medical international research spirolab

Wellness Begins

With A Breath

Spirometry, Oximetry and Mobile-Health

As a global medical device leader in spirometry, oximetry, and telemedicine, our innovative technology enables healthcare professionals and their patients to facilitate comprehensive personal health monitoring. Breathing well is essential for a good quality of life.

Our Products

The Smart One allows you to measure, monitor and track lung function no matter your location. Perfect for monitoring asthma, COPD, lung transplant care, cystic fibrosis, and other conditions.

Spirobank Smart

The Spirobank Smart is a personal-use spirometer that produces professional-level results. It is like having a portable PFT lab in your pocket!

All-in-one Spirometer with 7-inch Touchscreen, embedded printer and Oximetry (optional).

Spirobank II Smart

A versatile, clinical-grade spirometer complete with Oximetry (optional). Connect via Bluetooth with Tablet (iOS and Android) and PC (Windows and MacOS - also supports USB connection).

An easy-to-use, full function spirometer with minimal maintenance necessary.

Capable of performing spirometry, 6 min walk test, sleep study, and 24-hr oximetry.

Spirobank II Basic

Provides essential spirometry parameters, ideal for basic spirometry screening (e.g., General Practice, Occupational Medicine and Urgent Care).

FlowMIR™ Disposable Turbine

Compatible with all MIR professional spirometers for single-patient use. Factory calibrated and not affected by temperature, humidity or barometric pressure.

VBMax-FlowMIR Disposable Turbine

Compatible with all MIR professional spirometers for single-patient use. Includes viral/bacterial filter mouthpiece.

Reusable Turbine Flowmeter

Compatible with all MIR professional spirometers for multi-patient use. Requires cleaning and disinfection between patients.

Single Patient Reusable Turbine

Compatible with all MIR personal spirometers with a 1-year life span. No calibration needed.

MIR Spiro (Windows/Mac)

Complete and powerful desktop software solution for clinical Spirometry and Oximetry testing and results management.

MIR Spiro App (iOS/Android)

Allows Healthcare Professionals to connect the Spirobank II Smart to a tablet for portability and maximum ease-of-use.

MIR Spirobank App

Mobile App (iOS and Android), for real time at home spirometry and oximetry testing, directly on your Smartphone via Bluetooth Smart 4.0

Smart One App

Mobile App (iOS and Android), for real time spirometry and oximetry test, directly on your Smartphone/Tablet via Bluetooth Smart 4.0

Wellness Begins with a Breath

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Quick Guide: MIR WinSpiroPRO

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• Spirometers
• Medical International Research, Inc.

Spirolab Spirometer W/Bluetooth - Sp02 Optional- In Stock

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Product Description

Medical international research/spirolab spirometer.

Documentation:

Fast and intuitive for modern professionals. Each function can be activated by a simple touch on the intuitive bar menu always present on the screen.

Suitable for children. Patented pediatric incentive directly on the screen to improve patient compliance during a Spirometry test.

• All in One Portable Desktop Spirometer
• FVC, FEV1, IVC, MVV, PRE/POST Bronchodilator comparison with a wide range of selectable parameters
• Long Life Rechargeable Battery
• Color Touchscreen 7 inch Display
• Direct Connection to External USB Printer
• Stores 10,000 Spirometry Tests
• Wireless Real Time Test on PC via Bluetooth
• Fast and Silent ted Printer with Customizable Printout Format
• New WinspiroPRO
• High performance PC software for spirometry 
• Includes Carrying Case

Technical Specifications

• Power Supply: Rechargeable Battery and Mains Power
• Temperature Sensor: Semiconductor (0-45°C)
• Flow Sensor: Bi-directional Digital Turbine
• Flow Range: ±16L/s
• Volume Accuracy: ±3% or 50mL
• Flow Accuracy: ±5% or 200mL/s
• Dynamic Resistance:
• Connectivity: USB 2.0, Bluetooth 2.1
• Display: 7 inch Color Touch Screen LCD, 800 x 480 resolution
• Mouthpieces: Ø 30 mm (1.18 inch)
• Dimensions: 220 x 210 x 51 mm (8-5/8 x 8-1/4 x 2 in)
• Weight: 1450g (3.1 lbs.) - Battery pack included
• Spirometry Parameters: FVC, FEV1, FEV1/FVC, FEV1/VC, PEF, FEF25, FEF50, FEF75, FEF25–75, FEF75–85, Lung Age, Extrapolated Volume, FET, Time to PEF, FEV0.5, FEV0.5/FVC, FEV0.75, FEV0.75/FVC, FEV2, FEV2/FVC, FEV3, FEV3/FVC, FEV6, FEV1/ FEV6, FEV1/PEF, FEV1/ FEV0.5, FIVC, FIV1, FIV1/FIVC, PIF, FIF25, FIF50, FIF75, FEF50/FIF50, VC, IVC, IC, ERV, IRV, Rf, VE, VT, tI, tE, VT/tI, tE/tTOT, MVV (measured), MVV (calculated).

