ARROW MEDICAL BUILDS CATHETER-BASED SYSTEM TO TREAT ATRIAL FIBRILLATION
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.
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