Bifurcation Balloon & Stent Delivery System Talk Title Edo Kaluski MD, FACC, FESC, FSCAI Director of Cath-Lab & Interventional Cardiology, University Hospital & UMDNJ Newark, NJ, USA Professor of Medicine @ NJ Medical School

Disclosure Owner of 2EKMD-LLC (the sole owner of USA patent 8,043,320B2: “Bifurcated balloon & delivery system

Why Bifurcation Balloon? To optimize POBA based bifurcation PCI currently treated with “kissing balloons” (including drug eluting balloons). To optimize bifurcation stenting. (currently treated with “final kissing balloon”) To serve as a universal platform for bifurcating stents. (currently no such platform)

Current Bifurcation PCR in USA 99% are treated with DES that are not “bifurcation dedicated”. Cases in which the side branch is stented [primary or secondary (provisional)] it is recommended to finish with final “Kissing Balloon” inflation.

1. “Kissing Balloons” ignore the bifurcation anatomy!

Calculation of Vessel Diameter Growth Side-branch (SB) Diagonal Distal Main branch (DMB) Distal LAD *per Murray's law*: PBD2=SBD2 + DMB2 3.62= 32 + 22 2mm 3mm 3.22^-3.6* mm Proximal Main branch (PMB) Proximal LAD ^ Proximal growth of 0.22 mm diameter/cm length

KISSING BALLOONS (2 & 3 mm) Distal Main branch 3.22-3.60 2mm 3mm 3 Sidebranch 2 A=3.0mm B=3.22-3.6mm 2 3 Proximal Main branch 5mm (assuming nominal) In our attempt to better our patient this is what we call

This is “Kissing” Stress /Strain (5 mm stretch to 3.5 mm vessel) Distal Main branch 3.22-3.6 2mm 3mm 3 Sidebranch 2 A=3.0mm B= 3.22-3.6 mm 2 3 Proximal Main branch 5mm (assuming nominal)

This is the kissing “Waist” Distal Main branch 3.0-3.25 2mm 3mm 3 Sidebranch 2 A=3.0mm B=3.22-3.6mm 2 3 Proximal Main branch 5mm (assuming nominal)

2. Kissing Balloons within stents ignores the bifurcation anatomy!

Bifurcation Stents Have Been Here > 7 years ….. It is the delivery system that is missing!!!! Eurointerv. 2008;3:558-56

DBS Bifurcating Stent (Cordis) Eurointerv. 2008;3:558-56

Medtronic Bifurcation Stent Riding on 2 coaxial balloons

Shortcomings of DBS & Medtronic Bifurcation Stents Balloon Eliptical geometry achieved (best case scenario) with short diameter (d) that is half as long diameter (D) (8 shape with unopposed struts). If some resistance is encountered (R) and MLD (d’) will be further compromised. Bulky & clumsy delivery systems (subject to tangling & stent limbs mal-orientation) Requires at least 2 operators (inflating balloons simultaneously) d balloon Balloon R d’ R Balloon

3. Treating bifurcations without dedicated bifurcating stent is suboptimal!

a. Suboptimal wiring of side-branch

Optimal, suboptimal & worse wiring

b. Failure to enter the side-branch after main branch stenting and perform SB stenting.

Procedure Characteristics (NORDIC 1 & BBC 1) Frequency of failing to rewire  execute final kiss (25% did not receive final kiss among 2 stent arm of NORDIC 1 & BBC 1) Procedure Characteristics (NORDIC 1 & BBC 1) Simple (n=457) Complex (n=456) P value SB stented (%) 3.5 92.3 <0.001 Crush (%) - 59.6 Culotte (%) 25.9 Other (%) 12.9 Final kissing balloon (%) 28.3 75.3 Procedural success (%) 95.4 94.5 0.43 Procedural time (mins) 59.1 77.4 0.001 Fluoroscopy time (mins) 15.1 21.5 Contrast volume (mls) 243.2 297.9 In the Simple group, 16 patients (3.5%) required a T-stent and 129 patients (28.3%) underwent kissing balloon dilatation post stenting. In the Complex group, 272 (59.6%) patients had culotte stenting, with 342 (75.3%) having final kissing balloon inflation. This table also demonstrates that procedural, fluoroscopy time and contrast volumes were significantly greater in the Complex group. 21

c. Frequency of suboptimal results of sidebranch (coverage, expansion, luminal struts )

d.The time, resources & cost spent on bifurcation procedure.

e. Elements of unpredictability (of both MB & SB results)!

f. Inability to angiographically assess the hemodynamic significance of SB compromise after main branch stenting.

Prior Art: Bifurcation Balloon Drawbacks: Bulky (2 wires & 2 wire lumens) Both balloon arms arrive together at the bifurcation (setup for wire Tangling and mal-orientation)

1.Extension tube with wire lumen for SB Innovation: 1.Extension tube with wire lumen for SB (kink resistant & flexible) hence SB wire travels outside the balloon (like budy wire). Sidebranch balloon Balloon tip Creates complete wire separation at the distal 15 cm (no tangling) 2) Enhances side branch orientation (prevents mal-orientation)

Boston Scientific IVUS Catheter Uses the Same principal

2. One balloon lumen inflating all limbs 3. Only 1 wire crosses via balloon shaft Sidebranch balloon Balloon tip

Wires are threaded into both vessels. (just like kissing balloon method)

Bifurcating Balloon advanced over wires. The extension tube Sidebranch balloon Balloon tip Bifurcating Balloon advanced over wires. The extension tube orients the SB balloon into the SB.

Bifurcating balloon positioned at bifurcation

SB Wire does not have to be removed prior to inflation

Bifurcation balloon inflated (side branch wire can be removed or maintained in side branch)

Stent Platform With appropriate crimping the “Bifurcation Balloon” Hyperflexible (Slinky-like) segment With appropriate crimping the “Bifurcation Balloon” can be used to deploy a bifurcating stent.

After stent deployment: Delivery System Removal Withdrawing balloon over single wire or both wires (after rewiring or leaving SB wire under stent struts)

Bifurcation balloon can also be lead by 2 extension peaces with no central wire

The device has been patented.

Currently in Prototype trials with CREGANNA TACTX Medical

CREGANNA TACTX

Summary: Bifurcations Bifurcations are “The Achilles heal” of interventional cardiology Requires currently high skills & exceptional costs and yields relatively suboptimal outcome. Providing a universal solution to bifurcation ballooning & stenting will have tremendous impact on cardiovascular medicine including: left main stenting, popliteal and tibio-peroneal stenting, carotid and others.

Summary: Bifurcations The contemporary bifurcation balloons and stent delivery system should be anatomically suitable & compatible and easy to use. Any anatomical suitable “Bifurcation balloon” will also optimize bifurcation stenting, and PCR done by other dedicated & non-dedicated bifurcation solutions.