Humanitarian Device Exemption (HDE) Approval
The BAROSTIM NEO ® LEGACY System has received Humanitarian Device Exemption (HDE) status from the Food and Drug Administration (FDA). This means that in the United States The BAROSTIM NEO® LEGACY System is a Humanitarian Use Device (HUD), or, “a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year".1
Patients who qualify to receive a BAROSTIM NEO ® LEGACY System must meet all of the following criteria:
- Have resistant hypertension
- Have had bilateral implantation of the Rheos® Carotid Sinus Leads Models 1010R, 1010L, 1014L, and 1014R (which have been discontinued and are obsolete)
- Have been identified as responders in the Rheos® pivotal clinical study
- If a patient meets the above criteria, the device is considered as approved by FDA.
Use of the Carotid Sinus Lead Repair Kit is contraindicated in patients with infection at or near the implant pocket region.
Federal law restricts this device to sale by or on the order of a physician.
Humanitarian Device. Authorized by Federal law for use in the treatment of resistant hypertensive patients implanted with the Rheos CSL leads. The effectiveness of this device has not been demonstrated.
For more information on Humanitarian Device Exemption, please see here.
For more information on the BAROSTIM NEO ® LEGACY System as a Humanitarian Device Exemption, including labeling and complete safety information, please see here.