHEET FOR IMLYGIC (talimogene laherparepvec) INDICATION IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable

More information

CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES

CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES Informing Decisions About New Health Technologies Issue 162 July 2017 Patient-Controlled Carbon Dioxide Tissue Expansion for Breast Reconstruction Image courtesy

More information

2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process

2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process Quality ID #21 (NQF 0268): Perioperative Care: Selection of Prophylactic Antibiotic First OR Second Generation Cephalosporin National Quality Strategy Domain: Patient Safety 2018 OPTIONS FOR INDIVIDUAL

More information

Myeloma Bone Disease Current and Future Treatment. A Publication of The Bone and Cancer Foundation

Myeloma Bone Disease Current and Future Treatment. A Publication of The Bone and Cancer Foundation Myeloma Bone Disease Current and Future Treatment A Publication of The Bone and Cancer Foundation What Is Multiple Myeloma? Multiple Myeloma is a cancer that results from a malignant change in a particular

More information

Document number (version): RMP.NUS (3.0) Page 63 of 95

Document number (version): RMP.NUS (3.0) Page 63 of 95 VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology The immune system is the body s frontline defence to fight infection by viruses, bacteria, and other foreign organisms/materials.

More information

STEM CELLS BONE FRACTURE

STEM CELLS BONE FRACTURE BIOLOGY UNIT 2 MRS. CATHERINE JACKSON STEM CELLS BONE FRACTURE By AYESHA SYED 10C 2 Stem Cell (Introduction) Stem cells are undifferentiated cells that have not yet become a specialised cell, with a specific

More information

Discover TruPRP. PRP the way you want it.

Discover TruPRP. PRP the way you want it. Discover TruPRP PRP the way you want it. Discover TruPRP Discover the quality of Magellan TruPRP. The Magellan technology provides an automated dual spin processing system that can deliver (PRP) Platelet

More information

MEDPOR. Orbital Floor

MEDPOR. Orbital Floor MEDPOR Orbital Floor Orbital Fracture Repair Available in a variety of shapes, sizes, and configurations, MEDPOR and MEDPOR TITAN Implants provide surgeons with an expanding range of options for reconstruction

More information

Mutations : D: a permanent change made to one section of DNA

Mutations : D: a permanent change made to one section of DNA Mutations : distinguish between somatic and germ mutations explain the different types of mutations explain how jumping genes influence diversity identify diseases caused by chromosomal mutations (Downs,

More information

For personal use only

For personal use only 1047 Elwell Court, Palo Alto CA 94303 USA Tel (US): +1 (650) 390 9000 Tel (AU): 1-800-778-662 Fax: +1 650 390 9007 www.airxpanders.com ASX ANNOUNCEMENT AirXpanders issues Shareholder Newsletter PALO ALTO,

More information

Artist Proof: Clotalyst. Autologous Serum Collection System

Artist Proof: Clotalyst. Autologous Serum Collection System Artist Proof: 01-15-10 Clotalyst Autologous Serum Collection System Clotalyst Autologous Serum The kit is designed for the preparation of autologous serum that is to be mixed with PRP and autograft or

More information

Surgical Adhesives in Facial Plastic Surgery

Surgical Adhesives in Facial Plastic Surgery Surgical Adhesives in Facial Plastic Surgery Dean M. Toriumi, Victor K. Chung, Quintin M. Cappelle University of Illinois at Chicago Chicago, IL Supplement to Toriumi DM, Chung VK, Cappelle QM. Surgical

More information

Correspondence should be addressed to Christopher Vashi;

Correspondence should be addressed to Christopher Vashi; Plastic Surgery International, Article ID 704323, 7 pages http://dx.doi.org/10.1155/2014/704323 Clinical Study Clinical Outcomes for Breast Cancer Patients Undergoing Mastectomy and Reconstruction with

More information

Adipose rabbit mesenchymal stem cells for the treatment of the chronic scar tissue of the vocal cords

Adipose rabbit mesenchymal stem cells for the treatment of the chronic scar tissue of the vocal cords Adipose rabbit mesenchymal stem cells for the treatment of the chronic scar tissue of the vocal cords Dr. Vasiliki E Kalodimou, Head of Flow Cytometry-Research and Regenerative Medicine Department, IASO-Maternity