MIR Turbine Flowmeters (comply with ATS/ERS standards)

Spirometry testing requires maximum accuracy and hygiene. FlowMir is the answer to both requirements. Each turbine is factory calibrated with a computerized system and it is packaged individually in a clean room. 100% hygiene guaranteed! Option available: reusable turbine.

What's Included?

• Spirolab spirometer ( Sp02 is optional )
• Adult Sp02 probe if optional Sp02 is ordered
• Bluetooth Included: 1 WinspiroPRO CD
• Miniflowmeter with cable
• Power supply/battery charger
• 1 roll of thermal paper
• 1 nose clip
• 1 carrying case 

Product Videos

Custom field, product reviews, write a review.

Medical Int'l Research

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• Medical International Research Manuals
• Medical Equipment

Medical International Research Spirolab Manuals

Medical International Research Spirolab User Manual (36 pages)

Table of contents.

• Table of Contents 2

1 Introduction

• User Type 4
• Ability and Experience Required 4
• Where the Device Is Used 4
• Individual Patient Factors that Can Affect Use of the Product 4
• Limitations of Use - Contraindications 4
• Risk of Cross Contamination 5
• Mouthpiece 6
• Sensor for Oximetry 6
• CE Mark for Medical Devices 8
• Electrical Safety Symbol 8
• USB Port Warning Label 8
• Spo2 Oximetry Port Warning Label 8
• WEEE Label 8
• Label Relating to the Method for Charging the Battery Pack 8
• FCC Certification Label 8
• Electrostatic Discharge Symbol 9
• Information on Protection against Ingress of Liquids 9
• Symbol for Devices that Include RF Transmitters 9
• Symbol for Reading the Operating Instructions 10
• Product Description 10
• Spirometer Specifications 11
• Oximeter Specifications 12
• Other Features 13

2 Using the Spirolab

• Turning the Spirolab on and off 13
• Saving Energy 14
• Main Screen 14
• Symbols and Icons 15
• Calibrating Turbines 17
• Entering New Patient Data 19
• Editing Patient Data 20
• How to Search the Archives 20
• Viewing Archived Data 20
• Displaying the Last Test Session 21
• Online Mode (Connected to a PC) 21
• FVC Test 22
• MVV Test 23
• Running POST Tests after the Administration of a Drug 23
• Interpreting Spirometry Results 24
• Instructions for Using the Sensor on Individual Adult Patients 27

3 Data Transmission

• Data Transmission Via Bluetooth 28
• Connecting with a PC Via USB Port 28
• Printing Data 29
• Up-Dating Internal Software 29

4 Maintenance

• Checking Correct Turbine Function 30
• Cleaning the Oximetry Sensor 30
• Replacing Wrap Sensor Adhesive Tape 30
• Recharging the Battery Pack 30

5 Trouble Shooting and Solutions

• Guarantee Conditions 34

Appendix 3 Information about the Correct Use of Device in an Electromagnetic Environment

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• News & Trends
• Medical Technical Facilities
• Healthcare IT, Telemedicine
• Hospital software
• MIR - Medical International Research

Exhibitions

Medical software winspiropro® spirometry hospital analysis.

Characteristics

Description.

Meet this supplier at the following exhibition(s):

11-14 Apr 2024 Shanghai (China) Hall vide - Stand vide

11-14 Nov 2024 Düsseldorf (Germany)

Other MIR - Medical International Research products

• Analysis software
• Viewer software
• Windows software
• Reporting software
• Scheduling software
• Monitoring software
• Diagnostic software
• Measurement software
• Test software
• Printing software
• Communication software
• AI software
• Telehealth software
• Clinical iOS application
• Tablet PC iOS application
• ISO software
• Telemonitoring software
• Lung software
• MacOS software

The Peritoneal Dialysis Transfer Set Replacement Procedure

Affiliations.

