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Ardian Symplicity Catheter

Phase 1

Hypertension | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Nov 5, 2013

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment73
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00483808Renal Denervation in Patients With Refractory HypertensionPHASE1 COMPLETED 73Jun 1, 2007May 1, 2013Nov 5, 20133 Australia, Poland
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Study Endpoints
Primary Endpoints
To provide confirmation that renal denervation is safe and feasible.
3 years
Secondary Endpoints
Evidence of renal denervation; indication of physiologic response; assessment of device performance.
3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
DenervationEXPERIMENTALRenal denervation using the Symplicty Catheter
Interventions
NameTypeDescription
Ardian Symplicity™ CatheterDEVICERenal denervation using the Symplicity Catheter
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * \>= 18 years of age. * a systolic blood pressure of 160 mmHg or greater. * receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening. * agrees to have the study procedure(s) performed and additional proce...

Countries:AustraliaPoland
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