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Dot Medical selects Arrow Medical as manufacturing partner
Dot Medical of Macclesfield has formed a manufacturing partnership with Arrow Medical Ltd of Kington to build the Alert System for treatment of atrial fibrillation, one of the most common cardiac conditions experienced by the over 50’s. The Alert system uses a catheter to deliver precisely controlled, low intensity electrical shocks to the heart as part of the treatment to restore normal rhythm.
Dot Medical Ltd acquired the Alert System from EP MedSystems Inc in 2008 to extend the European and international market for the Alert device which offers a very safe and effective catheter-based system of internal cardioversion by delivering very low intensity electrical shocks directly to the heart through the catheter to restore normal heart sinus rhythms. This technique avoids many of the risks associated with high energy external shocks, powerful direct current stimulation, long-term anti-arrhythmic therapy and pharmacological cardioversion treatments.
Manufacturing these complex products requires considerable investment in processes, systems and technology“ commented Rita Didcock, Managing director of Arrow Medical. “While our business has over 20 years experience of contract medical manufacturing and is well accustomed to clinical excellence in clean room ‘life-critical’ medical production to ISO 13485, the Alert also requires a number of carefully controlled and delicate manufacturing operations to assure very high levels of electrical, electronic and mechanical integrity. Here we are working with advanced materials in critical high precision assemblies with platinum for the electrodes, radio-opaque polyurethane and inflatable high integrity materials. As part of this project Arrow Medical invested heavily in additional specialist training for all our production and support staff to meet Dot Medical’s stringent standards.”
The Alert catheter assembly is a complex multi-purpose balloon tipped design incorporating two primary multipoint electrode arrays for delivery of cardioversion shocks while a separate single electrode provides ventricular pacing and sensing functions. It also has the facility to draw blood and infuse drugs depending on the cardiac surgeon’s requirements to treat the patient.
The Alert's catheter assembly will be produced at Kington in Arrow Medical's new Class 10,000 clean room production facility for Class 3 medical devices and Arrow Medical will be supporting Dot Medical with a full range of services including assembly, sterilisation and product validation, packing, stock control and global secure distribution. All components of the Alert System have passed the quality requirements for continued long term high volume production at Kington and Dot Medical has now received full European certification and CE Marking in conformity with Directive 93/42/EEC. All production at Arrow Medical Kington meets the stringent international quality standards of ISO 13485:2003, FDA and GMP.
For more product and service information, contact Rita Didcock at Arrow Medical Ltd on +44 (0)1544 231760 or email rita@arrowmedical.co.uk
More media information from Ewart Woolley at CMPR see www.cmprnews.co.uk
Page update 15.15 GMT 17th August 2009
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