27

Product Lauches 2018

APRIOMED | AR BALTIC MEDICAL  | B.BRAUN |  BD | GUERBET TERUMO

The CIRSE Annual Meeting has become the number one platform for minimally invasive image-guided procedures worldwide. Every year, corporate key players in the field choose CIRSE to launch their innovative new products. Please find below information of this year’s product launches.

Please note that the information has been provided by the corporate partners and does not reflect the opinion of CIRSE nor does it engage our responsibility. CIRSE is not responsible for the published content or content published on any third party website.
 
 

APRIOMED 

Gangi-HydroGuard®

AprioMed introduces Gangi-HydroGuard®; an innovative tool for hydro-dissections. Gangi-HydroGuard® combines the well-known technique of a coaxial biopsy needle with an all new spring loaded blunt tip stylet providing extra control and safety during soft tissue biopsy. The hollow spring loaded blunt tip stylet:
• Offers the option to hydro-dissect while having a blunt tip in position
• Reduces risk of inadvertent perforation of adjacent tissue during coaxial needle advancement
• Enables penetration without exchange of stylets Gangi-HydroGuard® is available in two gauges (15G, 17G) and two lengths (12.1 cm, 17.1 cm) to better suite the requirements for your procedure.

We look forward to meeting you at Booth 68.

 
 
 
 
N-ELUTAX “3” ®
“Today the only available Drug coated Balloon in Europe for intra-cranial stenosis”

Intracranial atherosclerotic disease is a wellknown cause of ischemic stroke. Drug-coated balloons are commonly used in coronary and peripheral angioplasty. However, following the SAMMPRIS trial, medical treatment is favoured over stenting. A new treatment option is mandatory, therefore we developed N-ELUTAX “3” ®.

AR BALTIC MEDICAL TECHNOLOGY:
• Statistically significantly superior primary patency rate at 9 months compared to Wingspan-Stents (1).
• Proven consistent safety profile.
• Proprietary concept designed to treat and heal (as demonstrated through multiple clinical trials in peripheral and coronary lesions)

1) Gruber P, et al. J NeuroIntervent Surg 2018;0:1–5. doi:10.1136/neurintsurg-2017-013699

A pre-successor of N-ELUTAX “3” – based on the same catheter platform and coating is showing a significantly lower rate of ischemic re-events or restenosis in comparison with the WingspanStent-treated  patients for patients with symptomatic high-grade intracranial stenosis1. Restenosis was significantly lower (13% vs 64%).

 
 
 
B. BRAUN MELSUNGEN AG 
 
SeQuent® Please OTW 018: New low profile drug coated balloon

Low profile devices are more and more a relevant topic in the endovascular field when treating infrapopliteal and femoropopliteal lesions.

The new low profile drug coated balloon SeQuent® Please OTW 018 is the key for these target vessels. It enables the operator to use small sheath sizes of 4F/5F combined with a 0.018” guidewire. Additionally, the low profile Nitinol stent VascuFlex® 5F is available to treat femoropopliteal lesions in case scaffolding is needed.
This combination therapy with low profile devices provides the flexibility to treat above-the-knee lesions and below-the-knee lesions with proven state of the art technology and without changing the sheath and guidewire. Moreover, low profile devices are associated with a lower complication rate at the vascular access site.

SeQuent® Please OTW was already investigated in the CONSEQUENT randomized controlled trial.1 After 24 months the results of the 153 patients (1:1 DCB vs. POBA) with challenging femoropopliteal lesions (23.5 % with TASC C/D lesions, mean lesion length of 13.2 cm) demonstrated a significantly higher primary patency rate in the DCB group (72.3 vs. 48.4%, p = 0.006) with no further TLR after 14 months.
SeQuent® Please OTW 018 is available in diameters ranging from 2.0 mm to 6.0 mm and balloon lengths up to 120 mm. The VascuFlex® 5F portfolio consists of diameters ranging from 5.0 mm to 10.0 mm and stent lengths up to 200 mm.

1Albrecht T et al. Cardiovasc Intervent Radiol. 2018 Jul;41(7):1008-1014.



