CATCH : Mechanical Thrombus Retriever Neuroradiology by BALT Extrusion CATCH : Mechanical Thrombus Retriever

Atherosclerotic plaque What is a Stroke ? Stroke is a sudden interruption in the blood supply of the brain 85% 15% ISCHEMIC STROKE HEMORRHAGIC STROKE The blockage is caused by an abrupt blockage of arteries leading to the brain The stroke is caused by bleeding into brain tissue when a blood vessel or an aneurysm bursts blood clot Atherosclerotic plaque Now, how to use the LEO stent: it is a 3 steps process: With 20.000.000 cases per year, strokes are the 3rd cause of death in developed countries and a major cause of disability

An ischemic stroke has to be managed very quickly after the crisis by fibrinolysis therapy and/or embolectomy Intravenous fibrinolysis therapy A anti platelets is injected through patient vascular system to dissolve the clot H0 to H+3 H+3 Brain attack H+3 to H+8 For fibrinolysis contraindicated patients Now, how to use the LEO stent: it is a 3 steps process: Mechanical Thrombo Embolectomy The clot is mechanically removed thanks to a mechanical thrombus retriever with intravascular access Due to the short time limit, less than 3% patients get an intravenous fibrinolysis therapy

Up to now, mechanical thrombus retrievers were not very efficient… LASSOO (BALT Extrusion, Boston Sc., …) initially designed for coil retrieval high risk of clot fragmentation MERCITM (Concentric Medical) « corkscrew » system Less than 50% success rate IN-TIMETM (Boston Scientific) Dormia system too stiff for intracranial use I will first present you the LEO stent itself, from a technical point of view. Then, we will see what kind of use the LEO is designed for And I will finish by a description of the implantation process, for which there are some specific details that have to be taken into account. …so fibrinolytic therapy remained the most secure treatment

Then, we will see what kind of use the LEO is designed for BALT designed the CATCH, a new system based on the technology developed for the LEO intracranial stent I will first present you the LEO stent itself, from a technical point of view. Then, we will see what kind of use the LEO is designed for And I will finish by a description of the implantation process, for which there are some specific details that have to be taken into account. a 16-wire self-expandable basket allowing for a clot retrieval with a reduced risk of fragmentation

4 ORX markers for CATCH opening visualization CATCH thrombus retrieval system combines good navigation and excellent visualization 2,4F braided catheter VASCO+21 CATCH coupled to a pusher 4 ORX markers for CATCH opening visualization I will first present you the LEO stent itself, from a technical point of view. Then, we will see what kind of use the LEO is designed for And I will finish by a description of the implantation process, for which there are some specific details that have to be taken into account. Ø4mm 18mm Pusher’s ORX marker 1 distal ORX marker

THROMBO-EMBOLECTOMY GUIDELINES WITH THE CATCH DEVICE PER MEDICATION: heparin bolus intravenous injection (50 Ul/kg) at the beginning 1st CATCH procedure CATCH procedure is detailed here after If you carefully follow CATCH instructions for use as described hereafter, the same CATCH system can be used for these 5 procedures TIMI grade flow ≥ 2 In situ fibrinolysis through VASCO+21 20mg rtPA* TIMI grade flow ≥ 2 2nd, possibly 3rd CATCH procedure I will first present you the LEO stent itself, from a technical point of view. Then, we will see what kind of use the LEO is designed for And I will finish by a description of the implantation process, for which there are some specific details that have to be taken into account. TIMI grade flow ≥ 2 Complementary in situ fibrinolysis through VASCO+21 max. 0,9mg/kg rtPA* TIMI grade flow ≥ 2 4th, possibly 5th CATCH procedure *only if in situ fibrinolysis procedure is recognized by local health authorities and if patient has no contraindication to fibrinolysis

CATCH system has to used according following procedure CATCH procedure Positioning & deployment Clot & CATCH retrieval CATCH resheathing If needed* *If TIMI ≥ 2 after the first CATCH procedure, the system can be resheathed to be used for another procedure, and so on up to 5 procedures

CATCH Procedure (1/2) Positioning and deployment CATCH resheathing Clot & CATCH retrieval Positioning & deployment CATCH Procedure (1/2) Positioning and deployment Use a 8F guiding catheter (ENVOY8F for example) or a CORAIL8F+ or a long introducer (IVA6F80) Run the VASCO+21 catheter through the thrombus and position it at least at 2 cm downstream from the thrombus After removing the microguidewire, introduce the CATCH into VASCO+21 and push it until it reaches the tip of the catheter 2 cm mini VASCO+21 Microguidewire Deploy the CATCH downstream out of the VASCO+21 from the thrombus by pulling the catheter The radiopaque marker of the pusher should be at least 1cm from that of the VASCO+21 ORX CATCH ORX VASCO ORX Pusher Now, how to use the LEO stent: it is a 3 steps process: Do not push the CATCH out of the catheter: its tip may damage the artery Using a CORAIL8F will allow to inflate the balloon to facilitate clot retrieval