More information

PLTW Biomedical Science Medical Interventions Course Outline

PLTW Biomedical Science Medical Interventions Course Outline Follow the fictitious Smith family as you learn about the prevention, diagnosis, and treatment of disease. Play the role of biomedical professionals to analyze case information and diagnose and treat your

More information

Tabbed Tissue Expanders Improve Breast Symmetry Scores in Breast Reconstruction

Tabbed Tissue Expanders Improve Breast Symmetry Scores in Breast Reconstruction Tabbed Tissue Expanders Improve Breast Symmetry Scores in Breast Reconstruction Nima Khavanin, Madeleine J Gust, David W Grant, Khang T Nguyen, John YS Kim Division of Plastic and Reconstructive Surgery,

More information

REFERENCE CODE GDME1016FPR PUBLICATION DATE JULY 2013 HERNIA REPAIR CURRENT AND FUTURE PLAYERS

REFERENCE CODE GDME1016FPR PUBLICATION DATE JULY 2013 HERNIA REPAIR CURRENT AND FUTURE PLAYERS REFERENCE CODE GDME1016FPR PUBLICATION DATE JULY 2013 HERNIA REPAIR 1 1... 2 1.1 List of Tables... 7 1.2 List of Figures... 11 2 Introduction... 14 2.1 Catalyst... 15 3 Competitive Assessment... 16 3.1

More information

Quality ID #262: Image Confirmation of Successful Excision of Image-Localized Breast Lesion National Quality Strategy Domain: Patient Safety

Quality ID #262: Image Confirmation of Successful Excision of Image-Localized Breast Lesion National Quality Strategy Domain: Patient Safety Quality ID #262: Image Confirmation of Successful Excision of Image-Localized Breast Lesion National Quality Strategy Domain: Patient Safety 2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY MEASURE

More information

BAXTER UNVEILS DESIGN ENHANCEMENTS TO FLOSEAL AND TISSEEL HEMOSTATIC AGENTS AT AORN MEETING

BAXTER UNVEILS DESIGN ENHANCEMENTS TO FLOSEAL AND TISSEEL HEMOSTATIC AGENTS AT AORN MEETING FOR IMMEDIATE RELEASE Media Contact Beth Mueller, (224) 948-5353 media@baxter.com Investor Contact Clare Trachtman, (224) 948-3085 BAXTER UNVEILS DESIGN ENHANCEMENTS TO FLOSEAL AND TISSEEL HEMOSTATIC AGENTS

More information

DuraGen Secure. Dural Regeneration Matrix

DuraGen Secure. Dural Regeneration Matrix DuraGen Secure Dural Regeneration Matrix DESCRIPTION DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dural defects. DuraGen Secure Dural Regeneration Matrix is an easy

More information

Smouldering myeloma. Myeloma Infosheet Series. Other related conditions. Infoline:

Smouldering myeloma. Myeloma Infosheet Series. Other related conditions. Infoline: Smouldering myeloma This Infosheet provides information on what smouldering myeloma is, how it is diagnosed, what the treatment is and will explain the link between smouldering myeloma and active myeloma.

More information

Treatment: Nutrition and Medication

Treatment: Nutrition and Medication INFLAMMATORY BOWEL DISEASE (IBD): CROHN S DISEASE Treatment: Nutrition and Medication While there is no cure for Crohn s disease, there are a number of options to help treat it. The goals of treatment

More information

SCIENCE. VALUE. INNOVATION.

SCIENCE. VALUE. INNOVATION. SCIENCE. VALUE. INNOVATION. OUR STORY TELA Bio, a surgical reconstruction company, was created out of the desire to do things differently. Combining the drive and innovation of a start-up with a seasoned

More information

Diagnosis for Open Wounds as a Result of Cancer Resection

Diagnosis for Open Wounds as a Result of Cancer Resection Diagnosis for Open Wounds as a Result of Cancer Resection December 15, 2016 What diagnosis code do we use when we are reconstructing a defect after the Moh s surgeon, or someone else removed the cancer?

More information

MITRAL VALVE REPAIR BACKGROUND

MITRAL 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 information

For personal use only

For personal use only Investor Update July 2012 Regenerative medicine is fundamentally changing the way we think about the treatment of a wide range of diseases, injuries and tissue defects. ReCell Spray- On- Skin, as one of

More information

Functional Assessment and Clinical Outcome

Functional Assessment and Clinical Outcome Tissue Engineering Functional Assessment and Clinical Outcome STEVEN A. GOLDSTEIN Orthopaedic Research Laboratories, Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, Michigan 48109,

More information

RegenKit THT. Autologous Platelet Rich Plasma (A-PRP) Reference Guide. Biologics. Concentrated on Healing

RegenKit THT. Autologous Platelet Rich Plasma (A-PRP) Reference Guide. Biologics. Concentrated on Healing RegenKit THT Autologous Platelet Rich Plasma (A-PRP) Reference Guide Biologics Concentrated on Healing Step I: Collect Whole Blood RegenKit THT Simple 4-Step Process e single use RegenKit THT is designed

More information

Infra-red s Effect on Dentistry and the Immune System Presented by Dr. John L. Tate

Infra-red s Effect on Dentistry and the Immune System Presented by Dr. John L. Tate Infra-red s Effect on Dentistry and the Immune System Presented by Dr. John L. Tate New Technology Available Hello, my name is Dr. John L. Tate, a practicing dental surgeon, in Spartanburg, South Carolina.

More information

Arthrex Angel TM System. Indication-specific PRP and PRF gel preparations

Arthrex Angel TM System. Indication-specific PRP and PRF gel preparations Arthrex Angel TM System Indication-specific PRP and PRF gel preparations Arthrex Angel TM System The Arthrex Angel TM System is a revolutionary production system for platelet-rich plasma (PRP) formulations

More information

Alliqua BioMedical Investor Presentation August 2017 NASDAQ: ALQA

Alliqua BioMedical Investor Presentation August 2017 NASDAQ: ALQA Alliqua BioMedical Investor Presentation August 2017 NASDAQ: ALQA Forward Looking Statements Safe Harbor Statement This presentation contains forward-looking statements. Forward-looking statements are

More information

Health Reimbursement Account Preventive Care Program for Participants and Spouses

Health Reimbursement Account Preventive Care Program for Participants and Spouses Health Reimbursement Account Preventive Care Program for Participants and Spouses EFFECTIVE DATE: JANUARY 1, 2016 The Trustees have established the Health Reimbursement Account Preventive Care Program

More information

Germany Tissue Engineered - Skin Substitutes Market Outlook to 2020

Germany Tissue Engineered - Skin Substitutes Market Outlook to 2020 Germany Tissue Engineered - Skin Substitutes Market Outlook to 2020 Reference Code: GDMECC0884DB Publication Date: October 2014 Page 1 1 Table of Contents 1 Table of Contents... 2 1.1 List of Tables...

More information

Agenzia Italiana del Farmaco

Agenzia Italiana del Farmaco Agenzia Italiana del Farmaco European Regulation on Advanced Therapies Cristina Pintus Head of European Relations Unit and Coordinator of the Advanced Therapy Project Italian Medicines Agency Proposal

More information

This Infosheet explains what Monoclonal Gammopathy of Undetermined Significance (MGUS) is and how it is diagnosed and managed.

This Infosheet explains what Monoclonal Gammopathy of Undetermined Significance (MGUS) is and how it is diagnosed and managed. MGUS This Infosheet explains what Monoclonal Gammopathy of Undetermined Significance (MGUS) is and how it is diagnosed and managed. What is MGUS? Monoclonal gammopathy of undetermined significance, or

More information

Future bound. Philips Ingenuity Core

Future bound. Philips Ingenuity Core Future bound Philips Ingenuity Core High reliability Low-dose, high-quality imaging and coverage, and the ability to personalize image quality* patient by patient. Expect excellence in routine imaging,

More information

Heat Transfer in Laser Tumor Excision

Heat Transfer in Laser Tumor Excision BEE 453: COMPUTER AIDED ENGINEERING Professor Ashim K. Datta May 7, 2004 Heat Transfer in Laser Tumor Excision Submitted by Alan Chen, Edwin Cheung, Steven Lee, John Picuri, Tsung Li Shih Contents Executive

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Evaluation of Medicines for Human Use London, 29 July 2004 CPMP/BPWG/1089/00 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE CLINICAL INVESTIGATION OF PLASMA

