DGAP-News: Gerresheimer AG / Key word(s): Market launch/Regulatory Approval
27.09.2018 / 11:02
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Micro pump for Parkinson’s treatment from Gerresheimer subsidiary Sensile Medical receives European CE declaration of conformity
Duesseldorf/Olten, September 27, 2018 – A wearable micro pump from Sensile Medical has received EU certification for the European market. A European pharma company has obtained a CE declaration of conformity for the pump, which is specially designed for the treatment of Parkinson’s disease, and is now bringing it to market. This is the first time a micro pump from Gerresheimer subsidiary Sensile Medical has come into commercial use.
The micro pump is used in the treatment of advanced Parkinson’s disease. Its great benefit for patients relates to ease of use, including features such as automatic filling with liquid medicine. State-of-the-art technologies such as a color display, charging unit and data storage help enhance therapy management. The handy-sized, discreet pump comes with a leather bag for it to be worn on the user’s belt.
A prerequisite for market launch was the CE declaration of conformity for medical devices. Now it has that, the pharma company can bring the pump to market. Sensile Medical developed the micro pump for Parkinson’s disease treatment especially for the pharma company concerned. It is one of currently five concrete customer projects in various therapeutic areas.
“The CE declaration of conformity and market launch for the first micro pump, in this case for Parkinson’s treatment, marks a key milestone for our subsidiary Sensile Medical. The deservedly strict approval standards for patient-critical delivery systems of this kind are now satisfied and market launch can begin. We are correspondingly optimistic regarding further application areas for Sensile Medical’s micro pump technology,” explained Andreas Schütte, Member of the Management Board of Gerresheimer AG.
A personally programmable basal profile enables treatment to be optimized for Parkinson’s patients and ensures that they receive the precise dosage they need. Likewise for the bolus rate: A patient can cause the device to deliver a bolus at just one touch of a button. Sensile Medical’s patented SenseCore micro rotary piston pump at the heart of the pump device ensures exceptionally safe, precise drug delivery. An even greater level of safety is attained by eliminating flow rate calculations.
“In developing the micro pump for Parkinson’s treatment, we have completed a highly ambitious project to exacting requirements that improves treatment for patients. The device also comes with a large number of different languages already on board, enabling its use in many countries around the world,” explained Derek Brandt, CEO of Sensile Medical AG.
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