• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Medtronic trumpets 12-year heart valve study | Research roundup

Medtronic trumpets 12-year heart valve study | Research roundup

February 28, 2011 By MassDevice staff

Clinical trials roundup

After 12 years, Medtronic Inc.’s (NYSE:MDT) Mosaic bioprosthetic heart valves are still working, according to a study published online in The Journal of Thoracic and Cardiovascular Surgery.

The Minneapolis-based medical device giant touted the study that evaluated the performance of its Mosaic valve in patients who had aortic valve replacement (AVR) and mitral valve replacement (MVR).

The Mosaic valve is an artificial heart valve designed to replace a diseased or damaged heart valve, usually the aortic or mitral valve. The device was approved by the U.S. Food and Drug Administration in 2000.

"With 12 years of follow-up, the study revealed a freedom from structural valve deterioration of 93.3 percent of AVR patients 60 years and older and in 95.3 percent of MVR patients 70 years and older. In addition, hemodynamic performance data showed stability up to 10 years, indicating durability of the Mosaic bioprosthesis over time," the company said.

Here’s a roundup of recent clinical trial and scientific study news:

  • Kuros treats first patient with its dural sealant product candidate
    Kuros Biosurgery AG treated the first patient in a pilot clinical trial investigating the safety and efficacy of KUR-023, its novel dural sealant product candidate. KUR-023 is a synthetic hydrogel-based sealant that utilises Kuros’ synthetic technology. The product candidate is administered as a spray with the aim of ensuring water-tight closure of incisions or tears through the dura mater. It is intended to be used as an adjunct to normal closure techniques such as suturing. The trial is a European, single arm, multi-center, study that will recruit 40 patients. The primary endpoint refers to the prevention of intraoperative leakage with secondary endpoints related to safety and further efficacy assessment. KUR-023 is delivered from a double barrelled syringe with a mixing spray tip. The product candidate is delivered as a spray which then arrives on the dura as a liquid, conforms to the surface, and quickly polymerises.
    Read more
  • Caliper’s Phase I EPA ToxCast data makes the pages of Toxicology
    Caliper Life Sciences, Inc. (NSDQ:CALP) announced that the results of its initial screening efforts under the U.S. Environmental Protection Agency’s ToxCast program have been published in the scientific journal Toxicology. Key findings reported include a high level of quality and reproducibility in the dataset allowing for robust statistical analyses, and the role that specific targets in biological pathways could play in toxicity events. These findings underscore the success of the Phase I ToxCast effort and support continued expansion of the program to build predictive models for identifying chemicals with high risk for human toxicity or environmental hazard. Caliper has recently been awarded three new task orders with an aggregate value of $3.1 million to fund additional activities under the EPA ToxCast program.
    Read more
  • OrbusNeich touts Genous stent study
    OrbusNeich announced that 12-month follow-up data from the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) registry published in the February issue of EuroIntervention demonstrated good clinical outcomes with low incidence of repeat revascularization and stent thrombosis (ST) for the company’s Genous Stent. Target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization (TVR), was 8.4 percent at 12 months. The composite of death, MI or target lesion revascularization (TLR) occurred in 7.9 percent of the patients. TLR and ST were 5.7 percent and 1.1 percent, respectively.
    Read more
  • Biomoda completes patient enrollment for pilot study
    NewCardio Inc., (OTC:NWCI) announced that the Company has been invited by the Heart Rhythm Society (HRS) to present results of a recent clinical study showing that recurrent atrial fibrillation (AF) was accurately and timely detected in patients who used CardioBip for daily monitoring following catheter ablation procedures. The presentation, entitled "Long-term Intermittent Wireless Remote Monitoring of Reconstructed 12-Lead ECG in Post-Ablation AF Patients Using the CardioBip System", will be made at the 32nd Annual Scientific Sessions of the HRS, to be held in San Francisco, May 4-7.
    Read more
  • Study: In IVF cycles, endometrium dramatically improves after G-CSF treatment
    During in vitro fertilization (IVF) cycles, treatment with a medication called granulocyte-colony stimulating factor (G-CSF) significantly improves inadequate endometrium (lining of the uterus), according to a report published electronically on February 15 in Fertility and Sterility – the official journal of the American Society for Reproductive Medicine (ASRM). The reported case series also suggests that G-CSF treatment may, in general, improve IVF pregnancy chances. G-CSF is a cytokine (protein molecules that facilitate communication between cells) that has already been FDA approved for other clinical indications. Researchers from New York City-based Center for Human Reproduction (CHR) and a second NY fertility center reported on four women with highly inadequate endometrium, unresponsive to conventional treatments and facing IVF cycle cancellation. In all four cases, endometrial perfusion of G-CSF expanded the endometrium to a minimal thickness of 7mm within approximately 48 hours, allowing for embryo transfer. Surprisingly, all four patients also conceived.
    Read more

Filed Under: News Well Tagged With: Caliper Life Sciences Inc., Clinical Trials, NewCardio Inc.