CATCH Procedure (2/2) Clot and CATCH retrieval CATCH resheathing Clot & CATCH retrieval Positioning & deployment CATCH Procedure (2/2) Clot and CATCH retrieval If you use a CORAIL8F, inflate the balloon Slightly pull back, with pauses, the assembly CATCH+Catheter to move the thrombus down to the guiding catheter, Do not try to pull back the CATCH into the VASCO+21 catheter When approaching the guiding catheter, turn off its perfusion. Get out the assembly CATCH+Catheter through the guiding catheter Suck the guiding catheter inner lumen (blood and clot), with a syringe 20ml minimum Turn on the guiding catheter perfusion Now, how to use the LEO stent: it is a 3 steps process: Clean carefully the CATCH in a physiological serum or sterile water bowl and/or under a syringe jet

CATCH system can be re-used up to 5 times if the resheathing procedure is strictly respected CATCH resheathing Clot & CATCH retrieval Positioning & deployment Before resheathing the CATCH, carefully check if its basket is not damaged Trying to resheath the CATCH without the hub will destroy the basket A HUB PACKED WITH THE CATCH ENABLES IT RESHEATHING

A hub is packed with the CATCH to allow its correct resheathing CATCH resheathing Clot & CATCH retrieval Positioning & deployment A hub is packed with the CATCH to allow its correct resheathing 1 CATCH Take the basket + pusher out of the VASCO+21 by its distal tip VASCO+21 Pusher Basket 2 Resheathing hub Insert the proximal part of the pusher inside the proximal hole of the resheathing hub 3 Introducing sheath Insert the distal part of the introducing sheath on the proximal part of the pusher 4 1 2 Gently pull on the pusher until the basket passes through the hub inside the sheath Introducing sheath Resheathing hub CATCH 3 4

Cases already done show a high success rate for the CATCH system EXAMPLES OF CASES Occlusion of the medium cerebral artery (Pr René Chapot, Limoges - France) CASE #1 Occlusion of the basilar artery (Pr René Chapot, Limoges - France) CASE #2 Occlusion of the medium and anterior cerebral arteries (Pr Schroth and Dr Remonda, Bern - Switzerland) CASE #3

CASE #1 : Occlusion of the medium cerebral artery (Pr René Chapot, Limoges - France) BEFORE microguidewire Vasco+21 CATHETER POSITIONING Vasco+21 CATCH CATCH POSITIONING

CASE #1 : Occlusion of the medium cerebral artery (Pr René Chapot, Limoges - France) Vasco+21 CLOT RETRIEVAL CATCH AFTER RETRIEVED CLOT

CASE #2 : Occlusion of the basilar artery (Pr René Chapot, Limoges - France) BEFORE CATCH POSITIONING CATCH Vasco+21 CATCH OPENNING CATCH

CASE #2 : Occlusion of the basilar artery (Pr René Chapot, Limoges - France) CLOT RETRIEVAL AFTER RETRIEVED CLOT

CASE #3 : Occlusion of the medium and anterior cerebral arteries (Pr Schroth and Dr Remonda, Bern - Switzerland) BEFORE CATCH POSITIONING CATCH Vasco+21

AFTER FIRST USE (Anterior Cerebral) CASE #3 : Occlusion of the medium and anterior cerebral arteries (Pr Schroth and Dr Remonda, Bern - Switzerland) AFTER FIRST USE (Anterior Cerebral) CLOT RETRIEVED

Frequently Asked Questions Which guiding catheter do we use with a CATCH ? Minimum guiding catheter diameter is 6Fbut the more the diameter is high, the less there is clot fragmentation risks during the retrieval. We would advise a 8F guiding catheter. CORAIL8F is particularly indicated since the balloon inflation allows a very efficient thrombo-aspiration in addition to mechanical retrieval. Is one CATCH use sufficient to unblock an artery ? In some cases, one use allow to completely retrieve the clot however, it is often necessary to go through several times, up to five times. This can be done with the same device, if the CATCH is well resheathed according to the detailed resheathing procedure and is washed according to IFU. How do we have to wash the CATCH between two uses ? You should shake the CATCH basket in a physiological serum bath. If some pieces remain in the basket, it is possible to use the pressure of a syringe jet to get rid of them. Do you have or Can you use fibrinolysis during CATCH use ? Yes. Within the European multicentric study we are presently conducting, the protocol holds that, if the artery is not completely unblocked after the CATCH first use, 20m rtPA should be locally injected with the microcatheter. After the third use, if the artery is not still completely unblocked, a complementary rtPA local injection can be done with a total maximum of 0,9mg/kg rtPA. In which arteries can the CATCH be used ? CATCH can be used in any intracranial artery which diameter is at least 2mm. For peripheral and venous sinus use, we developed another reference, CATCH9, with a bigger diameter from 5 to 10mm. What is the CATCH success rate ? We do not have yet any statistics. However, users’ feedbacks make us think that it will be far higher than MERCI success rate. Two multicentric studies are under way to get a more precise estimation of this device success rate. Our first feedbacks, with experienced users following the procedure described here above, give around 80% success rate.

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