• 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
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates
Home » Silicone Materials for Long-term Medical Implants: Innovate for the Future

Silicone Materials for Long-term Medical Implants: Innovate for the Future

June 4, 2019 By Sponsored Content

medical implants

By Feifei Lin, Ph.D., Business Development Manager, Healthcare, Elkem Silicones USA Corp.

With the growth of the aging population, the number of age-related diseases has increased. Every year millions of patients sustained or improved their lives through surgical procedures involving implanted devices. Medical implants such as orthopedics, pacemakers, cardiovascular stents, defibrillators, neural prosthetics or combinational devices like drug-eluting stents have become an indispensable part of modern medicine.

Long-term implantable devices used to improve and sustain life are highly regulated by regulatory bodies around the world to ensure safety and efficacy. Raw materials supplied to medical implants are subjected to the qualification of the devices makers.

Silicone elastomer advantages

Primarily due to the stability of the Si-O-Si bond, silicone elastomers are more suitable for medical implants than carbon-based plastics and rubber in many aspects:

  • Unsurpassed biocompatibility and hypoallergenic
  • Chemically inert, resistant to oil, solvent and stain
  • Bacterial resistant, easy to clean and sterilize
  • Long shelf life, maintain performance and integrity under harsh conditions, such as -80C to 300C
  • Dielectric with superior insulating properties

Because silicone elastomers have these superior characteristics, silicones have been used in long-term implants for decades. The first published report of silicone elastomer for long term implantation was in 1946 by Dr. Franklin H Lahey, for bile duct repair[1].  By the late 1960s, the medical-grade silicone elastomer had found its way into many long-term implants such as joint arthroplasty, catheters, drains, and hydrocephalus shunts. For over half a century, silicone elastomers have proven to be a safe material that enables millions of patients to overcome debilitating conditions.

Today, as the market demands more efficient and effective care, long-term implantable devices are undergoing dramatic transformations due to advancement in the tech industry. The implants are becoming valuable biomedical control units for monitoring and responding on demand via wireless communication. Devices are getting smaller and are being integrated into electronics which require higher material performance to meet the requirements for integrity and durability; the integration of devices with Internet of Things (IOT) requires lower temperature fabrication.

With the future in mind, Elkem Silicones offers full lines of high-performance Silbione® Biomedical LSRs Silbione® Biomedical HCRs for LTI and drug delivery to meet the challenges of the industry. These offerings are based on the platinum-addition cure system and offer a full range of low to high durometer, higher physical properties, lot-to-lot consistency, and easy mold release.

Elkem Silicones has made significant investment in our manufacturing facility, quality system, and regulatory support to ensure we meet or exceed the standard for long-term implantable materials. Our state-of-the-art manufacturing site in York, SC is ISO 9001 certified with a certified ISO class 8 manufacturing environment and an ISO class 7 packaging environment. Material attestations, toxicology summaries, biocompatibility, MAF and DMF, are available upon request. Our on-staff toxicologists are available to provide regulatory support for these materials.

Elkem Silicones is advancing a robust innovation portfolio, covering high-performance silicone materials and process technologies that enable the future medical devices. In the upcoming MDM Minneapolis, Elkem Silicones will be launching a long term implantable grade, high performance, one-part, tin-free, ambient cure adhesive. This adhesive can bond to different surfaces such as silicone elastomers, polyurethane, polyester, aluminum, and titanium, etc. It offers significant productivity improvement and simplification in the manufacturing process because of fast cure without the need for heating and humidity. It is the first tin-free long-term implantable silicone adhesive in the market.

We have successfully demonstrated 3D printing with our LSRs, which not only enables rapid prototyping but also introduces the possibility of enhancing device physical properties through design. Unlike conventional injection molding, 3D printing LSRs makes it possible to print hollow scaffolds to increase elasticity, strength and decrease weight per part. Recently, Elkem Silicones launched the next generation LSR (liquid silicone rubber), LSR SELECT™, a patented, advanced system of LSR materials and dosing capabilities. This proven system gives you CONTROL to optimize your cure kinetics improving productivity and flexibility to achieve your precise results. In addition to controlling your cure profile, now you can create a repeatable, unique durometer blend. With this technology it is possible to over mold onto temperature sensitive components such as sensors or substrates, meeting the challenges of manufacture combinational drug delivery devices with heat sensitive active pharmaceutical ingredients.

Elkem is proud to be part of the long-term implantable material suppliers. Not only do we offer these materials, but also innovative solutions, expertise, and services to device makers, designers and fabricators. Together with our customers, we advance current and future implants to save people and better human lives.

