WWW.CARDIONOVUM.EU

Rev. no.: L-04007EN

CARDIONOVUM Sp. z o.o. ul. Panska 73 00-834 WarsawPoland

Phone: +48 - 22 31 47 151Fax: +48 - 22 31 47 151E-Mail: cardionovum@epoczta.pl

CARDIONOVUM Inc. 29229 Canwood Street Suite 202, Agoura Hills, CA 91301 USA

Phone: +49 (0) 228 - 90 90 59 - 0Fax: +49 (0) 228 - 90 90 59 - 20E-Mail: info@cardionovum.eu

CARDIONOVUM GmbH Am Bonner Bogen 2 53227 Bonn Germany

LEGFLOW RX/OTW PACLITAXEL RELEASING PTA BALLOON DILATATION CATHETER.

®

FACTSON

DEBs

WITH UNIQUE ‘SAFEPAX’ DRUG COATING TECHNOLOGY

Highest patient safety and clinical efficacy.

SUCCESSFUL PREVENTION AND TREATMENT OF RESTENOSIS AFTER PERIPHERAL INTERVENTION.

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LEGFLOW RX/OTWPaclitaxel Releasing Peripheral Balloon Dilatation Catheter

®

THE LEGFLOW BALLOONDRUG COATING QUALITYIS A MAJOR STEP BEYOND CONTEMPORARY FIRST AND SECOND GENERATION DEB COATINGS.

LEGFLOW SAFETY:Only the smallest PTX crystals appear safe enough to bear no risk of adverse embolic or thrombotic effects or

obstructing the smaller distal vasculature. LEGFLOW ensures a high patient safety by non-visible 0.1µm smal-

lest PTX particles leapfrogging ahead of 2.0-3.0µm large Paclitaxel crystals on most other DEBs.

THE UNIQUE LEGFLOW INNOVATION:The step beyond contemporary first and second generation DEB coatings which had to compromise on

vulnerable balloon coating mixtures out of a high water soluble drug excipient with relatively large PTX crystals.

LEGFLOW COATING INTEGRITY:The indestructible, structural balloon coating integrity, combined with a protective drug coating finesse, does

not require the use of an extra insertion tool.

LEGFLOW ‘SAFEPAX’ PERFORMANCE:Consistent and predictable drug delivery to the artery lesion site results in a homogenous and maximized drug

absorption into the arterial tissue.

LEGFLOW PROTECTIVE BALLOON COATING:The LEGFLOW Paclitaxel balloon surface coating cannot be wiped or fall off the balloon during catheter pre-

paration, insertion or manipulation. LEGFLOW prevents endangerment of cathlab personnel, and guarantees

a safe and predictable drug delivery to the target lesion site.

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Effective DEB PTX drug-transfer

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The LEGFLOW RX/OTWis indicated for the treatment of:

Paclitaxel transfer into the vessel wall for clinically effective anti-proliferative restenosis-prevention. Paclitaxel inhibits

SMC proliferation and significantly reduces neointimal hyperplasia.

0.1µm UNSURPASSED INVISIBLY SMALL TRANSLUCENT PTX PARTICLES.

critical limb ischemia (CLI)

de-novo and restenotic lesions of the SFA

popliteal artery and BTK (Below-The-Knee) artery lesions

LEGFLOW RX/OTW®

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LEGFLOW ‘SAFEPAX’ technology utilizes the clini-

cally important, nanocrystalline PTX particles. Even

if PTX particles would broke free they would be too

small to cause any embolic or thrombotic effect.

1. LEGFLOW PTX coating of 0.1µm appears trans-

lucent under light reflection.

2. Other DEB`s with ‘unstable’ and brittle balloon

coatings, consisting of large (visible) PTX particles,

bear a risk for physicians and patients.

Microscopy of the LEGFLOW balloon surface showing no visible PTX particles

‘Stable’ vs. ‘unstable’ DEB PTX coating

DEB SAFETY FIRST!MINIMIZING THE RISK OF MICRO EMBOLIZATION.

Minimizing the risk of thrombotic effect

When invisibility equals safety!

The Paclitaxel particle size matters!

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NO Paclitaxel debonding from the LEGFLOW bal-

loon surface before or during catheter DEB mani-

pulation.

NO PTX breaks from a brittle coating during bal-

loon inflation. The LEGFLOW PTX coating trans-

lates into a stable, smooth and elastic, balloon

surface.

NO thrombotic or embolic adverse effects caused

by large PTX crystals of 2.0-3.0µm adhering to the

vessel wall or caused by washed off PTX emboliza-

tion. LEGFLOW’s ‘SAFEPAX’ technology is based

on invisible nano crystalline PTX particles of only

0.1µm.

NO risk of PTX contamination of the cathlab envi-

ronment and personnel by detached and free PTX

crystals as LEGFLOW provides a stable PTX bal-

loon coating.

NO PTX-associated adverse effect potential

LEGFLOW’s ‘SAFEPAX’ coating controls the PTX

particle dimension, distribution and release.