More information

Design and Development of Biomedical and Surgical Instruments in Biomedical Applications

Design and Development of Biomedical and Surgical Instruments in Biomedical Applications Chapter XX Design and Development of Biomedical and Surgical Instruments in Biomedical Applications Jeremy (Zheng) Li Additional information is available at the end of the chapter http://dx.doi.org/0./chapterdoi

More information

MEDICAL WASTE MANAGEMENT STUDY NOTES

MEDICAL WASTE MANAGEMENT STUDY NOTES MEDICAL WASTE MANAGEMENT STUDY NOTES UNIT 1 INTRODUCTION Hospital and other health care establishment has a duty of care for the environment and for public health and have particular responsibility in

More information

Guideline on core SmPC for human fibrinogen products

Guideline on core SmPC for human fibrinogen products 23 July 2015 EMA/CHMP/BPWP/691754/2013 Rev 1 Committee for Medicinal Products for Human Use (CHMP) Draft Agreed by Blood Products Working Party 27 November 2013 Adoption by CHMP for release for consultation

More information

Wisconsin Folk Medicine

Wisconsin Folk Medicine Wisconsin Folk Medicine Waterford Chiropractic Office Dr. G.E. Nielsen * docnielsen@aol.com Fax: (262) 534-2363 * Ph: (262) 534-3767 Internet Website: www.docnielsen.com 505 Aber Drive * P.O. Box 86 Waterford,

More information

CapSure Permanent Fixation System

CapSure 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 information

NEXT GENERATION ECM-BASED ALLOGRAFT TECHNOLOGY:

NEXT GENERATION ECM-BASED ALLOGRAFT TECHNOLOGY: NEXT GENERATION ECM-BASED ALLOGRAFT TECHNOLOGY: Potent biological scaffolds strategically control stem cell fate and function, allowing our allografts to harness the regenerative potential of patient s

More information

Update on the IVDR. Sue Spencer

Update on the IVDR. Sue Spencer Update on the IVDR Sue Spencer Caution The new regulations are draft the principles have now been agreed but the Annexes are subject to minor changes Further details will be added later pre and post application

More information

Coordinated Primary Options Service. DVT Management Plan. Management options using Dabigatran or Warfarin

Coordinated Primary Options Service. DVT Management Plan. Management options using Dabigatran or Warfarin Coordinated Primary Options Service DVT Management Plan Management options using Dabigatran or Warfarin Name NHI DOB Ethnicity Gender Address Contact Information Mobile Home Treatment commenced date *CPO

More information

Participant Copy. No. Participation is voluntary. Your decision will not affect your health care at Mayo Clinic in any way.

Participant Copy. No. Participation is voluntary. Your decision will not affect your health care at Mayo Clinic in any way. Name and Clinic Number IRB # 08-007049 00 Consent form approved July 16, 2015; This consent valid through July 15, 2016; 1. General Information About This Research Study Study Title: Mayo Clinic Biobank

More information

Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS

Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS Key Topics Definitions Essential Principles Classification Conformity Assessment Framework License to Manufacture, Import,

More information

Clinical Policy: Humate-P (Antihemophiliac Factor/von Willebrand Factor Complex Human) Reference Number: CP.MP.404

Clinical Policy: Humate-P (Antihemophiliac Factor/von Willebrand Factor Complex Human) Reference Number: CP.MP.404 Clinical Policy: (Antihemophiliac Factor/von Willebrand Factor Complex Human) Reference Number: CP.MP.404 Effective Date: January 2008 Last Review Date: 12/16 See Important Reminder at the end of this

More information

3. Human Biomedical Research. Defining Human Biomedical Research

3. Human Biomedical Research. Defining Human Biomedical Research PART B: SECTION III: HUMAN BIOMEDICAL RESEARCH HUMAN BIOMEDICAL RESEARCH 3. Human Biomedical Research Defining Human Biomedical Research 3.1. In this section, we consider what kinds of human biomedical

More information

HydroSet. Injectable HA Bone Substitute

HydroSet. Injectable HA Bone Substitute HydroSet Injectable HA Bone Substitute The Latest Advancement in Bone Substitute Technology Fast Setting Injectable or Manual Implantation Osteoconductive Excellent Wet-field Characteristics Isothermic

