Sensile Medical’s Micro Pump for Parkinson’s Clears EU Marketing Requirement
The medical device was given the European Union’s CE declaration of conformity, a prerequisite for a product to enter the European market.
“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,” Andreas Schütte, member of the management board of Gerresheimer AG, said in a press release.
“We are correspondingly optimistic regarding further application areas for Sensile Medical’s micro pump technology,” he said.
The pump was developed specifically to help patients with advanced Parkinson’s disease to receive their liquid therapies.
This new device takes advantage of Sensile Medical’s patented SenseCore micro rotary piston pump, which is placed at the heart of the pump device and ensures safe and precise medicine delivery. It also comes with an integrated needle that is hidden before and after injection with an automatic insertion-retraction system.
It can be programmed to a specific profile, enabling optimized treatment of Parkinson’s patients by ensuring they receive the precise treatment dosage they are prescribed. By touching a button the patient can make the device deliver a bolus of the therapy, not requiring additional flow rate calculations.
The system uses state-of-the-art technologies, including color display, charging unit, automatic filling, and data storage, which can enhance personalized treatment management. Due to its small size, the pump can be transported in its leather bag that can be worn on the user’s belt.
“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,” said Derek Brandt, CEO of Sensile Medical AG.
This is one of five product projects the company is developing to serve several therapeutic areas.