Program Designed to Manage and Accelerate FDA 510(k) and CE Mark Approvals
WAKEFIELD, Mass. – March 25, 2015 – Sciessent, the leading provider of antimicrobial solutions, today announced that activities offered under its Medical Device Market Acceleration Program (MedMAPSM) helped Biovation obtain Class I CE Mark clearance for the new BioArmour™ Blood-Pressure Cuff Shield. Designed specifically for medical-device manufacturers, MedMAP makes the design, development and launch of antimicrobial-treated FDA 510(k) or CE Mark products as seamless and fast as possible.
Leveraging antimicrobials to reduce bacterial colonization and biofilm accumulation on surfaces has been proven to work; yet adding antimicrobial features to medical devices is still viewed as a significant modification by regulatory bodies. This extra layer of complexity has hindered many med-device manufacturers seeking regulatory approvals for these types of products. In response to this challenge, Sciessent created MedMAP to help manufacturers efficiently move antimicrobial-treated products from concept and development to regulatory approval and commercialization.
With MedMAP, Sciessent provides customers with the specialized expertise of its materials scientists, microbiologists and regulatory and marketing professionals. Acting as partners to manufacturers’ development teams, Sciessent has helped many clients successfully file and gain global approvals for medical devices featuring its branded antimicrobial technology. Most recently, Sciessent worked closely with Biovation to obtain Class I CE Mark approval for the company’s antimicrobial-treated BioArmour Blood-Pressure Cuff Shield, a disposable hygienic barrier that attaches to the blood-pressure cuff to prevent hospital-acquired infections.
“When choosing a provider of antimicrobials for our shield, we immediately turned to Sciessent – not only does it have wide-spectrum, high-kill technology, but it also acts as a partner and resource throughout the development, testing and regulatory processes,” said Kerem Durdag, CEO, Biovation. “Right now, there many ‘unknowns’ when it comes to gaining regulatory approvals for antimicrobial-treated devices, and because of that I recommend that med-device manufacturers don’t try to do it alone. Sciessent supported our risk-assessment activities necessary to obtain Class I designation vs. Class III, which significantly simplified the CE Mark approval process.”
“Antimicrobial functionality is a complex, but desired feature for today’s medical devices,” said Lise Moloney, director of business development, healthcare, Sciessent. “With MedMAP, not only is Sciessent providing antimicrobial technology, but also our partnership around design, development, testing, risk assessment and regulatory strategy.”
Sciessent has recently put together an Active Substance Master File that is on file with a Competent Authority in Europe. For med-device manufacturers looking for Class III CE Mark approval, this is a valuable resource that can be accessed and leveraged – significantly saving internal time and resources.
About Sciessent LLC
Sciessent is a leading provider of customized antimicrobial solutions that enhance the value of customers’ products. Agion antimicrobial solutions from Sciessent have been incorporated into a wide range of healthcare, industrial and consumer applications, including medical devices such as central-venous catheters and IV access ports, drinking-water applications like water filters and ice-making equipment, and textiles and apparel. The company’s brands include Agion, Agion Active and Sciessent Lava and are based on naturally occurring elements. Sciessent customers include leading international brands including Vygon, Medegen, Scotsman, Everpure, Follett, Honeywell, UnderArmour, Adidas, Reebok and Skechers.
The Agion® Antimicrobial is presently registered by the United States Environmental Protection Agency as a preservative and bacteriostatic agent for use in treated articles under 40 CFR 152.25a. The information presented herein is not intended to support or endorse public health claims for treated articles. The Agion Antimicrobial is also used in medical devices under the Food and Drug Administration in the US; those medical device claims are based on safety and efficacy testing and are limited to those approved by FDA. In the EU, the Agion Antimicrobial is used in medical devices under the Medical Device Directive: those medical device claims are based on safety and efficacy testing and are limited to those approved by the designated Competent Authorities and/or Notified Bodies.
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