Flow diverters – Challenges in Indian scenario, procter, financial, experience

1. FLOW DIVERTERS – Challenges in
Indian scenario, procter,
financial, experience ….
Vipul Gupta
Artemis Hospitals

2. Disclosures
Consultant
•Medtronic
•Stryker

3. Challenges in Indian Scenario
1.Costs
2.Few centres
3.Equipment
4. Documentation – publication
5. Training – newer device

4. Procter/training
• Animal lab
•International proctor
•Another experiences person helps
•Industry representative
•Observing cases

5. Medtronic -
•First 5 cases with a pipeline
proctor..
•next 15 cases with a trained
Medtronic rep..
• independent to do cases post 20..
• An independent user can further
go proctor cases in other centres..
•Multiple visits by Prof Boccardi

6. FRED Proctorship
Program:
During the initial launch phase 2 proctors were trained at a
high volume ProctorTraining centre by a senior protor
(Prof. Naci).
As FRED was an easier device compared to previous
generation Flow diverters and the physicians became
comfortable with Flow diverters in general the protocol of
proctorship was relaxed for proctorship.
Experienced sales representative ; In difficult cases, a
proctor was involved
No formal registry is maintained. However internally we are
tracking the cases and all adverse events are reported to
Microvention USA.

7. Protocol for Surpass Streamline
Launch
Level 1: Animal Lab Training
- One day training on live
animal under supervision of
Global proctors.
- Product technical presentation
and discussions with the
engineers from R&D
department
Level 2: Proctored Cases
- First few cases under the
guidance of a proctor.
- Flow modelling session before
the case.
- Strategy planning of the case
with the proctor

8. Protocol for Surpass Streamline
Launch
Level 3: Independent Cases
- If the proctor approves, it may
be after 2 or after 10 cases,
then device can be used
independently by the
physician.
- All cases shall be supported
by the Stryker representatives
Level 4: Become a Proctor!
- To become a proctor yourself
the physician needs to do 10 –
15 cases independently.
- First proctorship to be done in
presence of an International
Proctor.

10. p64
Proctoring-
5 x cases with phenox certified procter .
next 5 cases with company certified person .
The above criteria brings physician
under proctership.
3. P64 used inYr 2016 -51 Units .
Registry in India - we dont have it till now but
do follow up patient with physician

11. Cost
Is an issue
•Largely self paying patients
•Only certain segment of society can
afford – then too we are under pressure
Solution - ??
•Medtronic - Loan scheme
•Flexibility in cases of multiple devices
•Be careful in borderline indications

12. Training
•No formal guidelines for
training in INR
•Most centres /hospitals are
finding their own solutions
•Under pressure to do the cases
– no formal referral mechanism

13. Experience
•Few publications
•No organized registry
•No industry data
•(Fragmented market)
•Issue of use of different
devices with low volumes
•Among individuals – Dr Joseph
and Dr Limaye

14. Drugs …
•Anti-platelet and anti-coagulant protocol
•Most centres don’t haveVerify Now
•?? More thrombo-embolism in Indian cases
What do we do
•Pasugre l in most of cases
•Liberal use of heparin during cases
•Dual Anti-platelet drugs for one year followed
by Aspirin

15. Dilemmas
•Cavernous aneurysm with collaterals
•Small ICA aneurysms
•Bifurcation/distal
• aneurysms
•Small neck vs cost ???

16. Going forward …
Flow diverters
• Huge advancement
•One needs to understand the devices – training , no
•Industry should be meticulous in training
•Registries and publications are needed
•In the scenario of low volumes , one should be
careful in borderline indications …
•Innovative solutions for cost issues

17. For more information on:
STROKE & NEUROVASCULAR INTERVENTIONS:
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