• 1 Former Center Manager, Satellite Healthcare, San Jose, CA.
• 2 Director of Clinical Programs and Research, Satellite Healthcare, San Jose, CA.
• 3 Past President of ANNA.
• 4 member of the Nephrology Nursing Journal Editorial Board.
• 5 member of ANNA's Central Missouri Chapter.
• 6 Senior Research Director, Satellite Healthcare, San Jose, CA.
• 7 Adjunct Clinical Assistant Professor, Division of Nephrology, Department of Medicine, Stanford University School of Medicine Stanford University, Palo Alto, CA.
• 8 Senior Medical Director, Satellite Healthcare, San Jose, CA. and Division of Nephrology, Department of Medicine, Stanford University School of Medicine Stanford University, Palo Alto, CA.
• 9 Vice President of Home Services, Satellite Healthcare, San Jose, CA.
• 10 Director of Research, Satellite Healthcare, San Jose, CA; an Honorary Professor of Nursing, Faculty of Health, Deakin University. Melbourne, Australia.
• 11 International Member of ANNA.
• 12 Chief Medical Officer, Satellite Healthcare, San Jose, CA; and an Adjunct Lecturer, Division of Nephrology, Department of Medicine, Stanford University School of Medicine Stanford University, Palo Alto, CA.
• PMID: 32830940

Peritoneal dialysis transfer sets (extension lines) are replaced every six to nine months to minimize peritoneal dialysis catheter complications. The aim of this study was to compare a revised non-bag transfer set exchange procedure with the standard bag exchange procedure on nursing time, costs, and safety. Thirty-three people were randomized to two groups - a standard bag exchange procedure group (n = 16) and a non-bag transfer set exchange procedure group (n = 17). The standard bag exchange procedure took a median of 32 minutes (interquartile range [IQR] 25 to 38 minutes) compared to the non-bag transfer set exchange procedure of 6 minutes (IQR 4 to 8 minutes) (p Ò 0.0001). There was one episode of peritonitis in each group within the 72-hour follow-up period. The average cost of the non-bag transfer set exchange procedure was $24.54 lower, a 37% cost reduction. This study has shown the revised non-bag transfer set replacement procedure appears to be safe, consume less participant and staff time, and decreases costs.

Keywords: end stage kidney disease; home dialysis; nephrology nursing; peritoneal dialysis; transfer set.

Copyright© by the American Nephrology Nurses Association.

Publication types

• Randomized Controlled Trial
• Catheterization / adverse effects
• Costs and Cost Analysis
• Nursing Evaluation Research
• Peritoneal Dialysis / adverse effects
• Peritoneal Dialysis / economics
• Peritoneal Dialysis / methods*
• Peritoneal Dialysis / nursing*
• Peritonitis / etiology
• Peritonitis / prevention & control
• Treatment Outcome
• Workload / statistics & numerical data

• Clinical Studies

We are a medical device company based in Santa Clara, CA, dedicated to helping people with heart failure feel better and live longer.

Ancora Heart is dedicated to providing new treatment options for patients suffering from heart failure. Our team has a deep appreciation for the challenges faced by the estimated 26 million patients across the globe who are living with this chronic, progressive disease. Despite advances in heart failure treatment, high rehospitalization and mortality rates persist. Patients suffer from debilitating symptoms, exercise intolerance, poor quality of life, frequent hospitalization, and reduced life expectancy. In fact, up to 50 percent of people who develop heart failure die within five years of diagnosis. It is clear that patients need new options to treat symptoms and improve their quality of life, and we are committed to developing new solutions that help change the course of this challenging condition.

To address this challenge, we developed the AccuCinch ® Ventricular Restoration System, the only completely transcatheter device designed to treat the enlarged left ventricle, restore structure and function and bring relief to heart failure patients who remain symptomatic despite current guideline-directed medical care. The AccuCinch System procedure is minimally invasive and is designed to augment the existing care cardiologists provide their heart failure patients.

For patients who have heart failure with reduced ejection fraction (HFrEF, or pumping efficiency), in whom the disease has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch System may provide a new treatment option by filling the gap between medication or pacemaker therapy and more invasive treatments, including left ventricular assist devices (LVADs) or heart transplant.

The AccuCinch System has been studied in multiple clinical trials in the United States and the European Union, and is currently enrolling patients in the CORCINCH-HF Study, a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation, which is designed to enroll 400 patients at up to 80 centers worldwide.

The study has a unique design allowing initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached 12 months of follow-up. (ClinicalTrials.gov Identifier: NCT04331769 )

MEET OUR TEAM

PRESIDENT AND CEO

Jeffrey m. closs.

Mr. Closs brings proven leadership in medical devices, health policy, and technology to the Ancora Heart team. He has dedicated his career to working at the intersections of change to promote innovative, life-changing solutions. He has extensive experience founding new ventures (Benu), driving a successful IPO (Perclose), and having leadership roles at Fortune 500 companies (Fox Hollow, Edwards, Guidant, Bentley). Formerly a director at Nellix Endovascular, which was acquired by Endologix, and BioIQ, a health tech company, he is also an adjunct professor at Stanford University Center for Health Policy and the former president of the St. Raymond School Board. Mr. Closs holds an MBA from Emory University and a BA from the University of California, Los Angeles.

