Balton From Poland

Warsaw, September 1-4, 2008

TECHNICALTECHNICAL PARAMETERSPARAMETERSAnti-proliferative agentAnti-proliferative agent paclitaxel (ca. 1paclitaxel (ca. 1µµg/mmg/mm22))

PolymerPolymer BiodegradableBiodegradable

Stent diameterStent diameter 2.25 – 5.00 mm2.25 – 5.00 mm

Stent lengthStent length (mm) (mm) 8, 10, 12, 18, 10, 12, 155, 18, 2, 18, 222, 2, 25, 29, 345, 29, 34

Stent platformStent platform stainless steel 316Lstainless steel 316L

Strut thicknessStrut thickness 0.12mm0.12mm

DesignDesign closed cell - closed cell - for uniform drug distribution and for uniform drug distribution and coverage of the vessel wall coverage of the vessel wall

FerromagnetismFerromagnetism nonenone

MRIMRI safesafe

Use with guide wireUse with guide wire max max .014”.014”

Use with guiding catheterUse with guiding catheter 5F5F**

Length reduction after deploymentLength reduction after deployment <<00.5.5%%

Recoil Recoil <2%<2%

Stent crimped profileStent crimped profile .0.04040” (for stent diameter 3mm)” (for stent diameter 3mm)

Distal shaft diameterDistal shaft diameter 2.7F/0.90 mm2.7F/0.90 mm

Proximal shaft diameter Proximal shaft diameter 2F/0.65 mm2F/0.65 mm

Nominal pressureNominal pressure / RBP / RBP 10 10 atm / 16 atmatm / 16 atm

* * (for stent diameter(for stent diameter 4.54.5 and and 5.0 mm 5.0 mm use guiding catheter use guiding catheter 6F6F))Warsaw, September 1-4, 2008

DEGRADATION OF TESTED POLYMERDEGRADATION OF TESTED POLYMER

The surface of the stent after 1 week

The surface after 8 weeks

Residual polymer left on the stent surface after 8 weeks

The samples of stents covered with tested polymer and removed from isotonic salt solution at different time points


EXCELLENT CEXCELLENT COATING OATING IINTEGRITYNTEGRITY OF LUC-CHOPINOF LUC-CHOPIN22 STENT STENT


COMPETITORCOMPETITOR SIROLIMUSSIROLIMUS ELUTINGELUTING STENTSTENT


- WCC Barcelona 2006, - TCT 2005, 2006, 2008 Washington- ESC Vienna, 2007- International LDDR meeting, Geneva 2006, 2008- Interventional cardiology meeting, Snowmass 2008

LIST OF ABSTRACTS PRESTENTED LIST OF ABSTRACTS PRESTENTED AT INTERNATIONAL CONGRESSESAT INTERNATIONAL CONGRESSES

1st prize for Balton!


Technical parameters of stentTechnical parameters of stent

MaterialMaterial steel 316 Lsteel 316 L

DesignDesign closed cellclosed cell

Strut thicknessStrut thickness 0.12 mm0.12 mm

Stent diameterStent diameter 2.25 – 5.00 mm2.25 – 5.00 mm

Stent lengthStent length 8, 10, 12, 18, 10, 12, 155, 18, 2, 18, 222, 2, 25, 29, 345, 29, 34 mm mm

MRIMRI safesafe

Use with guide wireUse with guide wire .014”.014”

Use with guiding catheterUse with guiding catheter 5F *5F *

Length reduction after Length reduction after deploymentdeployment <<00.5.5%%

Recoil Recoil <2%<2%

Stent crimped profileStent crimped profile .038”/0.97 mm .038”/0.97 mm (for stent diameter 3mm)(for stent diameter 3mm)

Distal shaft diameterDistal shaft diameter 2.7F/0.90 mm2.7F/0.90 mm

Proximal shaft diameter Proximal shaft diameter 2F/0.65 mm2F/0.65 mm

Nominal pressureNominal pressure/RBP/RBP 10 10 atm/16atmatm/16atm

ChopinChopin2 2 TMTM - STENT FOR CORONARY ARTERIES - STENT FOR CORONARY ARTERIESWITH DELIVERY SYSTEMWITH DELIVERY SYSTEM

* * (for stent diameter(for stent diameter 4.54.5 and and 5.0 mm 5.0 mm use guiding catheter use guiding catheter 6F6F))


