The Acusure® range of surface coatings are designed to improve both biocompatibility and durability of orthopaedic and certain other implantable medical devices. The Acusure® range includes a series of thermal plasma sprayed Hydroxyapatite, Titanium and Cobalt Chrome metallic coatings (or combinations thereof) that have been in worldwide clinical usage for more than 20 years.
Our Acusure® process uses inert/reducing gas thermal plasma spray coating, developed to offer an alternative to the more expensive and time-consuming vacuum plasma spraying approach, while producing coatings with the level of purity, strength and adhesion required by international medical device regulations.
Clinical studies by our customers continue to demonstrate the safety and efficacy of Acusure® coatings, with several of the coatings having been in continuous clinical usage for more than 20 years(1)(2)(3). Devices incorporating Acusure® have been used in all regions of the world including Europe, North and Latin America, and Asia Pacific regions, and an estimated three hundred thousand patients are benefiting from Acusure® coated implants. Several customer products incorporating Acusure® coatings have achieved independent ratings evidencing successful long-term clinical outcomes(4)(5).
Acusure® coatings are supplied from the company’s facility at the Harwell Campus, using two purpose-built plasma spray booths, that have been subjected to equipment and process validation, as required by international regulatory authorities.
Acusure® coatings comply with all applicable ASTM and ISO requirements as well as US Food and Drug Administration (FDA) guidance on metallic / hydroxyapatite coatings(6)(7).
Accentus Medical’s Quality Management System has been approved to ISO-13485:2016 and we are a registered manufacturer with the US-FDA (3005913274), and have a masterfile (MAF-1691) related to Acusure® coatings. This file MAF-1691 can be utilised and referred to by customers submitting relevant devices for marketing approval in the USA.