CHIEF TECHNICAL OFFICER

Russel sampson.

A champion for the development of minimally invasive surgical systems, Mr. Sampson brings a proven track record of invention (over 80 U.S. international patents) to his position at Ancora Heart. Leveraging his deep experience with CE and PMA approvals, commercialization, profitability and acquisition for companies such as Cytyc, Novacept, Abbott Laboratories, Space Systems/Loral and Ford Aerospace, he is responsible for our core technology, intellectual property and product development efforts. Mr. Sampson is the co-founder of Sierra Surgical Technologies (SST) and holds a BS in Mechanical Engineering (AMES) from the University of California, San Diego.

CHIEF COMMERCIAL OFFICER

Mr. Miles brings 25 years of experience scaling medical technology companies to his position as chief commercial officer (CCO) of Ancora Heart, including his most recent post as CCO of Terumo Aortic in Glasgow, Scotland. In that role, he was responsible for global sales and marketing, custom solutions, portfolio strategy and expansion into new markets, helping guide the company during a period of significant growth. Prior to his time at Terumo Aortic, Mr. Miles served as senior director of commercial strategy at Invuity, where he played a key role in driving adoption of their core product lines across key surgical specialties throughout the United States. He was instrumental in facilitating significant growth through the company’s eventual IPO in 2015. Previously, Mr. Miles held positions of increasing responsibility at Medtronic, serving as director of global marketing of the Endovascular Business Unit. He began his career at Eli Lilly and Company, serving various commercial leadership roles during his eight-year tenure. Mr. Miles received an MBA from Pepperdine University and a BS in health sciences from James Madison University.

VICE PRESIDENT OF BIOSTATISTICS AND CLINICAL DATA MANAGEMENT

Christine tjossem.

Ms. Tjossem brings a 35-year track record of successful growth and leadership in biostatistics and data management to her position at Ancora Heart. Her experience includes key roles establishing and managing biostatistical and data management efforts at some of the world’s leading clinical research and medical device organizations, including Medtronic, Boston Scientific, St. Jude and Berlin Heart. Ms. Tjossem began her career working in medical research for Mayo Clinic in Rochester, Minnesota. As Vice President of Biostatistics and Data Management, Ms. Tjossem is responsible for all facets of her team’s success in advising and implementing appropriate techniques and methods for statistical and data management areas. In addition to managing these line-of-business functions, Ms. Tjossem’s vast breadth and depth of experience allows her to make significant contributions to the company’s overall business, regulatory and clinical strategy. Christine received her Bachelor of Science degree in Statistics from Iowa State University.

VICE PRESIDENT AND GM, INT’L CLINICAL, REGULATORY AND THERAPY DEVELOPMENT

Michael zapien.

Drawing on his expertise in transitioning innovative medical devices from the developmental stage to commercial success at several emerging startups (Elixir, Nanostim), Mr. Zapien leads our clinical research. Previously the Director of Clinical and Medical Affairs at CardioDx, Inc., he also has clinical and commercial experience at Medi-Globe, Silk Road Medical, Abbott Vascular, and Guidant Corp. Mr. Zapien is a certified clinical researcher with a MS from the University of Maryland and a BS from San Francisco State University.

VICE PRESIDENT OF STRATEGIC INITIATIVES

Bart beasley.

A veteran of introducing early-stage and ground-breaking therapies to physicians, Mr. Beasley brings over 25 years of experience in healthcare marketing to Ancora Heart. By building partnerships with the clinical community, gathering first-hand insights towards procedure and product development, and enhancing clinical trial patient education and recruitment, he has helped drive the rapid growth of multiple revolutionary therapies and new therapeutic categories. Mr. Beasley served as Vice President of Marketing at Avinger, drove market development at Transcend Medical (acquired by Alcon), was Director of Marketing at Fox Hollow (acquired by ev3), and began his career at Perclose (acquired by Abbott). Mr. Beasley holds an MBA from IESE Business School in Barcelona, Spain and a BS in Economics from Santa Clara University.

VICE PRESIDENT OF REGULATORY AFFAIRS AND QUALITY ASSURANCE

Michael fritz.

Mr. Fritz comes to Ancora Heart with decades of medical device industry experience including strategic leadership, management, operational, and hands-on roles in regulatory affairs, clinical research, quality assurance, and engineering. His career includes roles with small start-ups (Synapse Biomedical and Cyberkinetics) and larger companies (Medtronic, Boston Scientific, and Guidant) developing class III implantable devices and class II minimally invasive devices in diverse fields including interventional cardiology, cardiac electrophysiology, neurology, pulmonary/respiratory, laparoscopic surgery, neurosurgery, rehabilitation medicine, and neuroprosthetics. Mr. Fritz holds an MS degree in software engineering from the University of St. Thomas and a bachelor of electrical engineering degree from the University of Minnesota.