Events n=97

Death 0 (0%)

Myocardial infarction:-Q wave-- non-Q wave

0 (0%)

0 (0%)

Emergent CABG 2 (1.9%)

TLR* 22 (22.6%)

Revascularization per patient 0.24

Cumulative MACE 24 (24.7%)

Late thrombosis 0 (0%)

ChopinChopin22 STENT REGISTRY STENT REGISTRY - CLINICAL OUTCOMES AFTER 6 MONTHS- CLINICAL OUTCOMES AFTER 6 MONTHS

*clinically driven


They feature high functional parameters quality:- Thin walls, allowing maximum flow.- High pressure resistant 100 atm (1450PSI).- Relevant softness, flexibility and curvature, facilitating

catheter introduction and advancement.- Good visibility in X-rays.- Perfectly smooth surface and very good finishing of

side holes.- Tip atraumatic for the vessels.

Each catheters features a Luer-Lock connector, making the set hermetic.

Some catheters size 5F and 6F are available in reinforced configuration with stainless steel braided.

All catheters feature the same softness in distal parts (unbraided).

CATHETERS FOR ANGIOGRAPHYCATHETERS FOR ANGIOGRAPHYCATHETERS FOR ANGIOGRAPHYCATHETERS FOR ANGIOGRAPHY


CARDIOLOGICALCARDIOLOGICAL INTRODUCERINTRODUCER

Radiological introducer

Radial artery cardiological introducer


GUIDEWIRESGUIDEWIRESGUIDEWIRESGUIDEWIRES

For interventional cardiology & radiology The tip of the guidewire is appropriately shaped andatraumatic for optimal patient's security Designed for complex vascular interventions including"cross-over" techniques.

Guidewires Size

Steel guidewires .022”, .035”, .038”

Hydrophilic guidewires .032”, .035”, .038”

Micro guidewires .007”, .009”, .014”

Lunderquist guidewires .035”

PTFE coated guidewires .018”, .022”, .025”, .035”, .038”

PTCA guidewire „Rider” .014”


PTCA GPTCA GUIDEUIDE WIRESWIRES „RIDER” – WITH „RIDER” – WITH HYDROPHILIC COATINGHYDROPHILIC COATINGPTCA GPTCA GUIDEUIDE WIRESWIRES „RIDER” – WITH „RIDER” – WITH HYDROPHILIC COATINGHYDROPHILIC COATING

Guidewire Size Length Type

PTCA guidewires

.014” 175 – 300 cm„J”

Straight

PTCA guide wires technical data:PTCA guide wires technical data:

•Material: steel and platinum•Length 175 -300 cm•Broad range of stiffness•Radiopaque marker of min. 25 mm length•Straight and "J" shaped guide wire tips•Excellent steerability•Special coating for optimal crossing of tortuous and narrow vessels•Stiff proximal shaft•Good visibility of guide wire tip•Optimal torque control 1:1

The guide wires are available in several kinds of flexibility of the distal tip:

•with high floppy tip – HF•with floppy tip - F, •with medium tip - M, •with stiff tip – S•with high stiff tip – HS

Guide wires are available with additional strengthening in their proximal spiral part, which enables their for the delivery of stents:

•stent support floppy – STF•stent support medium – STM•stent support stiff – STS.


PERIPHERAL ANGIOPLASTY CATHETERPERIPHERAL ANGIOPLASTY CATHETER PBA PBAPERIPHERAL ANGIOPLASTY CATHETERPERIPHERAL ANGIOPLASTY CATHETER PBA PBA

