Dot Medical selects Arrow Medical

Dot Medical selects Arrow Medical as manufacturing partner

Dot Medical Ltd of Macclesfield, Cheshire UK has formed a manufacturing partnership with Arrow Medical Ltd of Kington, Herefordshire UK 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.

Arrow Medical was founded in 1989 by a group of medical device entrepreneurs who recognised the growing need for outsourcing of manufacturing of medical devices and equipment. Today the business employs more than 60 staff and manufactures a wide range of medical devices used in anaesthesia, orthopaedics, cardiology, inflatable medical products, and fluid and air management carried out in dedicated clean rooms. Major production technologies include specialist medical fabric engineering, cutting and sewing, sealing and bonding, radio frequency welding, electronic and mechanical assembly, injection and compression moulding for silicone and organic elastomers and other medical plastics. Production is also supported by automatic gluing, heat welding and sophisticated inspection services. Arrow Medical is a major exporter and meets the standards of FDA GMP and ISO 13485. In the last two years Arrow Medical has invested in duplex clean rooms and investment in clean room moulding, associated radio frequency (RF) welding facilities and in-line sterile packaging services is currently under way.

For more information about Arrow Medical Ltd contact
Rita Didcock
Arrow Medical Limited
Hatton Gardens Industrial Estate
Kington
Herefordshire
HR5 3RB

Mobile +44(0)7748 325175
Tel: +44(0)1544 231760
Fax: +44(0)1544 231640

Email: rita@arrowmedical.co.uk
Web: www.arrowmedical.co.uk

For more information about Dot Medical Ltd contact
Ian Rankin
3 Bailey Court
Macclesfield,
Cheshire UK
SK10 1JQ
Email: info@dot-medical.com
Web:www.dot-medical.com

Patient information at www.internalcardioversion.com
Tel: +44 (0) 1625 668811
Fax: +44 (0) 1625668855

For more media information contact
Ewart Woolley
CMPR
The Mews,
Brook Street,
Mitcheldean,
Gloucestershire GL17 0SL

Tel: +44 (0)1594 516079
Mobile: 07790 865162
Web: www.cmpr.co.uk
Newsweb: www.cmprnews.co.uk
Email: ewart@cmpr.co.uk
Page update 28/01/10