Acusure®

The Acusure® range of coatings is designed to improve both the biocompatibility and durability of orthopaedic and certain other implantable medical devices. Clinical studies undertaken by both Accentus Medical and its customers have proved the safety and efficacy of Acusure® coatings and several of the coatings in this range have been in continuous clinical usage for more than twelve years(1)(2)(3). Devices incorporating Acusure® have been used in all regions of the world including Europe, the USA and Japan, and an estimated one hundred thousand patients are benefiting from Acusure® coated implants.

  • Acusure®
    Technology
  • How
    Acusure® Works
  • Acusure®
    Process
  • Manufacturing
    and Regulatory

Acusure® Technology

Accentus Medical has developed and commercialised the Acusure® range, which includes a series of advanced coatings that are applied using proprietary inert/reducing gas, thermal plasma spraying techniques to orthopaedic implants manufactured by medical device companies around the world. The Acusure® range includes medically pure titanium, titanium alloy, cobalt chrome alloy and hydroxyapatite.

How Acusure® Works

Applied to implant surfaces, Acusure® coatings are designed to improve initial implant fixation and to encourage growth of new host bone adjacent to the implant which results in increased long term stability of the device and a better outcome for the patient.

Acusure® Process

Our Acusure® range refers to the inert/reducing gas plasma spray application of coatings, and was developed by Accentus Medical scientists. A key driver in the development of Acusure® was to find a replacement for the traditional expensive and time-consuming vacuum plasma spraying techniques, while producing coatings with the level of purity, strength and adhesion required by international medical device regulations.

Accentus Medical has over 30 years of experience in the development, refinement and application of inert/reducing gas plasma spray coatings onto metallic surfaces as this technique was invented by Accentus Medical’s historical parent, the UK Atomic Energy Authority.

Manufacturing and Regulatory

Accentus Medical operates from its expanding facilities at the Harwell Science and Innovation Campus at Harwell, south of Oxford, UK. Acusure® coatings are applied using one of two purpose-built inert/reducing gas plasma spray machines.

Both machines have been subjected to full process validation studies as required by regulatory authorities in Europe and North America.

Acusure® coatings comply with all applicable ASTM, ISO and BS standards as well as with the US Food and Drug Administration (FDA) guidelines on metal / hydroxyapatite coatings(4)(5).

Accentus Medical has been awarded ISO-13485 accreditation by its notified body, Lloyds Quality Register (LRQA). The company has also been fully audited by the US FDA and has been awarded an FDA licence no 3005913274 as a manufacturer of medical devices. The company has also taken the initiative to lodge a masterfile related to Acusure® coatings with the FDA. This file MAF-1961 can be utilised and referred to by any customer submitting relevant devices for marketing approval in the USA.

Contact Us

T: +44 (0)1235 434 320
F: +44 (0)1235 434 329
E: enquiries@accentus-medical.com

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