Study overview
Empower BP is a randomized, sham-controlled, double-blinded study enrolling participants in leading centers across the US, Canada, and Europe. Its purpose is to evaluate the safety and effectiveness of the investigational implantable ARC-IM System, which is designed to address symptomatic blood pressure instability in individuals with chronic SCI (>1 year after injury).
Participation in this research study is expected to last approximately 24–28 months. Additional information is available at Onward Medical’s Website.
Is this study right for you?
To take part in this study, participants must:
- Be >1 year post-injury
- Be aged 18–75
- Have a traumatic, chronic spinal cord injury between levels C2–T6 (inclusive)
- Have been diagnosed with sustained hypotension
- Have no history of hypotension prior to injury
- Have an ASIA classification of A, B, C, or D
You may NOT participate in this study if any of the following are true:
- You have a history of heart attack, severe heart rhythm disorder, or stroke in the past six months
- You have kidney or liver disease
- You use a ventilator
- You have an active implanted medical device
- You are pregnant or breastfeeding
- You are unable to receive a spinal MRI
Who to contact for more information
Casey Kandilakis, PT, D.P.T., CCRP, NCS
Email: casey.kandilakis@shepherd.org
