LEGFLOW RX/OTW®

Paclitaxel Releasing Peripheral
Balloon Dilatation Catheter

LEGFLOW RX/OTW

For the safest SFA & BTK
revascularization therapy!

The LEGFLOW balloon drug coating quality is a major step beyond contemporary first and second generation DCB coatings.

The revolutionary efficacy in SFA and BTK revascularization!

LEGFLOW RX/OTW provides a 100% anti-proliferative vessel wall protection,
and promotes rapid healing after mechanical balloon angioplasty.

SFA

The best option for SFA/popliteal de novo and restenotic lesions.

Treating peripheral artery disease (PAD) in the superficial femoral artery (SFA) is a difficult challenge. The anatomy is very dynamic and contains complex lesions, but also patient comorbidities such as diabetes require the clinically most-effective therapy. The new LEGFLOW Paclitaxel-releasing peripheral balloon dilatation catheter provides a clinically most successful treatment of peripheral artery disease, and ensures a long-term vessel patency.

Please learn more about the excellent and clinically outstanding patient results, which are demonstrated and published by the RAPID Multi-center clinical study program.

RAPID trial
BTK

The new treatment of BTK lesions and critical limb ischemia! LEGFLOW shows promising early clinical study results.

The rate of recurrent stenosis after PTA and stenting is higher in the below-the-knee area than in femoropopliteal procedures. The absence of metal struts makes the LEGFLOW balloon dilatation suitable for treating long lesions, especially in small diameter vessels and areas in which flexion and compression of the stent may occur and result in stent fractures, particularly in the below-the-knee area. Thanks to the new stable ‘SAFEPAX’ PTX coating technology, the treatment of critical limb ischemia patients appears as safe as POBA angioplasty.

Clinical cases

Prohealing peripheral interventions with much less
restenosis. Successful treatment with anti-proliferative
vessel wall protection.

  • Conventional Mechanical Balloon Angioplasty
  • Trauma
  • Restenosis
  • Complications
  • Short- term Repeat Intervention
  • High Patient Cost
  • Angioplasty with Prohealing Local Drug Delivery
  • Trauma
  • Inhibition of Proliferation
  • Healing
  • Less Repeat Intervention
  • Health Care Saving

SAFEPAX. 0.1µm unsurpassed small PTX
particulates protect from micro-
embolization.

LEGFLOW ‘SAFEPAX’ technology utilizes the clinically important, stable nanocrystalline PTX drug coating. LEGFLOW ‘SAFEPAX’ coating is a step beyond contemporary first and second generation DCB coatings which had to compromise on vulnerable balloon coating mixtures out of a high water soluble drug excipient with relatively large PTX crystals.

Microscopy of the LEGFLOW DCB balloon surface
showing no visible PTX particulates

Minimizing the risk of microembolization.

The LEGFLOW ‘SAFEPAX’ drug coating technology provides a maximum protection from downstream micro-embolization effects to minimize the risk potential of any thrombotic event. The biological ’SAFEPAX’ drug release matrix avoids the side effects of plasticizer or contrast media drug excipients. Especially for the treatment of lower limb ischemia patients, the ‘SAFEPAX’ PTX drug coating of Legflow minimizes any undesirable risk of pro-thrombotic side effects, which might be associated with Paclitaxel.

‘Stable’ vs. ‘unstable’ DEB PTX coating

When invisibility equals safety!

1. LEGFLOW DCB PTX coating of non visibly small 0.1µm PTX particulates appear as safe as POBA.

2. Other DCBs with ‘unstable’ and brittle balloon coatings, consisting of large 2.0µm-3.0µm (visible) PTX crystals, bear a risk for the physician and patients.

About Safepax

No need of an extra insertion tool. The LEGFLOW coating integrity. A step beyond.

The indestructible, structural balloon coating integrity, combined with a protective drug coating finesse, does not require the use of an extra insertion tool.

The LEGFLOW Paclitaxel balloon surface coating cannot be wiped or fall off the balloon during catheter preparation, insertion or manipulation. LEGFLOW prevents endangerment of cathlab personnel, and guarantees a safe and predictable drug delivery to the target lesion site.

Proven! Optimal therapeutic drug-in-tissue bioavailability resulting
in maximal clinical efficacy.

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

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 embolization results similar to POBA. Pre-clinical study results confirm a most effective drug delivery into the vascular tissue, showing a sustained drug effect of up to 28 days. ‘Cardionovum’s DCB 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

LEGFLOW SAFEPAX performance. Effective DCB PTX drug-transfer.

Consistent and predictable drug delivery to the artery lesion site results in a homogenous and maximized drug absorption into the arterial tissue.

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 smallest PTX particulates leapfrogging ahead of 2.0-3.0µm large Paclitaxel crystals on most other DCBs.

The widest selection of balloon sizes on the market.
The best option for a successful treatment of any SFA and BTK indication.

Treatment of SFA:
4.0 mm - 10.0 mm balloon diameter
1350 mm catheter length

Treatment of BTK:
2.0 mm - 4.0 mm balloon diameter
1500 mm catheter length

Cardionovum clinical program of LEGFLOW Paclitaxel releasing peripheral balloon dilatation catheter.

1. RAPID. Randomized controlled multi center clinical study.
176 patients, Legflow vs POBA for pre-dilatation of SFA intermediate and long lesions, followed by stenting. Enrollment completed by January 15, 2016.

2. Magnificent randomized controlled multi center trial.
138 patients, Legflow vs POBA PTA with absence of binary restenosis. Enrollment startet.

3. Reflow. Multi center registry study.
120 patients, Legflow femoropopliteal long lesions vs POBA >15cm Tasc C&D. Enrollment startet.

4. Registry Randomized controlled single center clinical trial.
25 patients, efficacy of Legflow in infrapoliteal patients with CLI. Enrollment startet.

Successful LEGFLOW performance of patient life cases presented at LINC
(Leipzig Interventional Course) 2014/2015.

High clinical efficacy. Outstanding clinical performance and excellent long-term patient results. Literature available on file at Cardionovum.

Clinical cases