Vercise DBS Clinical Study Data

At Boston Scientific, we back our products with a commitment to the highest standards of clinical evidence. Over the years, we’ve amassed a rich library of clinical data supporting our DBS Directional Systems.* Browse through a selection of our studies on this page.

When do you need directionality?

Despite all the planning, it’s impossible to predict which patients will be the best responders to DBS therapy when they leave the OR. That’s where directionality comes in.

This case report of patients implanted with the Vercise™ PC Directional DBS System demonstrates that even at the less effective ring level, directional current steering compensates by expanding the therapeutic window in which DBS can be effective.¹

Chart showing changes in therapeutic window

Options to enhance your outcomes

An elegant solution to programming directionality, the Vercise Directional Systems next generation programming software allows you to use One Touch buttons and visualize the volume of tissue to be activated with STIMVIEW™ technology. In this case study, optimal symptom relief was achieved using a bipolar configuration, with cathodic current spread evenly over two directional contacts.²

Dysarthria Threshold		2.9 mA	3.6 mA	3.9 mA	> 5.0 mA
Side Effect	Rigidity	Not Resolved	Resolved	Resolved	Resolved
Side Effect	Bradykinesia	Moderate	Moderate	Slight	Minimal

Boston Scientific Directional DBS by the numbers

90% of patients, caregivers and physicians
in a global registry with Boston Scientific’s
Directional Systems reported motor
symptom improvement³

In the DIRECT Study of Boston Scientific Directional
Systems, 11/12 patients were found to have best
programming settings when stimulation was
delivered to a focal contact between individual
contacts on the lead⁴

Why directionality with a single source system isn’t enough

Not all directional leads are the same. When impedances vary, only a directional lead with a Multiple Independent Current Control (MICC) System will maintain the therapy intended to be delivered. This study intends to show how single source directional systems may stimulate off-target structures when faced with varying impedances.⁴

(A) In red is a model for how stimulation would be distributed to two directional contacts for a multiple source current system, for example Vercise™ PC or Vercise Gevia™. In blue is shown the same modeling for a single-source current system. When impedances are stable, both systems deliver therapy similarly. (B1) represents a situation when impedances have changes, for example, an open circuit. Red represents the intended therapy to be delivered, while blue is shown what happens to stimulation on a directional lead with a single-source current system. Notice that current follows the path of least resistance, and can result in stimulation of off-target structures. Figure B2 shows the same situation with a multiple source current system. Notice that in green, a multiple independent current control system does not increase the amount of current flowing to the open current.

Key Resources

References

*	A System that includes the Vercise PC or Vercise Gevia™ IPG and Vercise Cartesia™ Directional Lead(s) form the Vercise Directional System.
1.	Steigerwald et al. (2016). “Directional Deep Brain Stimulation of the Subthalamic Nucleus: A Pilot Study Using a Novel Neurostimulation Device.” Movement Disorders. 8: 1240-1243.
2.	Reker et al. (2016) “Directional Deep Brain Stimulation: A case of avoiding dysarthria with bipolar directional current steering.” Parkinsonism and Related Disorders. 31: 156-158.
3.	Vesper et al. (2018) “Real World Clinical Outcomes Using a Novel Directional Lead from a Multicenter Registry of Deep Bran Stimulation for Parkinson’s Disease.” Presented at ESSFN.
4.	Steigerwald et al. (2018). “DIRECT DBS: A Prospective, Randomized, Multicenter, Double-Blinded Study on Directional DBS – Effects on Therapeutic Window.” Presented at ESSFN.