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Baroreceptor Stimulation

Phase 1

Hypertension | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Oct 30, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01458483Acute Carotid Sinus Endovascular Stimulation II StudyPHASE1 COMPLETED 9Oct 1, 2011Oct 1, 2012Oct 30, 20121 United States
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Study Endpoints
Primary Endpoints
Change in systolic blood pressure during electrical stimulation
Intraoperative testing only
Change in diastolic blood pressure during electrical stimulation
Intraoperative testing only
Secondary Endpoints
Characterize number and type of side effects seen during stimulation
Intraoperative testing only
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Baroreceptor StimulationEXPERIMENTAL -
Interventions
NameTypeDescription
Baroreceptor StimulationDEVICEThe stimulation catheter may be placed in different locations within the IJV at the level of the cervical spine vertebrae. Stimulation amplitudes will be varied from 0.1 mA to 20 mA.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject is at least 18 years old * Subject is hypertensive (defined as at least one in-office Systolic BP measurement ≥140 mm Hg or Diastolic BP ≥90 mm Hg within three months prior to enrollment * Subject is undergoing a cardiac catheterization involving right heart catheteriz...

Countries:United States
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