Meet Our Board of Directors

Robert croce, andrew midler, beverly huss, jeffrey closs.

Bob Croce culminated 12 years as Company Group Chairman through a 36-year career at Johnson & Johnson. Beginning in 1968, Mr. Croce held a series of senior positions beginning as a Sales Representative for Ortho Pharmaceuticals where he was later named Vice President of Marketing. Prior to that, he served as Worldwide Franchise Chairman of Cordis and Ethicon Endo-Surgery. In 1985, Mr. Croce was named Vice President of Business Development at McNeil. He was later transferred to Ethicon, Inc., where he served as Group Vice President, and was later named President in 1990. In 1992, he was promoted to Worldwide President of Ethicon Endo-Surgery.

SAVITR CAPITAL

Savitr Capital was founded by Andrew Midler in 2008. Prior to Savitr Capital, Andrew founded Standard Pacific Capital in 1995. The investment management firm launched with $75 million of assets and grew to over $5 billion. Until 2005, Midler managed the firm’s Global Long/Short Equity Fund for Standard Pacific’s flagship product. He also supervised the firm’s credit opportunities, commodity, quantitative, and Japan long/short equity strategies. He served as the CIO and CEO of the firm from 1995 to 2007 before selling his majority ownership interest in the firm in December 2007. Prior to founding Standard Pacific, Midler was the Director of Equity Portfolio Management at CS First Boston, a global institutional money management firm. Previously, he managed a significant portion of the global hedge fund, Odyssey Partners. From 1986 through 1993, he worked at Fidelity Investments where he was Portfolio Manager of the Fidelity Convertible Securities Fund, Fidelity Equity Income II Fund and Fidelity Growth & Income Fund.

LCP VENTURES

Lew Pell is one of the most prolific and successful medical technology investors. Since 1975, Pell has been the lead investor and co-founder of 24 different medical device manufacturers, eight of which have been sold for a collective net gain of $1.6 billion. Pell’s founding of medical technology companies began in 1975, when he and Katsumi Oneda co-founded Machida America to sell flexible endoscopes. In 1979, he created Pentax Precision Instruments and sold it to Asahi Optical eleven years later. Over a span of 15 years, Pell co-founded various medical device companies including: American Endoscopy (acquired by Medtronic), Heart Technology (acquired by Boston Scientific), InStent (acquired by Medtronic), and Vision Sciences. He was also co-founder of Biosense (acquired by Johnson & Johnson), Influence, Inc. (acquired by American Medical Systems), and Disc-O-Tech (sold to Kyphon).

MADORRA, INC.

Beverly Huss is a medical device entrepreneur, board director and mentor who brings with her more than 20 years’ experience as a leader of both large corporations and start-up companies in the medical device space. She is currently Executive Chair of Madorra, Inc., a women’s health company focused on improving quality of life after menopause. Ms. Huss was co-founder and CEO of Pagonia Medical. Prior to founding Pagonia, she was president and CEO of Qool Therapeutics, Inc., a tissue preservation company. Previously she was co-founder and CEO of Vibrynt, Inc., a company that developed a novel minimally invasive therapeutic device for treatment of morbid obesity. Prior to this, Ms. Huss was with Santa Clara, California-based Guidant since 1986, fulfilling a variety of executive roles within the company’s various medical device divisions. She managed the worldwide Endovascular Solutions business as President and quadrupled worldwide revenues to $150 million for the carotid and peripheral vascular business in four years. In addition, she built Guidant’s coronary stent business to $1B with 90% gross margins.

PRESIDENT & CEO

Work with us.

It has come to our attention that an unknown entity is impersonating our organization and extending illegitimate job offers via email, purportedly in an attempt to defraud intended applicants.

Please be advised that these email solicitations appear to be part of a fake job scheme. For additional information, please see https://www.fbi.gov/contact-us/field-offices/elpaso/news/press-releases/fbi-warns-cyber-criminals-are-using-fake-job-listings-to-target-applicants-personally-identifiable-information .

Authorized Ancora Heart employees will reach out to potential candidates directly via telephone or email from ancoraheart.com but will never issue questionnaires or request personal information.  Job offers will only be extended after a thorough interview process and multiple interactions with Ancora Heart staff members.  When communicating, please be very cautious of fictitious email addresses.

