Pacemaker Line Approved
The Sorin Group received marketing clearance from the Food and Drug Administration for their new line of dual and single chamber pacemakers, the REPLY family. The new devices are the smallest pacemakers available, according to the European based company.
The dual chamber pacemaker available from the company is small, at just 8 ccs. The system is the company’s next evolution in pacing systems to promote the normal, natural functioning of the heart and reduce the requirement for ventricular pacing.
The REPLY tools incorporate the SafeR pacing mode from the company. This technology was developed from the company’s AAISafeR pacing mode that was originally launched in Europe in 2003.
The AAISafeR system is able to switch from AAI to DDD when AV block is detected. This capability is shown to reduce pacing that is not necessary for patients with Sinus Node Disease and unselected AV Block patients. Unnecessary right ventricular pacing can increase patient risk of developing atrial fibrillation or heart failure.
The REPLY pacemakers also incorporate a number of automated features. One of those is SmartCheck, a system that allows users to automate requests for follow-up tests and provides extensive reporting of data and other requirements.
The Sorin Group specializes in the development of medical technologies for cardiac surgeries. The company also creates tools used to treat chronic kidney disease.
August 11, 2008 Related topics: Product Approval & Certification, Cardiology