Downloaded 83 times
Uploaded byAbhiram Pushparaj
Clinical needs finding presentation tavi
This document discusses transcatheter aortic valve implantation (TAVI) and the risk of cerebral embolization during the procedure. TAVI is a minimally invasive procedure used to treat aortic stenosis that is growing rapidly worldwide. However, TAVI is associated with a risk of stroke between 2-4% within 30 days after the procedure due to cerebral embolization of debris. The document proposes developing a solution to reduce the risk of cerebral embolization and associated strokes during TAVI by at least 50%. It outlines criteria for an effective solution, competitive advantages over existing devices, hurdles to overcome, as well as the large market potential given the growth of TAVI procedures globally.
More Related Content
Clinical needs finding presentation tavi
- 1. TRANSCATHETER AORTIC VALVE IMPLANTATION(TAVI) Preventing Cerebral Embolization Schulich Innovation Research Day 2015
- 2. Team Mentor Sam Radhakrishnan, MD Director,Cardiac Catheterization Labs Schulich Heart Centre Team Yaron Arbel - MD, Clinical Fellow, Interventional Cardiology, Sunnybrook HSC Stefano Picone - Director of Finance, Colibri Technologies Abhi Pushparaj - PhD Candidate, Neuropharmacology, CAMH Jill Cates - MSc, Surgical Education, University of Toronto Mehdi Ataei - MSc, Mechanical Engineering, York University
- 3. Aortic Stenosis (AS) •Aortic Stenosis (AS): narrowing of the exit of the left ventricle of the heart • Symptoms include shortness of breath, fainting spells, angina, etc. • Prognosis is poor with 30-50% one year mortality rate for those that do not undergo a valve replacement HEALTHY STENOTIC Images from Edwards Lifesciences
- 4. Transcatheter Aortic Valves Implantation(TAVI) or Replacement (TAVR) • Relatively new minimally invasive procedure • First performed on patient in 2002 • Three retrograde approaches: • Transfemoral • Transaortic • Transubclavian • One anterograde approach: Transapical
- 5.
- 6. Projected Global TAVIGrowth
- 7. Projected Global TAVIMarket
- 8.
- 9. Timing of StrokePost-TAVI Stortecky & Windecker Circulation. 2012;126:2921-2924 Copyright © American Heart Association, Inc. All rights reserved.
- 10. Problem & NeedStatements Problem Statement • The risk of cerebral embolization occurring during TAVI is clinically problematic Need Statement • A solution capable of reducing the risk of cerebral embolization during TAVI by at least 50%
- 11. Stakeholder Analysis Insurers - Nochange in reimbursement Hospitals - Solution cost vs cost savings - Improved quality of care & outcomes - Increase TAVI volume Physicians - Ease of use/training - No complications - Facilitate adoption in lower risk patients Industry - Demonstrated in trial of reasonable size/cost - Increase TAVR volumes - Platform potential Patients - Less fear of SAEs - No change in co- pays - Minimize recovery time
- 12. Needs Criteria ● Clinicallymeaningful outcome o Reduction of clinical stroke by at least 50% without other SAEs ● Affordable for providers and payors o Less than 10% increase in device cost per procedure ● Non-negative time/workflow impact on physicians o Be trained & use with confidence, apply to lower-risk AS patients ● Industry path to profitability o Sales from solution + uptick in THVs
- 13. Global Market Size -Transcatheter heart valves cost $25,000 - $30,000 - Estimated price of solution is 5-10% of THVs (i.e. $1,250 - $3,000) - Lifetime cost of an ischemic stroke is $175,000* - 1.5% absolute risk reduction of stroke (50% of 3% incidence) - Represents expected cost savings of $2,650 per procedure Estimated from Credit Suisse TAVI estimates (Jan 2015)*Stroke.1996; 27: 1459-1466
- 14. Current Devices inTrials SENTINEL TRIGUARD EMBRELLA
- 15. Competitive Advantages OPTIMAL SOLUTIONSPECIFICATIONS Minimally Sized Catheter 6 French 9 French 6 French Easy Access Point(s) Radial Femoral Radial, Ulnar Brachial Aortic Arch Coverage (3 Arteries) BCA, LCCA BCA, LCCA LSA BCA, LCCA Partial LSA Ability to Capture Debris ✔ ✖ ✖ Convenient Imaging of Position Radiopaque Markers Contrast Agent Only Contrast Agent Only Reduce # of Cerebral Lesions - 65% -50% +80% Reduces Volume of Cerebral Lesion -57% -44% -46% Improve Neurological Outcomes Lower Ataxia Some Non- significant Not Yet Studied Procedural Success 94% 89% 93%
- 16. Hurdles for Creatinga Solution - Etiology of stroke is not clearly understood following TAVI (and other procedures) - Calcified debris; Native valve tissue; Thrombus - Potentially large trial to demonstrate reduced stroke incidence may be needed if effect size of solution is not high (~75%) - Value ($) of surrogate benefits are unclear - Reduced DW-MRI # of lesions & lesion volumes - Reduced neurocognitive deficits
- 17. Similar Risk amongstProcedures - Percutaneous Coronary Intervention - Coronary Artery Bypass Graft - Atrial Fibrillation Ablation - Surgical AVR Creating a platform solution willbe difficult but highly valuable
- 18.
- 19.
- 20. A1. Study Device 4valve sizes (18-29 mm annular range) 18Fr delivery system
- 21.