Visit Elkem Silicones website for more product information. (https://silicones.elkem.com/EN/Our_offer/Market_And_Application/Pages/Long-term-medical-implants.aspx)

Contact Feifei.lin@elkem.com for further questions

LINKS:

LSR: https://resources.silicones.elkem.com/asset/29:elkemsiliconeslsrltilinecardna2018
HCR: https://resources.silicones.elkem.com/asset/28:elkemsiliconeshcrltilinecardnajune2018

[1] Biomaterial Science, An introduction to Materials in Medicine, by ELSEVIER ACADEMIC PRESS, 2nd edition, Chapter 7.19, p. 698, “Medical Application of Silicones”, Andre Colas and Jim Curtis

Sponsored content by Elkem Silicones

Filed Under: Sponsored Content Tagged With: elkemsilicones

In case you missed it

  • BD touts study of antigen test over molecular test for identifying infectious people
  • Titan Medical closes on $11.5M offering
  • GE ticks up on mixed-bag Q4
  • BD CEO Polen to also serve as board chair
  • Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants  
  • Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral
  • Longeviti Neuro Solutions ClearFit implant wins FDA clearance for use in ultrasound
  • Medical Alley startups raise $1.4B
  • Johnson & Johnson pharma sales drive Street-beating Q4 results
  • Abbott Panbio rapid antigen test wins CE mark for asymptomatic COVID-19 screening
  • Orthospin wins FDA clearance for robotic external fixation system
  • 3M ticks up on Street-beating Q4, strong healthcare performance
  • Butterfly Network names new CEO before going public via merger
  • Authorities investigating death of California recipient of COVID-19 vaccine
  • FDA clears Aerobiotix system to clean air inside hospitals
  • Inogen names new CEO
  • FDA clears Theranica device for adolescent migraines

RSS From Medical Design & Outsourcing

  • Freudenberg Medical expands U.S. molding operations
    Freudenberg Medical announced that it has expanded injection molding operations at its Baldwin Park, Calif., operation, which is focused on thermoplastics. Freudenberg Medical Baldwin Park has added six injection molding machines including three new Arburg molding machines, a work cell for two-shot molding and a Wittmann Battenfeld micro-molding machine with in-process visual inspection capability. The… […]
  • Cretex Companies names new CEO
    Cretex Companies has announced the retirement of CEO Lynn Schuler effective January 31, 2021. Schuler will be succeeded as CEO by company president and COO Jeff Wollerman. Schuler has been with Cretex Companies for 36 years and held numerous leadership positions, including six years as a business unit president and two years as CFO. Schuler… […]
  • How continuous glucose monitors have transformed the diabetes landscape
    Continuous glucose monitors (CGMs) are among the most potent diabetes management tools to emerge in recent decades. FDA approved the first professional CGM in 1999, and the technology has evolved swiftly since then. Current models beam data via Bluetooth to smartphones (plus the Apple Watch) and the cloud, enabling patients to explore their blood glucose… […]
  • FDA clears Theranica device for adolescent migraines
    Theranica announced today that the FDA has granted expanded clearance for the use of its Nerivio acute migraine treatment device by people 12 years and older. The use of the device in the treatment of adolescents is supported by a study recently published in Headache. According to the study, 28 of 39 (71%) of the… […]
  • Alleviant Medical wins FDA breakthrough device designation for transcath heart failure treatment
    Alleviant Medical (Austin, Texas) has received FDA breakthrough device designation for its no-implant, interatrial shunt technology for treating certain types of chronic heart failure. Founded in 2017, Alleviant’s minimally invasive transcatheter tech decompresses the left atrium without a permanent cardiac implant or open-heart surgery. Alleviant developed the teach to treat people who have heart failure […]
  • AdvaMed wants input on Biden pandemic DPA use
    AdvaMed reacted to President Joe Biden’s plan to use the Defense Production Act (DPA) to tackle the pandemic with some cautionary words. In a letter responding to Biden’s 200-page COVID-19 plan, the medtech trade group asked for collaboration and urged the president to consider the industry’s experience with DPA orders issued by former President Trump.… […]
  • January 2021 Issue: The Leadership in Medical Technology Issue
    9 lessons in crisis management from Stryker CEO Kevin Lobo These 10 stories mattered the most for medtech in 2020 How ResMed is advancing sleep and respiratory care How Dexcom CEO Kevin Sayer is leading the company forward Black engineers group works to promote diversity in medtech, equity in healthcare Taking the guesswork out of… […]
  • Olympus recalls thousands of endo devices due to packaging defect
    Olympus is recalling approximately 26,000 disposable EndoTherapy devices because of a packaging defect that could compromise their sterility. The announcement affects113 models distributed in the U.S.since early 2019, with different numbers of SKUs available in different regions worldwide. The company is asking customers to quarantine the devices until they can be shipped back to Olympus.… […]
  • FDA says to limit mask decontamination to 4 cycles
    Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times. The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major… […]
  • 5 innovations to make duodenoscopes more single-use — and save lives
    Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past. Luckily, several medical device companies have stepped in to solve the problems. Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat and stomach into the top of the small intestine.… […]
  • Plastic Molding Manufacturing adds 5 molding machines
    Plastic Molding Manufacturing (Hudson, Mass.) announced that it has added five new injection molding and two coordinate measuring machines in upgrades to its manufacturing and quality operations. The $1 million-plus investment will enable the custom molding company to distribute the pair of 214-ton machines, two 259-ton machines, and a 101-ton machine throughout its manufacturing network,… […]

Primary Sidebar

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.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · 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