NO hidden risk from the drug-release matrix: LEG-

FLOW ‘SAFEPAX’ consists of a novel and innovati-

ve Shellolic Ammonium salt composition.

NO uncontrolled and unpredictable drug wash-off

effect during balloon inflation and manipulation as

LEGFLOW’s moderate hydrophobic drug coating

limits PTX wash-off and ensures sufficient reprodu-

cible drug delivery to the lesion site.

NO DRUG COATING PITFALLS BUT ONLY HIGH PERFORMANCE. SUPERIOR PATIENT RESULTS.

For the safest SFA & BTK revascularization therapy.

More than 22.000 patientssuccessfully treated.

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A short-term balloon-to-vessel wall contact time of

90-120 sec. is sufficient to inhibit SMC proliferation

sustainably for up to 150 hours.

Pre-clinical results confirm no noticeable emboli-

zation results similar to POBA. Pre-clinical study

results confirm a most effective drug delivery into

the vascular tissue, showing a sustained drug ef-

fect of up to 28 days. ‘Cardionovum’s DEB shows

great effectiveness in neo-intimal growth reduction

in diseased vessels.’ *Source: Report on pre-clinical studies performed at CV-PATH Institute (R. Virmani MD), Gaithersburg USA

PROVEN !

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100

200

300

0.5 2 8 24 48 96 150Hours post dilatation

Pac

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el in

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conc

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/mg *

Preliminary results of the randomized RAPID trial

(LEGFLOW vs. POBA) reveal: LEGFLOW shows

greatest effectiveness in reducing neo-intimal hy-

perplasia also in high-risk patients with challenging

lesions.

The randomized European multi-center RAPID

clinical trial compares LEGFLOW Paclitaxel re-

leasing PTA balloon dilatation catheter with stent

placement vs. POBA with stent placement in the

treatment of extraordinary-long superficial femoral

artery (SFA) lesions of > 15 cm up to 25 cm length

and a total occlusion rate of 80%.

(Data on file at Cardionovum GmbH)

OPTIMAL THERAPEUTIC DRUG- IN-TISSUE BIOAVAILABILITY RESULTING

IN MAXIMAL CLINICAL EFFICACY.

LEGFLOW reliable performance even in long and occluded lesions.

LEGFLOW: No signs of vessel toxicity were found. No other safety concerns were noted in animals studied for up to 90 days.*

LEGFLOW RX/OTW®

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Case 1: Final resultCase 1: Pre-dilatation

SFA lesion 15 cm long with a 12 cm occlusion. Severe calcification.

Single shot of LEGFLOW balloon inflated at 16 atm.

More patient case reports and LEGFLOW

presentations at LINC (Leipzig Interventional

Course) + Veith Symposium New York, USA

available on file at Cardionovum GmbH.

Extraordinary SFA lesion length >15-25cm at high 80% occlusion rate results

in 95% patency and freedom of TLR.(Data on file at Cardionovum GmbH)

LEGFLOW RX/OTW®

PRELIMINARY RAPID STUDY RESULTS.

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Case 2: Final resultCase 2: Pre-dilatation

SFA lesion 15 cm long with a 6 cm occlusion length.

After LEGFLOW pre-dilatation optimal stenting result without residual stenosis.

HIGH CLINICAL EFFICACY. OUTSTANDING CLINICAL PERFORMANCE AND EXCELLENT LONG-TERM PATIENT RESULTS.

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Balloon length (mm) 4.0 mm 5.0 mm 6.0 mm 7.0 mm 8.0 mm 9.0 mm 10.0 mm

