The launch of the Vercise primary cell (PC) and Vercise Gevia deep brain stimulation (DBS) systems, featuring the Vercise Cartesia Directional Lead (Boston Scientific) has been announced. The new systems, which were recently approved by the US Food and Drug Administration (FDA), feature technology designed to allow physicians to control the range, shape, position and direction of electrical stimulation to treat the symptoms of Parkinson’s disease (PD) through personalised therapy. The Vercise Cartesia Directional Lead was the first directional lead introduced to the global market when it launched in Europe in 2015.
The new systems leverage eight individually controlled electrodes on each lead to offer stimulation that can adapt to impedance changes within the brain. This level of precise stimulation to the neural target is critical for avoiding unwanted side effects and obtaining optimal DBS outcomes.
The Vercise Gevia DBS System is a rechargeable system with a battery life of at least 15 years and the non-rechargeable Vercise PC DBS System, which offers the same stimulation capability, has a projected battery longevity of at least three years with typical settings. The new systems are supported by programming software with STIMVIEW™ technology, enabling a physician to visualize how the stimulation used in DBS therapy will be distributed in the brain.
The first Boston Scientific Vercise System in the USA was approved by the FDA in December 2017. Clinical evidence of the effectiveness of the Vercise portfolio includes the INTREPID study, the first multicentre, prospective, double-blind, randomised sham-controlled study of DBS for PD in the USA. Data from the INTREPID study demonstrated that patients treated with the Vercise System had a 49.2% improvement in motor symptoms as measured by clinicians in the Unified Parkinson’s Disease Rating Scale (UPDRS) III scores at one year follow-up (n=152).
The Vercise Directional DBS Systems are currently being utilised in several clinical studies including the global DBS post-market registry and DIRECT-DBS, which is designed to evaluate programming effectiveness of directional leads for the treatment of Parkinson’s disease.