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Gerresheimer’s Sensile Medical wins CE Mark for infusion pump

September 27, 2018 By Fink Densford

Gerresheimer's Sensile Medical

Gerresheimer subsidiary Sensile Medical said today it won CE Mark approval in the European Union for its wearable micropump intended for use in the treatment of Parkinson’s disease.

The newly cleared device features automatic filling for use with liquid medicines, and includes a color display, charging unit and leather bag which allows the device to be worn on the owner’s belt.

“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,” Gerresheimer management board member Andreas Schütte said in a prepared statement.

The micro pump from Sensile Medical also features a programmable basal profile intended to optimize treatment for Parkinson’s patients, and the ability to deliver a bolus with the press of a button.

“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,” Sensile Medical CEO Derek Brandt said in a press release.

Gerresheimer touted the clearance as the first for its Sensile Medical subsidiary, which it acquired in July in a deal worth as much as $409 million.

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance Tagged With: gerresheimer, sensilemedical

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