Ancora Heart is looking for talented professionals to join our growing team. We value creativity, drive, accountability, and the ability to work collaboratively with one another. If you thrive in a fast-paced setting and are passionate about changing the way heart failure is treated, consider the following opportunities:

Clinical Research Associate (Device Accountability)

PURPOSE OF POSITION :

Support the Clinical Affairs team to ensure investigational device accountability such that the clinical trial is operating in accordance with the clinical protocol(s); Federal Regulations 21CFR821; any other applicable policies, regulations, procedures, and/or guidelines to ensure data integrity and Trial Master Files are maintained. Support the Clinical Operations team to ensure integrity of clinical and/or compliance data.

MAJOR DUTIES AND RESPONSIBILITIES:

• Verify, in conjunction with the Operations team, quantities, lot numbers, and expiration dates of outgoing shipments.
• Verify data in outgoing shipment manifests to include specific details regarding packing lists, device accountability log information, addresses, site specific information (i.e., contact name and number).
• In a timely manner, confirm receipt of product at the site and ensure the completion and collection of manifest documentation.
• Troubleshoot and resolve any issues that arise during transit, delivery and receipt of shipments.
• In conjunction with Site Management and Field Operations, ensure the completion of site training for the receipt and handling of investigative product.
• With Therapy Development and Field Operations teams, review and reconcile post-implant devices.
• Collect and review Device Use Forms and Device Accountability Logs prior to return shipments.
• Coordinate and expedite device returns including creation of FedEx labels.  Ensure complete and accurate documentation.
• With the Operations staff, ensure the accuracy of return shipments, restocking, and tracking of devices.
• With Operations and Clinical Operations staff, create and maintain a system for the accurate tracking of devices returned and dispositioned (i.e., restocked, disposed, or recommissioned.)
• With Operations and Clinical Field Operations staff, fully review, reconcile, and file all documentation related to device accountability.
• Order, track and manage Clinical Trial materials.
• Manage in-house filing of critical materials.
• As needed, complete projects and tasks as assigned by the Clinical Affairs team.
• Work with Site Management to generate information and distribute EU and US study newsletters.
• Review, assess, create and update clinical quality and monitoring SOPs, monitoring plans, and other clinical affairs forms.
• Prepare Essential Document Tracker Status report as needed.  Perform comprehensive eTMF audits.
• Work with Field and Clinical Operations teams to maintain accurate study documents.
• Complete projects and tasks in an aggressive manner consistent with corporate objectives. Keep supervisor informed of changes in work schedule and/or workload.
• Regularly recognize problems and recommend and implement methods of conduct of clinical study.
• Perform other duties as assigned.
• Support company goals and objectives, policies and procedures, and compliance with Ancora Heart SOPs, Good Clinical Practices, Good Manufacturing Practices and FDA regulations.  Ensure compliance with Quality System Regulations and ISO 9001, EN 46001, and MDD requirements.

EDUCATION REQUIREMENTS :

• BS preferred in Life Sciences, Medicine, or other technical discipline.

EXPERIENCE REQUIREMENTS :

• Minimum five years related experience in health-related field in addition to working knowledge of FDA regulatory requirements.       

OTHER QUALIFICATIONS :

• Must possess excellent written and verbal communication skills.
• Able to travel and work in the Santa Clara Office
• Must be willing and able to travel to work related meetings and seminars, as needed.
• May require the ability to deliver speeches and/or presentations effectively to a variety of audiences.

Clinical Safety Associate

PURPOSE OF JOB :

The Clinical Safety Associate assists the Safety Manager and is responsible for the oversight of the adverse events and product experiences reported within a clinical trial as directed by the Safety Manager. The Clinical Safety Associate assists with ensuring the appropriate reporting of the events to the necessary internal departments and applicable Authorities throughout the life of the trial.

The Clinical Safety Associate assists the Safety Manager who acts as a liaison between the internal departments as well as to external customers such as CROs, Clinical Events Committees and Data Safety Monitoring Boards associated to the trial.

MAJOR DUTIES AND RESPONSIBILITIES :

• Participate in the formulation of case report forms, specifically with regards to reporting and management of adverse events.
• Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other report documents as needed to support regulatory filings to US and International regulatory bodies.
• Review clinical safety databases for adverse events and device deficiencies and compose safety narrative reports.
• Assist sites with subject evaluation and protocol adherence for adverse event reporting timelines.
• Assist managing Clinical Events Committee (CEC), Data and Safety Monitoring Board (DSMB) and Safety outsource activities.
• Collaborate with team to resolve complex or unclear situations.
• Maintain a professional and credible image with clinical investigators, hospital staff and other customers, FDA, Notified Bodies, and other regulatory bodies, consultants, vendors, and co-workers.
• Maintain current knowledge of applicable clinical literature.
• Attend relevant meetings as appropriate.
• Support company goals and objectives, policies and procedures, and compliance with Good Clinical Practices and FDA regulations.
• Keep manager informed of changes in work schedule/and or workload.