Balloon diameter 4 - 12 mm

Balloon length 20 - 100 mm

Use with introducer For balloon diameter 4 – 7 mm 6F

Use with introducer For balloon diameter 8 – 10 mm 7F

Use with introducer For balloon diameter 12 mm 8F

Nominal pressure 6 atm

Rated Burst Pressure

RBP10 atm

Catheter length 80 or 110 cm

Type of delivery system

OTW


Balloon diameter 1.5 – 5.0 mm

Balloon length 10 - 40 mm

Use with guiding catheter

For balloon diameter 1.5 – 4.0mm 5F

Use with guiding catheter

For balloon diameter 4.5 – 5.0mm 6F


Rated Burst Pressure

RBP16 atm

Catheter length 140 cm

Type of delivery system RX

CORONARYCORONARY ANGIOPLASTYANGIOPLASTY CATHETERCATHETERCORONARYCORONARY ANGIOPLASTYANGIOPLASTY CATHETERCATHETER

NEWNEW VERSIONVERSIONNEWNEW VERSIONVERSION


NefroNefroTMTM - STENT FOR RENAL ARTERIES - STENT FOR RENAL ARTERIESWITH DELIVERY SYSTEM - Rapid Exchange WITH DELIVERY SYSTEM - Rapid Exchange (RX)(RX)

Material 316 stainless steel

Guide wire Max .014”

Guiding catheter 6F


Rated burst pressure 12 atm

Available diameters 5.0 – 7.0mm

Lengths 8.0 – 22.0mm


NeptunNeptunTMTM - STENT FOR PERIPHERAL - STENT FOR PERIPHERAL VESSELS WITH DELIVERY SYSTEMVESSELS WITH DELIVERY SYSTEM

Stent diameterStent diameter 4 - 10 mm4 - 10 mm

Stent lengthStent length 16 - 100 mm16 - 100 mm

Use with guide Use with guide wirewire .035”.035”

Use with Use with introducerintroducer for stent diameter 4 – for stent diameter 4 – 66 mm mm 6F6F

Use with Use with introducerintroducer for stent diameter for stent diameter 77 – 9 mm – 9 mm 7F7F

Use with Use with introducerintroducer for stent diameter 10 mmfor stent diameter 10 mm 8F8F

Nominal PressureNominal Pressure 6 6 atmatm

Rated Burst Rated Burst PressurePressure 10 10 atmatm

Catheter lengthCatheter length 80 or 110 cm80 or 110 cm

Delivery system Delivery system typetype OTWOTW


JaguarJaguarTMTM -SELF EXPANDING NITINOL -SELF EXPANDING NITINOL STENT WITH DELIVERY SYSTEMSTENT WITH DELIVERY SYSTEM

Material Nitinol wire with platinum markers

Available diameters 4.0 – 10.0 mm

Lengths 15.0 – 120.0 mm

The JaguarSM self-expanding stent with a delivery system is recommended for percutaneous intravascular deployment in patients with atherosclerotic, radiation and trauma-induced stenoses.

The soft and rounded tip of delivery system is atraumatic towards the arterial wall.

Special construction of delivery system enable to correction of stent position inside a vessel even after the partial stent release


TTrachearacheall and esophag and esophageal stent - TOReal stent - TORTracheal and esophageal Tor stent is made of nitinol, which is material of high biocompatibility.Tor stent with the delivery system provides high efficiency and comfort of application during an attempt to restore patency of highly stenotic trachea, bronchi or esophagus.Thanks to its perfect elasticity the stent perfectly matches the shape of the trachea and esophagus.A special construction of the stent protects against migration.The delivery system is characterised by high elasticity.Atraumatic endings of the system minimise the risk of damage during the procedure.

TECHNICAL INFORMATION:

Stent made of nitinol Diameter of stent: 15 - 30 mm Length of stent: 20 – 80 mm Very high radial force of the stent Rounded endings of the stent which efficiently

protect the walls of the trachea and esophagus against damage

Very good stent radiopacity – platinum markers on the stent endings which allow for precise implantation

Atraumatic ending of the delivery system Size of the delivery system: 14F Length of delivery system: 50, 60, 70 cm TORTOR


Large vessel catheterization set with:- Single lumen catheter- Double lumen catheter- Triple lumen catheter- Four lumen catheter

Anaesthesia sets


Thermodilution set “BALKAT”

Spinal anaesthesia needles


Dialysis sets

Hemodialysis needles


Embolectomy catheters

Aortic catheters

Catheter for bile duct’s

Drains


- Nephrostomy sets

Nephrostomy & cystostomy set

- Cystostomy sets

- Ureteral catheters

- Sets for stent introduction


Insemination catheters

Histerosalpingography sets

HSG catheters


Balton From Poland

Documents

Transcript of Balton From Poland