Vicor’s PD2i Analyzer™:
Expected to Enable Early Detection of
Autonomic Nervous System Dysfunction

If you’re a physician, you’re well aware that autonomic nervous system (ANS) dysfunction, known as diabetic autonomic neuropathy (DAN) in diabetics, is one of the most widespread and devastating challenges facing medicine today.

If you’re not a neurologist or don’t see many diabetic patients, the idea of testing for ANS dysfunction or DAN may seem beyond the typical scope of your practice. Recent innovations have made objective ANS testing easy and affordable in any practice setting — and annual testing for DAN is recommended for all diabetic patients by the American Diabetes Association.

Further, since DAN is gradual in onset, the disease may be fairly well advanced by the time symptoms are detectable by traditional means. As a result, treatment is often not commenced until the patient is already experiencing vision problems, incontinence, or sexual dysfunction. At this point, nerve damage is well underway, and patients are at significantly increased risk of comorbidities, including cardiac death, stroke, and kidney failure.

Clearly, a diagnostic is needed that can detect DAN long before the onset of nerve damage and comorbidities. Vicor believes its easy-to-use PD2i Analyzer™ is that diagnostic – and physicians using it to test their diabetic patients agree.

A New Approach

After many years of painstaking research, Vicor succeeded in developing the PD2i® nonlinear algorithm, an unprecedentedly powerful means of evaluating heart rate variability and, potentially, the health of the human autonomic nervous system.

Unlike current diagnostics, which are only able to detect the damage DAN leaves in its wake, the PD2i® nonlinear algorithm uses advanced mathematics to directly measure the health of a patient’s ANS. A PD2i® score can be simply and painlessly determined within minutes and may reveal whether a patient has developed DAN, enabling doctors to intervene to protect their diabetic patients from further debilitating disease.

(For a more in-depth explanation of Vicor’s PD2i® nonlinear algorithm, please see the PD2i® Technology and Clinicians Overview pages, or read the underlying research.)

Regulatory Status

Vicor’s PD2i Analyzer™ received FDA 510(k) marketing clearance to measure heart rate variability in early 2009; the use of heart rate variability measure is physician determined. Current procedural terminology (CPT) codes exist that enable physicians using the PD2i Analyzer™ to measure heart rate variability to be reimbursed by insurance carriers, creating a recurring source of revenue from test analysis for Vicor.

A Valuable Addition to Medical Practices

The PD2i Analyzer™ offers numerous advantages over competing diagnostics.  The PD2i Analyzer™:

  • provides better risk-stratification than conventional tests
  • is non-invasive
  • is performed on a resting patient by a nurse or technician
  • uses inexpensive, non-proprietary ECG electrodes
  • provides result in under 20 minutes
  • is easy to use; easy to interpret
  • yields a simple binary result
  • is compact (no treadmill required)
  • is forgiving of data issues plaguing other diagnostics
  • has a low up-front cost and low cost per-test

Learn More About Vicor’s PD2i Analyzer™

To learn more about Vicor’s PD2i Analyzer™ and how you can add it to your practice, contact Vicor at 877.528.PD2i (7324) or refer to our Contact page.