20 mmL 4.0-20 OTW

LS 4.0-20 OTWL 5.0-20 OTW

LS 5.0-20 OTWL 6.0-20 OTW

LS 6.0-20 OTWL 7.0-20 OTW

LS 7.0-20 OTWL 8.0-20 OTW

LS 8.0-20 OTWL 9.0-20 OTW

LS 9.0-20 OTWL 10.0-20 OTW

LS 10.0-20 OTW

40 mmL 4.0-40 OTW

LS 4.0-40 OTWL 5.0-40 OTW

LS 5.0-40 OTWL 6.0-40 OTW

LS 6.0-40 OTWL 7.0-40 OTW

LS 7.0-40 OTWL 8.0-40 OTW

LS 8.0-40 OTWL 9.0-40 OTW

LS 9.0-40 OTWL 10.0-40 OTW

LS 10.0-40 OTW

60 mmL 4.0-60 OTW

LS 4.0-60 OTWL 5.0-60 OTW

LS 5.0-60 OTWL 6.0-60 OTW

LS 6.0-60 OTWL 7.0-60 OTW

LS 7.0-60 OTWL 8.0-60 OTW

LS 8.0-60 OTWL 9.0-60 OTW

LS 9.0-60 OTWL 10.0-60 OTW

LS 10.0-60 OTW

80 mmL 4.0-80 OTW

LS 4.0-80 OTWL 5.0-80 OTW

LS 5.0-80 OTWL 6.0-80 OTW

LS 6.0-80 OTWL 7.0-80 OTW

LS 7.0-80 OTWL 8.0-80 OTW

LS 8.0-80 OTW- -

100 mmL 4.0-100 OTW

LS 4.0-100 OTWL 5.0-100 OTW

LS 5.0-100 OTWL 6.0-100 OTW

LS 6.0-100 OTWL 7.0-100 OTW

LS 7.0-100 OTWL 8.0-100 OTW

LS 8.0-100 OTW- -

120 mmL 4.0-120 OTW

LS 4.0-120 OTWL 5.0-120 OTW

LS 5.0-120 OTWL 6.0-120 OTW

LS 6.0-120 OTWL 7.0-120 OTW

LS 7.0-120 OTW- - -

150 mmL 4.0-150 OTW

LS 4.0-150 OTWL 5.0-150 OTW

LS 5.0-150 OTWL 6.0-150 OTW

LS 6.0-150 OTWL 7.0-150 OTW

LS 7.0-150 OTW- - -

Shaft material Polyamide

Balloon material Polyamide

Usable catheter length 135 cm or 80 cm (S)

Max. recommended guidewire 0.035"

Tip length 5.0 mm

Rated burst pressure

16 bar for Ø 4.0 Ø 5.0 - 6.0 mm (length ≤ 60 mm)14 bar for Ø 5.0 - 6.0 mm (length > 60 mm) Ø 7.0 - 8.0 mm (length ≤ 60 mm)12 bar for Ø 7.0 - 8.0 mm (length > 60 mm) Ø 9.0 - 10.0 mm

Introducer sheath size

5 F Ø 4.0 (length ≤ 60 mm)6 F Ø 4.0 (length > 60 mm)6 F Ø 5.0 to 6.0 mm7 F Ø 7.0 to 10.0 mm

Paclitaxel coating 3.0µg/mm²

S - ordersymbol 80 cm catheter length

Balloon Ø (mm) OTW 0.035“ Catheter length 800mm (LS) or 1350mm (L)

LEGFLOW OTW – 0.035“ Order information

LEGFLOW OTW – 0.035“ Technical data

THE WIDEST SELECTIONOF BALLOON SIZES.

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Balloon length (mm) 2.0 mm 2.5 mm 3.0 mm 3.5 mm 4.0 mm

20 mmL 2.0-20 RX

L 2.0-20 OTWL 2.5-20 RX

L 2.5-20 OTWL 3.0-20 RX

L 3.0-20 OTWL 3.5-20 RX

L 3.5-20 OTWL 4.0-20 RX

L 4.0-20 OTW

40 mmL 2.0-40 RX

L 2.0-40 OTWL 2.5-40 RX

L 2.5-40 OTWL 3.0-40 RX

L 3.0-40 OTWL 3.5-40 RX

L 3.5-40 OTWL 4.0-40 RX

60 mm L 2.0-60 RX L 2.5-60 RX L 3.0-60 RX L 3.5-60 RX -

80 mmL 2.0-80 RX

L 2.0-80 OTWL 2.5-80 RX

L 2.5-80 OTWL 3.0-80 RX

L 3.0-80 OTWL 3.5-80 RX

L 3.5-80 OTWL 4.0-80 RX

100 mm L 2.0-100 RX L 2.5-100 RX L 3.0-100 RX L 3.5-100 RX -

120 mmL 2.0-120 RX

L 2.0-120 OTWL 2.5-120 RX

L 2.5-120 OTWL 3.0-120 RX

L 3.0-120 OTWL 3.5-120 RX

L 3.5-120 OTWL 4.0-120 RX

150 mmL 2.0-150 RX

L 2.0-150 OTWL 2.5-150 RX

L 2.5-150 OTWL 3.0-150 RX

L 3.0-150 OTWL 3.5-150 RX

L 3.5-150 OTW-

200 mm L 2.0-200 RX L 2.5-200 RX - - -

Balloon Ø (mm) OTW 0.014“ Catheter length 1500 mm, RX 0.014“ Catheter length 1400 mm

LEGFLOW RX/OTW – 0.014“ Order information

OTW RX

Shaft material Polyamide Stainless steel

Balloon material Polyamide Polyamide

Usable catheter length 150 cm 140 cm

Max. recommended guidewire 0.014" 0.014“

Tip length 3.5 mm 3.5 mm

Rated burst pressure16 bar for Ø 2.0 - 2.5 mm14 bar for Ø 3.0 - 3.5 mm

16 bar for Ø 2.0 - 3.5 mm (length ≤ 40 mm) Ø 4.0 mm (length 20 mm)14 bar for Ø 2.0 - 3.5 mm (length > 40 mm) Ø 4.0 mm (length > 20 mm)

Introducer sheath size 4 F 4 F Ø 2.0 - 3.5 mm, 5 F Ø 4.0 mm

Paclitaxel coating 3.0µg/mm² 3.0µg/mm²

LEGFLOW RX/OTW – 0.014“ Technical data

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