Carmeda AB is a Sweden-based company in the field of hemocompatible coatings for medical devices. The CARMEDA® BioActive Surface is available for licensing.
The CARMEDA BioActive Surface (also known as CBAS Heparin Surface) is a clinically proven hemocompatible coating designed to actively reduce thrombus formation on blood-contacting medical devices. The technology utilises the well-established anticoagulant activity of heparin, which is covalently bound to the surface via end-point attachment. This bonding technology preserves the functional activity of heparin, which is not the case for commercially available heparin coatings in general.
The CARMEDA BioActive Surface actively suppresses the coagulation mechanism and provides a lasting thromboresistance, which will reduce or eliminate thrombotic complications related to the exposure of blood to artificial materials. The CARMEDA BioActive Surface also minimises activation of the innate immune system, which will decrease the inflammatory response and reduce complications driven by inflammation.
Carmeda AB has extensive experience in bringing their coating technology on new medical devices through regulatory approval and on to the market. The company is a streamlined, project-driven organization, which ensures a smooth process for both feasibility studies and product development as well as for manufacturing. The company's regulatory affairs professionals will support the entire process and provide documentation of the technology, and regulatory expertise for both new products and approved applications featuring the CARMEDA BioActive Surface. Carmeda AB always strives to meet the customers' expectations and deliver on time.
Carmeda AB has state-of-the-art cGMP-compliant facilities and offers contract coating for customers. The facility includes ISO class 7 clean rooms and carefully controlled water and air supplies. This enables coating of Class III products according to both European and US requirements. The manufacturing infrastructure is flexible and new medical devices can easily be integrated into the existing environment. The quality management system meets the requirements of both the FDA's Quality System Regulation 21 CFR Part 820 and ISO 13485.
Carmeda AB invented the patented end-point heparin bonding technology and has a long history of pioneering research in this field since the company was founded in 1984. Already back in 1986 the first patient benefitted from a medical device coated with the CARMEDA BioActive Surface. Today, numerous devices featuring this coating technology are approved for marketing and sales worldwide. An impressive track record of scientific papers, including clinical studies, have demonstrated the safety, efficacy and superiority of the CARMEDA BioActive Surface. To learn more about the technology, find scientific references and see examples of approved products, please visit the Carmeda website. Would your company's medical device benefit from a thromboresistant coating?
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CARMEDA® and CBAS are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.