FLOW DIVERTERS – Challenges in Indian scenario, procter, financial, experience ….

Vipul Gupta Artemis Hospitals

Disclosures

Consultant•Medtronic•Stryker

Challenges in Indian Scenario1.Costs2.Few centres 3.Equipment 4. Documentation – publication 5. Training – newer device

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

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

FRED Proctorship Program:                                                                                                                                                During the initial launch phase 2 proctors were trained at a high volume Proctor Training 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. 

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

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.

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 in Yr 2016 -51 Units .Registry in India - we dont have it till now but do  follow up patient with physician

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

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

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

Drugs …

•Anti-platelet and anti-coagulant protocol•Most centres don’t have Verify 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

Dilemmas

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

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

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