Registered Nurse (Associate degree); Bachelor’s degree in a Scientific discipline, Life Sciences, Medicine, or other technical discipline.

• Experience of at least 5 years in the medical industry in addition to at least 2 years of Safety monitoring experience.
• Experience in conducting clinical trials.
• Clinical knowledge and understanding in medical record and medical diagnostic report review.
• Excellent internal and external customer service skills
• Excellent written and verbal communication skills
• Detail oriented and ability to problem solve
• Able to make evaluative judgements
• Able to work independently and in a team environment
• Able to develop and deliver presentations to a variety of audiences
• Able to provide technical advice, guidance, and support to others in your area of expertise

Manufacturing and Process Engineers

• Support the company’s transition from clinical stage to commercialization within manufacturing, process, and automation engineering. Evaluate and optimize existing processes, design & implement custom fixtures, tooling, automated equipment within and outside a cleanroom environment.  Work closely with the R&D, Operations, and Quality Systems staffs to improve existing processes and perform process validations.  This hands-on role requires accountability and the ability to work with minimal supervision.
• Design, document, assemble, and qualify production assembly / test / inspection fixtures and equipment.
• Specify, procure and implement off the shelf automated and semi-automated equipment
• Design, develop and implement custom equipment as-needed.
• Create verification or validation protocols, execute studies and/or tests, and author and release subject reports.
• Perform characterization studies and Design of Experiments (DoE).
• Author and perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
• Write and maintain manufacturing documentation including material and component specifications, work instructions, BOMs, routers, Process FMEAs, DMR, protocols, reports, and DHF documents.
• Maintain compliance with Ancora Heart’s quality systems including all applicable SOPs, non-conforming materials disposition, corrective action investigations and closure, and Engineering Change Order (ECO).
• Train operators on new processes, tools, and equipment.
• Work as the liaison among R&D, Operations, and Quality Systems to ensure a smooth transition of design changes, tooling, and fixturing.
• Assure product and process quality by designing testing methods; testing sub-assemblies, finished product and process capabilities.
• Develop, qualify and implement processes to improve manufacturability.
• Complete projects and tasks in a timely manner consistent with corporate objectives. Keep manager informed of changes in work schedule and/or workload.
• Maintain compliance to QSR systems in coordination with the Document Control and Quality Assurance functions.
• Support company goals and objectives, policies and procedures.
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New review provides insights into the impact of osteoporosis and related medications on fracture healing

by International Osteoporosis Foundation

A new comprehensive review, authored by the International Osteoporosis Foundation (IOF) Committee of Scientific Advisors Fracture Working Group on behalf of the IOF and the International Society of Orthopaedic Surgery and Traumatology (SICOT), clarifies the evidence linking fracture healing with osteoporosis and the currently available medications used to treat osteoporosis.

Within clearly outlined chapters, " Impact of osteoporosis and osteoporosis medications on fracture healing. A narrative review " examines the biology of fracture healing , clinical and radiological evaluation of fracture healing, the impact of osteoporosis on fracture healing, the effect of osteoporosis medications on fracture healing, and important areas for further research. The findings are published in the journal Osteoporosis International .

Professor Manju Chandran, first author of the publication, stated, "A recent fracture significantly increases the likelihood of another fracture. Prompt osteoporosis treatment is imperative to reduce this risk. Concerns however linger among medical and surgical professionals about the potential adverse effects of osteoporosis medications on fracture healing.

"Furthermore, when patients undergoing osteoporosis treatment sustain fractures, clinicians may ask themselves whether to halt osteoporosis therapy during the healing process. Our review delves into the available evidence to provide some clarity and practical guidance that will be useful for the many clinicians and surgeons caring for patients with fragility fractures."

The following key points are highlighted:

• The assessment of fracture healing typically should involve a combination of clinical examination and radiographic imaging.
• While animal studies appear to support the view that osteoporosis negatively influences fracture healing, clinical studies in humans have yielded conflicting results.
• The effect of osteoporosis medications on fracture healing has been extensively studied, though most of the investigations have been in animal models and therefore may not fully translate to humans.
• Overall, there does not appear to be a negative effect of osteoporosis medications on fracture healing. Bisphosphonates can be safely started early after metaphyseal osteoporotic fractures without adversely affecting clinical outcomes.
• There is a suggestion of benefit for teriparatide in time to fracture healing. Data on the impact romosozumab on fracture healing is scant.
• Other factors such as aging, smoking, poor nutrition, and comorbidities such as diabetes and vitamin D deficiency may confound and contribute to delayed healing of osteoporotic fragility fractures.
• The benefit of treating osteoporosis and the urgent necessity to mitigate imminent fracture risk should take precedence over any theoretical risks of non-union or delayed union.
• More research is needed: new radiological and biological markers of fracture healing must be identified and clinical and basic science methodologies to assess fracture healing should be merged for greater understanding. Data on the impact of antiosteoporosis agents such as teriparatide, romosozumab on fracture healing deserve further attention.