In case you missed it

  • Google Health hires FDA’s chief digital health officer
  • ApiJect picks up $111M investment from Royalty Pharma, Jefferies
  • Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
  • Teleflex wins Health Canada nod for Manta vascular closure device
  • Study shows strong performance, improved outcomes with Medtronic Evolut TAVR
  • New FDA clearance expands indications for Xact Robotics’ ablation system
  • Medtronic’s Resolute Onyx drug-eluting stent demonstrates strong safety, efficacy
  • Avanos Medical recall of Cortrak 2 enteral access system is Class I
  • Jabil launches Qfinity reusable auto-injector
  • Launching your med device: A strategy & execution cross-functional guide
  • FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11
  • FDA clears DePuy Synthes’ Inhance for total shoulder arthroplasty
  • Henry Schein hires former Medline veteran to drive ‘One Distribution’ push
  • FDA authorizes Labcorp’s non-prescription COVID-19 test that also detects flu, RSV
  • Massachusetts is competing for ARPA-H biomedical research center
  • Vivasure raises $23M initial Series D tranche; could reach up to $54M
  • Exactech announces breakthrough nod for JointMedica’s hip resurfacing system

RSS From Medical Design & Outsourcing

  • Google Health hires FDA’s chief digital health officer
    Former FDA Chief Digital Health Officer of Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency. Patel became senior director, global digital health strategy and regulatory for Google Health earlier this month, he said on LinkedIn. Patel recounted highlights of his “incredible journey since… […]
  • Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
    Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body. What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection,… […]
  • FDA moves forward with Voluntary Improvement Program to bolster medical device quality
    Kathryn Burke, Emergo Group The U.S. Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device manufacturing following promising results of a pilot program. The FDA guidance stems from a pilot undertaken by the agency along with the Medical Device Innovation Consortium (MDIC) in 2018.… […]
  • How Minnetronix Medical helped Lazurite with its wireless surgical camera
    Minnetronix Medical (St. Paul, Minnesota) has played an important development and manufacturing partner role with Lazurite’s wireless surgical camera system. It’s been nearly two months since Lazurite (formerly Indago) announced FDA 510(k) clearance of its ArthroFree system. ArthroFree combines proprietary low-heat, high-intensity Meridiem light engine technology with advanced camera, battery and wireless transmission technologies and… […]
  • Instron releases TrendTracker data analysis workflow platform
    Instron announced that it released the TrendTracker module in Bluehill Central for accelerating data analysis workflows. Norwood, Massachusetts-based Instron designed TrendTracker with an intuitive interface to improve the data analysis workflow of single or multi-location materials testing laboratories. According to a news release, the platform features quick searching and the ability to display and analyze… […]
  • Henry Schein hires former Medline veteran to drive ‘One Distribution’ push
    Henry Schein (Nasdaq:HSIC) today named Dirk Benson as VP and chief commercial officer of the medical device manufacturer and distributor’s North America Distribution Group (NADG). Melville, New York-based Henry Schein is the world’s largest provider of health care supplies and services for office-based dental and medical practitioners, and NADG is the company’s largest business group. The… […]
  • The road to a robot: Medtronic’s development process for its Hugo RAS system
    Elephants are the perfect analogy for surgical robotics, Medtronic (NYSE:MDT) VP of Marketing for Surgical Robotics Mike Stow says. Speaking on the “Road to a robot: Designing technology to address unmet needs & barriers” panel at DeviceTalks Boston last week, Stow explained that elephants are big, taking up a lot of space and that they eat a lot, making… […]
  • iRhythm stays silent on federal grand jury subpoenas
    More than one year after receiving the first of two federal grand jury subpoenas seeking information about its products and communications with the FDA, iRhythm Technologies has said little publicly about the matter. It would have been easy to miss the San Francisco-based cardiac monitor maker’s initial disclosure last summer. iRhythm (Nasdaq:IRTC) was without a… […]
  • How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
    A lot of talk around Dexcom (Nasdaq:DXCM) in the last couple of years has centered around its next-generation G7 continuous glucose monitor. The latest iteration of the company’s CGM platform has already garnered CE mark this year and awaits FDA approval, with some expectations for that to come after the American Diabetes Association’s Scientific Sessions next month. The company also presented… […]
  • Texas power grid struggles in heat one year after record cold stopped semiconductor plants
    A heatwave in Texas took at least six power plants offline Friday, with high temperatures forecasted to blaze throughout this week. A record cold snap in February 2021 took NXP Semiconductors and Samsung chip fabrication facilities offline for weeks, contributing to a global semicondcutor shortage that is still throttling medical device production. There’s no indication… […]
  • How Stryker includes users for product design in the digital age
    Medical device developers and manufacturers like Stryker (NYSE:SYK) are changing how they approach design as digital technology becomes more crucial. Four Stryker executives shared how the Kalamazoo, Michigan–based orthopedic device giant is thinking differently about medical product development and how health care providers and patients will ultimately use them. The DeviceTalks Boston panel of Stryker… […]

Leave a Reply

You must be logged in to post a comment.

Primary Sidebar

DeviceTalks Weekly

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS