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Boston Scientific receives CE mark approval for Vercise PC DBS system

Medical equipment manufacturer Boston Scientific has obtained CE mark approval for its Vercise Primary Cell (PC) Deep Brain Stimulation (DBS) system to treat Parkinson's disease (PD).

Vercise

The company has designed the system to deal with the varying needs of patients suffering from PD, primary and secondary dystonia, and essential tremor.

Boston Scientific neuromodulation president and senior vice president Maulik Nanavaty said: "This new system exemplifies the Boston Scientific commitment to advancing DBS therapy and providing impactful and transformative technology to reach a broader range of patients suffering from these debilitating diseases."

The system is a non-rechargeable treatment option, which also supports the Vercise DBS Directional Lead, the commercially available eight-contact segmented lead with current steering.

Vercise platform is claimed to be the only DBS solution that finely controls the size and shape of stimulation with multiple independent current control technology (MICC).

The system comprises unique software solutions with a Clinical Effects Map (CEM), which captures data over time and visually summarizes the progress of individualized patient therapy.

The portfolio is said to be supported by a clinical program, including the ongoing Interpid clinical trial in the US and the Vantage study in Europe. The Vantage study showed significant and consistent improvement in motor scores and improved quality of life.

The Vercise PC DBS system is commercially not marketed in the US, while the rechargeable Vercise DBS System is investigational in the country, which is currently being assessed in the Interpid study.

In August, the firm received approval from the US Food and Drug Administration (FDA) for its Innova Vascular Self-Expanding Stent system to treat patients with narrowing or blockages in the superficial femoral artery (SFA) or proximal popliteal artery (PPA), which will cause a circulatory disorder called peripheral artery disease (PAD).


Image: Vercise Deep Brain Stimulation (DBS) system. Photo: courtesy of Boston Scientific Corporation.