Professor Nicholas Harvey, co-author and Chair of the IOF Committee of Scientific Advisors concluded, "Fortunately there appears to be no deleterious effect of osteoporosis medications on fracture healing. The evidence does not support a delay in the initiation of antiresorptive therapy following acute fragility fractures, nor is there reason for suspension of osteoporosis medication at the time of fracture if the person is already on treatment."

"Given the serious and potentially life-threatening consequences of secondary fractures, the benefit of treating osteoporosis and the urgent necessity to reduce imminent refracture risk after a fracture should be given prime consideration."

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Anthropology

Anthropology doctoral student ebenezer adeyemi was awarded a t. anne cleary international dissertation research fellowship from the ui graduate college.

Anthropology doctoral student Ebenezer Adeyemi was awarded a T. Anne Cleary International Dissertation Research Fellowship from the UI Graduate College. Ebenezer’s research interests center around medical anthropology, infrastructure, the intersection of urban landscape and public health, African studies, and survival strategies in marginalized urban communities. For his ongoing doctoral research, Ebenezer is exploring strategies that residents of Makoko, a large informal settlement in Lagos State, Nigeria, use to access healthcare to treat malaria, the most prominent health issue in their community.   

NOTICE: The University of Iowa Center for Advancement is an operational name for the State University of Iowa Foundation, an independent, Iowa nonprofit corporation organized as a 501(c)(3) tax-exempt, publicly supported charitable entity working to advance the University of Iowa. Please review its full disclosure statement.

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April 8, 2024

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Fluorous lipopeptides act as highly effective antibiotics for multidrug-resistant pathogens

Multidrug-resistant bacterial infections that cannot be treated by any known antibiotics pose a serious global threat. Publishing in the journal Angewandte Chemie International Edition , a Chinese research team has now introduced a method for the development of novel antibiotics to fight resistant pathogens. The drugs are based on protein building blocks with fluorous lipid chains.

Antibiotics are often prescribed far too readily. In many countries they are distributed without prescriptions and administered in factory farming: prophylactically to prevent infections and enhance performance. As a result, resistance is on the rise—increasingly against reserve antibiotics as well. The development of innovative alternatives is essential.

It is possible to learn some lessons from the microbes themselves. Lipoproteins, small protein molecules with fatty acid chains , are widely used by bacteria in their battles against microbial competitors. A number of lipoproteins have already been approved for use as drugs.

The common factors among the active lipoproteins include a positive charge and an amphiphilic structure, meaning they have segments that repel fat and others that repel water. This allows them to bind to bacterial membranes and pierce through them to the interior.

The team led by Yiyun Cheng at East China Normal University in Shanghai aims to amplify this effect by replacing hydrogen atoms in the lipid chain with fluorine atoms. These make the lipid chain simultaneously water-repellant (hydrophobic) and fat-repellant (lipophobic). Their particularly low surface energy strengthens their binding to cell membranes while their lipophobicity disrupts the cohesion of the membrane.

The team synthesized a spectrum (substance library) of fluorous lipopeptides from fluorinated hydrocarbons and peptide chains. To link the two pieces, they used the amino acid cysteine, which binds them together via a disulfide bridge.

The researchers screened the molecules by testing their activity against methicillin-resistant Staphylococcus aureus (MRSA), a widespread, highly dangerous strain of bacteria that is resistant to nearly all antibiotics. The most effective compound they found was "R6F," a fluorous lipopeptide made of six arginine units and a lipid chain made of eight carbon and 13 fluorine atoms. To increase biocompatibility, the R6F was enclosed within phospholipid nanoparticles.

In mouse models, R6F nanoparticles were shown to be very effective against sepsis and chronic wound infections by MRSA. No toxic side effects were observed.

The nanoparticles seem to attack the bacteria in several ways: they inhibit the synthesis of important cell-wall components, promoting collapse of the walls; they also pierce the cell membrane and destabilize it; disrupt the respiratory chain and metabolism; and increase oxidative stress while simultaneously disrupting the antioxidant defense system of the bacteria.

In combination, these effects kill the bacteria—other bacteria as well as MRSA. No resistance appears to develop.

These insights provide starting points for the development of highly efficient fluorous peptide drugs to treat multi-drug resistant bacteria.

Journal information: Angewandte Chemie International Edition

Provided by Wiley

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