More information

The Power in You. TM

The Power in You. TM RegenKit THT Autologous Platelet Rich Plasma (A-PRP) The Power in You. TM Biologics Concentrated on Healing RegenKit THT Autologous Platelet Rich Plasma (A-PRP) The RegenKit THT is designed to be used

More information

PREVELEAK Surgical sealant

PREVELEAK Surgical sealant PREVELEAK Surgical sealant Rx only Instructions for Use DEVICE DESCRIPTION PREVELEAK Surgical sealant (PREVELEAK) is a sealant developed to seal suture holes formed during surgical repair of the circulatory

More information

Guidelines for the use of blood warming devices(aabb) Reference: 2002 AABB

Guidelines for the use of blood warming devices(aabb) Reference: 2002 AABB Guidelines for the use of blood warming devices(aabb) Reference: 2002 AABB 1 Hypothermia Introduction Induced by rapid, large-volume transfusion of refrigerated blood components A potential source of serious

More information

Comprehensive Solutions

Comprehensive Solutions Comprehensive Solutions in Ultrasound-guided Breast Biopsy ATEC Vacuum-assisted Breast Biopsy System Celero Vacuum-assisted, Spring loaded Core Breast Biopsy Device Tru-Core II Spring loaded Core Breast

More information

CAREGIVER GUIDE themmrf.org

CAREGIVER GUIDE themmrf.org MULTIPLE MYELOMA CAREGIVER GUIDE themmrf.org ABOUT THE MULTIPLE MYELOMA RESEARCH FOUNDATION The Multiple Myeloma Research Foundation (MMRF) was established in 1998 by identical twin sisters Kathy Giusti

More information

HEMOSTASIS IN SURGERY

HEMOSTASIS IN SURGERY Greco D.P.- M.D.-F.A.C.S. Director SSD Day Surgery Torino 25-27 november 2010 HEMOSTASIS IN SURGERY The normal physiological response that prevents significant blood loss following vascular injury is called

More information

YOUR OWN LIFE

YOUR OWN LIFE YOUR OWN LIFE Stromal Tissue (ST), a Regenerative Source There is a worldwide consensus that the isolation and collection of regenerative Mesenchymal Stem Cells (MSC s) from differentiated body tissues

More information

07/30/2013. Record of Revisions IRB Page 1 of 17

07/30/2013. Record of Revisions IRB Page 1 of 17 Current Protocol Version 7.1 (Continuing Review) Approved July 30, 2013 Version 7.1 (Amendment) September 6, 2012 Version 7.0 (Continuing Review) July 30, 2012 Version 6.0 (Continuing Review) July 30,

More information

Santen Acquisition of InnFocus, Developer of MicroShunt Glaucoma Implant Device

Santen Acquisition of InnFocus, Developer of MicroShunt Glaucoma Implant Device Santen Acquisition of InnFocus, Developer of MicroShunt Glaucoma Implant Device Akira Kurokawa President & CEO August 2, 2016 Copyright 2016 Santen Pharmaceutical Co., Ltd. All rights reserved. 1 External

More information

Perioperative management of patients on warfarin requiring elective surgery Dr K Boyd, Mrs S Doyle

Perioperative management of patients on warfarin requiring elective surgery Dr K Boyd, Mrs S Doyle CLINICAL GUIDELINES ID TAG Title: Author: Speciality / Division: Directorate: Perioperative management of patients on warfarin requiring elective surgery Dr K Boyd, Mrs S Doyle Haematology Acute Date Uploaded:

More information

Introducing a new take on efficient workflow: Deeply integrated clinical applications

Introducing a new take on efficient workflow: Deeply integrated clinical applications Clinical Applications Introducing a new take on efficient workflow: Deeply integrated clinical applications The EXPERIENCE of TRUE CLINICAL APPLICATIONS While developments in image acquisition technology

More information

VIII. Validation Evaluation Comparative Chart Application Fields of PRP Advantages of MiroPRP for skin treatments MicroPRP and Mico-Mesotherapy

VIII. Validation Evaluation Comparative Chart Application Fields of PRP Advantages of MiroPRP for skin treatments MicroPRP and Mico-Mesotherapy The New Technology for Safe Platelet Activation INDEX I. Blood Composition II. What is PRP Therapy? III. Growth Factors Present in PRP IV. Why is PRP concentration significant? V. How are Platelets Activated?

