project clot: clot detection device for stroke prevention team atriumph: erica kim, angela li, sam...
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Project Clot: Clot Detection Device for Stroke
Prevention
Team Atriumph: Erica Kim, Angela Li, Sam Vallagomesa, Michael Williams-Hart
Background & Motivation
Agenda
Market & Customer Analysis
Design Specifications
Moving Forward
Atrial Fibrillation
Most common type of arrhythmia
Affects 3.2 million people in the U.S.
Atrial Fibrillation
fatigue difficulty breathing dizziness
Embolic Stroke in AF Patients
Accounts for >15% of all strokes in the U.S
No effective method for stroke prevention in AF patients
Detection treatment
Left Atrial Appendage (LAA)
Embolic Stroke in AF Patients
AF Episode Reduced LAA function
Blood stasis Clot Formation
Regain LAA function
Pump out clot
Embolic stroke
Clot Formation
Blood stasis Clot
Formation
Regain LAA function
Pump out clot
Embolic stroke
Design and test a clot detection & monitoring device to prevent
embolic stroke for patients with atrial fibrillation
Project Clot Team Atriumph
Transesophageal Echocardiogram (TEE)
Description
Uses high frequency sound waves to produce images of the posterior side of the heart
Transesophageal Echocardiogram (TEE)
Advantages
100% sensitivity
99% specificity
Current standard of care
Transesophageal Echocardiogram (TEE)
Disadvantages
Moderately invasive
Expensive
Requires skilled technician or cardiologist
Description
Cardiac Computed Tomography (CT)
Uses x-ray to produce cross-sectional images of a scanned object
Cardiac Computed Tomography (CT)
Advantages
96% sensitivity
92% specificity
Non-invasive
Cardiac Computed Tomography (CT)
Disadvantages
Uses radiation
Expensive
Requires clinical setting
Clot Detection Devices are Novel
TEE & CT used only before ablation procedure
Specifically used for clot detection
Permanent implant continuously monitors patient
Notifies patient YES or NO to clot formation outside clinical setting
Are not monitoring techniques
Requires clinical setting
Clot Detection Devices are Novel
TEE & CT used only before ablation procedure
Specifically used for clot detection
Permanent implant continuously monitors patient
Notifies patient YES or NO to clot formation outside clinical setting
Are not monitoring techniques
Requires clinical setting
Clot Detection Devices are Novel
TEE & CT used only before ablation procedure
Specifically used for clot detection
Permanent implant continuously monitors patient
Notifies patient YES or NO to clot formation outside clinical setting
Are not monitoring techniques
Requires clinical setting
Market AnalysisEstimated Market Size Willingness to Pay
Predicted Market Share
119,250 patients/year
approx.$2,500
15% $45 million/year
Estimated Financial Opportunity
Market AnalysisEstimated Market Size Willingness to Pay
Predicted Market Share
119,250 patients/year
approx.$2,500
15% $45 million/year
Estimated Financial Opportunity
Market AnalysisEstimated Market Size Willingness to Pay
Predicted Market Share
119,250 patients/year
approx.$2,500
15% $45 million/year
Estimated Financial Opportunity
Market AnalysisEstimated Market Size Willingness to Pay
Predicted Market Share
119,250 patients/year
approx.$2,500
15% $45 million/year
Estimated Financial Opportunity
Market AnalysisEstimated Market Size Willingness to Pay
Predicted Market Share
119,250 patients/year
approx.$2,500
15% $45 million/year
Estimated Financial Opportunity
Clinician Patient
User
COMPANYLOGO
Customer Needs Analysis
COMPANYLOGO
Customer Needs Analysis
Accuracy Safety Ease of Use
Maintenance
Cost
COMPANYLOGO
Translating Needs to Specs
Accuracy Safety Ease of Use
Maintenance Cost
COMPANYLOGO
90-95% Sensitivity & Specificity
Safety Ease of Use
Maintenance Cost
Translating Needs to Specs
COMPANYLOGO
Sensitivity & Specificity
Safety Ease of Use
Maintenance Cost
Translating Needs to Specs
COMPANYLOGO
Sensitivity & Specificity
Biocompatible
Ease of Use
Maintenance Cost
Translating Needs to Specs
COMPANYLOGO
Sensitivity & Specificity
Biocompatible
Ease of Use
Maintenance Cost
Translating Needs to Specs
COMPANYLOGO
Sensitivity & Specificity
Biocompatible
Maintenance Cost
User Friendly Interface
Translating Needs to Specs
COMPANYLOGO
Sensitivity & Specificity
Biocompatible
Maintenance Cost
User Friendly Interface
Translating Needs to Specs
COMPANYLOGO
Sensitivity & Specificity
Biocompatible
? Cost
User Friendly Interface
Translating Needs to Specs
COMPANYLOGO
Sensitivity & Specificity
Biocompatible
? Cost
User Friendly Interface
Translating Needs to Specs
COMPANYLOGO
Design Specifications
Sensitivity & Specificity
Biocompatible
User Friendly Interface
? Competitive Pricing
Mission Statement
Blood stasis Clot
Formation
Regain LAA function
Pump out clot
Embolic stroke
Design an intracardiac device that detects clots in the LAA
accurate safe user friendly
Moving Forward
mid Oct. 2015
end of Oct. 2015
early Nov. 2015
Mar. 2016
Commit to a modality of sensing technology
Finalize our first design (iterative process)
Create first working prototype (iterative process)
Complete and file a provisional patent
Complete final design and prototype
end of Sept. 2015
Project Clot Team Atriumph
Regain LAA function