TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI)

Preventing Cerebral Embolization

Schulich Innovation Research Day 2015

TeamMentor

Sam Radhakrishnan, MD

Director, Cardiac Catheterization Labs

Schulich Heart Centre

TeamYaron 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

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 STENOTICImages from Edwards Lifesciences

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

TAVI Procedure

 

Projected Global TAVI Growth

Projected Global TAVI Market

The Problem: STROKE

60-80% 2-4%

Timing of Stroke Post-TAVI

Stortecky & Windecker Circulation. 2012;126:2921-2924 Copyright © American Heart Association, Inc. All rights reserved.

Problem & Need Statements

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%

Stakeholder Analysis

Insurers- No change 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

Needs Criteria● Clinically meaningful outcome

o Reduction of clinical stroke by at least 50% without other SAEs

● Affordable for providers and payorso 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 profitabilityo Sales from solution + uptick in THVs

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

Current Devices in Trials

SENTINEL TRIGUARD EMBRELLA

Competitive AdvantagesOPTIMAL SOLUTION SPECIFICATIONS

     

Minimally Sized Catheter 6 French 9 French 6 French

Easy Access Point(s) Radial Femoral Radial, UlnarBrachial

Aortic Arch Coverage (3 Arteries) BCA, LCCA BCA, LCCALSA

BCA, LCCAPartial LSA

Ability to Capture Debris ✔ ✖ ✖

Convenient Imaging of Position RadiopaqueMarkers

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%

Hurdles for Creating a 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

Similar Risk amongst Procedures

- Percutaneous Coronary Intervention- Coronary Artery Bypass Graft- Atrial Fibrillation Ablation- Surgical AVR

Creating a platform solution will be difficult but highly valuable

Thank You!

Appendix

A1. Study Device

4 valve sizes (18-29 mm annular range)

18Fr delivery system

A2. Access Routes