 
BD
 
LUTONIX® 014 BTK DCB – 4F

4F Sheath Compatible with GeoAlign
• Lower sheath profiles increase access site options, and may reduce the risk of access site complications.
• Now offering 4F sheath compatibility on all sizes for BTK including 2.0, 2.5, 3.0, 3.5, and 4.0mm diameters.
• The GeoAlign® Marking System simplifies repeat catheter placement, increases procedure efficiency and reduces radiation exposure by minimizing fluoroscopy time.

The First and Only BTK DCB in an Ongoing Real-World Registry and IDE Clinical Trial
• The Lutonix BTK Global Real-World Registry demonstrated promising results in a difficult patient population and has had zero re-interventions for distal embolization. The LUTONIX® 014 DCB1 delivered a 90.6% freedom from TLR rate and a 96.0% freedom from amputation rate at 6 months2.

Visit Booth #31 for more information

 
1 The LUTONIX® 014 DCB is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface  concentration of 2μg/mm2. Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions.
² LUTONIX® DCB BTK Registry Study 6 Month Outcomes. A Prospective, Multicenter, Single-Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA  catheter for Treatment of Below-the-Knee (BTK) Arteries. Interim data, site reported and subject to change. Data on file, BD Interventional, Inc.
 

 
BD
 
LUTONIX® 035 DCB – 220mm Lengths

Treat Longer Lesions with One DCB
• Longer length balloons may reduce costs and lower procedural time associated with using multiple DCBs in long lesions.
• Now offering longer lengths of 220mm in SFA sizes including 4, 5, 6 and 7mm diameters.

Top Tier Real World Registry Performance in Long Lesions
• The Lutonix SFA Global Real-World Registry demonstrated that long term results can be achieved even in long lesions. The LUTONIX® 035 DCB1 delivered an 88.2% long lesion freedom from TLR rate and a 76.7% freedom from safety composite rate at 24 months2.

Visit Booth #31 for more information

1 The LUTONIX® 035 DCB is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface concentration of 2μg/mm2. Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions.
2 Kaplan-Meier. Lutonix Global SFA Real World Registry, N=691. Primary efficacy endpoint is defined as freedom from TLR at 12 months. TLR free rate by subject counts at 12 months was 93.4% (605/648). The Kaplan-Meier TLR-Free survival estimate was 94.1% at 12 monthsand 90.3% at 24 months. Lutonix Global SFA Real-World Registry long lesion cohort was defined as lesions ≥140mm. Data on file, Bard Peripheral Vascular, Inc.

 

 
 
VECTORIO® mixing and injection System for cTACE Procedures

Vectorio® is a unique medical device set of resistant to Lipiodol® Ultra Fluid up to 24 hours.

It is dedicated to the mixing and delivery of Lipiodol® and anticancer drugs during conventional transarterial chemoembolization (cTACE). Vectorio® could help to standardize cTACE, standardization is a key parameter of cTACE. Designed in collaboration with interventional radiologists worldwide, including syringes, patented stopcock and sampling devices. Vectorio® is designed from Guerbet has obtained the CE mark for cTACE.

Advantages of the Vectorio® system – Prof Romaric Loffroy, Dijon, France “It is resistant to Lipiodol® up to 24 hours. The syringes of the kit are very well designed, making the mixing and injection easier and safer. The ingenious stopcock offers the opportunity to proceed with a new mixing during the intervention without disconnecting the microcatheter or the different syringes, thus optimising the safety and efficacy of mixture injection during chemoembolization.“

 
 
 
TERUMO 
 
Kanshas™ Drug Coated Balloon
 
TKanshas™ DCB can be expected to have an enhanced therapeutic effect due to Terumo’s proprietary uniform micro-crystal coating named Unicoat™. With that, Kanshas™ maintains a drug tissue residency for 90 days to limit neointimal proliferation.1 The product lineup includes a long balloon with a range up to 200 mm to treat long lesions that are common in the lower extremities, stated Terumo.
Kanshas™ is CE marked with the indication for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries.
 
1 Data on file at MicroVention