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SITELINE 2 Polyurethane

Phase 3

Bradycardia | Unknown | Other |Boston Scientific Corporation|Last Updated: Sep 29, 2011

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00180284SITELINE 2 PolyurethanePHASE3 COMPLETED 200Nov 1, 2004Feb 1, 2008Sep 29, 20111 United States
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Study Endpoints
Primary Endpoints
Pacing voltage threshold at 3 Months
3 months
Pacing impedance at 3 Months
3 months
Sensed amplitude at 3 Months
3 months
Lead complication-free rate up to 3 Months
3 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
SITELINE 2 Polyurethane (pacing lead)DEVICESITELINE 2 Polyurethane (pacing lead)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol * Patients selected must have the study lead as the initial implant of a permanent pacing lead in both the right atriu...

Countries:United States
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