More information

Section 8. To introduce the basic theory and principles of collecting blood for Intraoperative Cell Salvage (ICS)

Section 8. To introduce the basic theory and principles of collecting blood for Intraoperative Cell Salvage (ICS) Section 8 Practicalities Blood Collection Aim To introduce the basic theory and principles of collecting blood for Intraoperative Cell Salvage (ICS) Learning Outcomes To identify the equipment used for

More information

CRM and the Future of Healthcare Engagement

CRM and the Future of Healthcare Engagement CRM and the Future of Healthcare Engagement CRM and the Future of Healthcare Engagement As a growing number of healthcare organizations are discovering, the most common technology in healthcare the electronic

More information

European Regenerative Medicine Firms & Their Strategic Approaches. Michael Morrison University of York

European Regenerative Medicine Firms & Their Strategic Approaches. Michael Morrison University of York European Regenerative Medicine Firms & Their Strategic Approaches Michael Morrison University of York OVERVIEW Creating the European RM Universe of firms Characterizing the European RM Universe Strategic

More information

Tissue Expander Overfilling: Achieving New Dimensions of Customization in Breast Reconstruction

Tissue Expander Overfilling: Achieving New Dimensions of Customization in Breast Reconstruction Tissue Expander Overfilling: Achieving New Dimensions of Customization in Breast Reconstruction The Harvard community has made this article openly available. Please share how this access benefits you.

More information

Immunotherapy in myeloma

Immunotherapy in myeloma Immunotherapy in myeloma This Horizons Infosheet contains information on immunotherapy, a type of treatment being investigated in myeloma. The Horizons Infosheet series provides information relating to

More information

Presenting SURGICEL Powder

Presenting SURGICEL Powder SURGICEL Powder Presenting SURGICEL Powder Built to stop continuous, broad-surface oozing fast1,2 The next generation of SURGICEL Absorbable Hemostats SURGICEL Powder efficiently and effectively controls

More information

All Savers Wellness. Capability Overview.

All Savers Wellness. Capability Overview. All Savers Wellness. Capability Overview. All Savers Wellness. powered by myallsaversmember.com STAY WELL BE WELL GET WELL Activity Trackers and FIT Rewards. Use a wearable activity tracker to track steps,

More information

ADVANCING THE ART OF SINGLE-STAGE REPAIR

ADVANCING THE ART OF SINGLE-STAGE REPAIR ADVANCING THE ART OF SINGLE-STAGE REPAIR PREPERITONEAL PLACEMENT GORE BIO-A WEB PTFE Knit GORE BIO-A WEB OVERVIEW GORE SYNECOR Preperitoneal Biomaterial is designed specifically for preperitoneal, retromuscular

More information

BIOLOGIC MEDICATIONS IN THE TREATMENT OF IBD. crohnsandcolitis.ca

BIOLOGIC MEDICATIONS IN THE TREATMENT OF IBD. crohnsandcolitis.ca BIOLOGIC MEDICATIONS IN THE TREATMENT OF IBD crohnsandcolitis.ca BIOLOGIC MEDICATIONS IN THE TREATMENT OF IBD INFLAMMATION AND IMMUNITY IN CROHN S AND COLITIS Inflammation is the body s normal and natural

More information

Radiography Curriculum Analysis

Radiography Curriculum Analysis Program Number Program Name Date / /20 Radiography Curriculum Analysis DIRECTIONS: Determine the course(s) in which each of the following content area is covered and enter the course number(s) and/or title(s).

More information

IT S A GLOBAL LEADER. IT S PROVEN.

IT S A GLOBAL LEADER. IT S PROVEN. isert Preloaded IOL System IT S A GLOBAL LEADER. IT S PROVEN. IT S isert. isert delivers the combination of simple operation, outstanding visual quality, and procedural efficiency. LEADERSHIP, WITH VISION

More information

Molecular Diagnostics. Castle Medical LLC.

Molecular Diagnostics. Castle Medical LLC. Molecular Diagnostics Castle Medical LLC. What is DNA testing? Pharmacogenomics is a scientific disciple that deals with the influence of patient s genotype on drug response. Objective: to deliver the

More information