FDA to support Gondola for Parkinson in the approval process

GONDOLA is a portable medical device for personal use, made for people who live with Parkinson’s Disease able to reduce motor symptoms and to improve balance. The GONDOLA device gives a treatment named “Automated Mechanical Peripheral Stimulation” (AMPS). Several clinical studies have documented that AMPS therapy is effective in improving motor skills in people affected by Parkinson’ symptoms.

The FDA has now included the Gondola device in the Expedited Access Pathway program (EAP). The Expedited Access Pathway (EAP) program is a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases.

Under EAP, the FDA works with device sponsors - in the case of Gondola with the Swiss start-up - to try to reduce the time and cost from development to marketing decision without changing the FDA's approval standard. Components of the program include priority review, more interactive review, senior management involvement, and assignment of a case manager. 

Gondola Medical Technologies SA, the company that manufactures the device, expects to complete all necessary tasks in order to have the final authorization to enter the US market with the device within the next 12 months.

The EU already recognized GONDOLA with the CE certification in 2012. The effectiveness of the device is higher in the intermediate and advanced stages of the disease, when patients have an increasingly less satisfactory response to conventional therapeutic approaches. The therapy delivered by the GONDOLA device is, also, the first to be effective to treat the “Freezing of Gait” symptom, a very annoying and disabling problem that does not respond well to traditional pharmacological treatments.