27

Product Launches

APRIOMED | C.R. BARD | CONTEGO | PHILIPS | SHOCKWAVE MEDICAL | 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-SoftGuard® coaxial biopsy needle​
 
 
AprioMed introduces Gangi-SoftGuard® coaxial biopsy needle.
 
Gangi-SoftGuard® 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 spring loaded blunt tip stylet: 
• Reduces risk of inadvertent perforation of adjacent tissue during coaxial needle advancement
• Provides visual feedback during procedure 
• Offers tactile response during procedure
• Enables penetration without exchange of stylets
 
Gangi-SoftGuard® is available in four gauges (12G, 13G, 15G, 17G) and three lengths (7.1 cm, 12.1 cm, 17.1 cm) to better suite the requirements for your biopsy procedure.
 
We look forward to meeting you at Booth 50.
 
 
C.R. BARD
Designed for Maximized Success
 
 
The  Marking System, A Bard Technology
 
The  Marking System on the Lutonix® 035 DCB is designed to facilitate repeatable catheter alignment at the lesion¹,² and to increase procedure efficiency by minimizing fluoroscopy exposure³,²
 
Lutonix® 035 DCB – Maximize SFA Outcomes
 
• Demonstrated a statistically significantly superior primary patency rate at 12 months compared to PTA⁴
• Demonstrated a safety profile consistentwith PTA⁴
• Unique, proprietary formulation designed to maximize efficacy without compromising safety (as demonstrated through rigorouslydesigned clinical trials)
 
¹ The Lutonix® 035 DCB should extend a minimum of 5 mm proximally and distally from the lesion and injury segment
² When the catheter is exposed to the vascular system, the location of the balloon should be confirmed while under high quality fluoroscopic observation.
³ Animal study (repeat PTA in swine artery) performed by 3 physicians who tested the Lutonix® 035 DCB (no drug) and the ULTRAVERSE® 035 PTA Catheter, both with GeoAlign® Markers, to POBA with no GeoAlign® Markers (n=112, test n = 96, control n = 16). Animal data on file, Bard Peripheral Vascular, Inc., Tempe, AZ. Animal test results may not be indicative of clinical performance. Different test methods may yield different results. 
⁴ LEVANT 2 clinical trial data on file. N=476. At 12 months, treatment with Lutonix® 035 resulted in a primary patency rate of 73.5% versus 56.8% with PTA alone (p=0.001). Primary patency defined as absence of binary restenosis defined by DUS PSVR >2.5 and freedom from Target Lesion Revascularization (TLR). At 12 months, treatment with Lutonix® 035 resulted in a freedom from primary safety event rate of 86.7% versus 81.5% with PTA alone. Primary safety defined as composite of freedom from all-cause Perioperative death and freedom at 1 year in the index limb from Amputation (ATK or BTK), reintervention, and Index-limb related death. Percentages reported are derived from Kaplan-Meier analyses, (not pre-specified).
 
 
Paladin® Carotid Post-Dilation Balloon with Integrated Embolic Protection
 
 
The Paladin carotid post-dilation balloon with integrated embolic protection system combines a percutaneous angioplasty balloon with an integrated embolic protection on the same catheter. This combination design creates filter protection during balloon dilatation and post dilation without adding extra procedural steps or catheter exchanges. 
 
The filter comes in a baseline collapsed state and does not require unsheathing, it has 40-µm pores to capture particles. It is the only filter in which the physician can adjust the size of the filter to match patient anatomy eliminating the need to guess the size of the vessel which allows for complete filter apposition to the vessel wall.
 
The Paladin system has received CE Mark approval and is currently available for commercial distribution in Europe.
 
 
PHILIPS
Philips launches the next generation of OncoSuite: Open Trajectory liver-centric imaging; Wiper Movement for one-click DualPhase acquisitions; Dedicated LUMI Imaging Protocols for Radiopaque Beads*.
 
 
At CIRSE 2016, Philips introduces the next generation of OncoSuite, featuring AlluraClarity FD20, to decide, guide and confirm interventional oncologic treatments of the liver.
 
In OncoSuite, high-resolution multiple lesion detection with the display of tumor feeding vessels in a single DualView is provided by XperCT Dual, the next evolution of XperCT. Its Wiper Movement allows one-click DualPhase acquisitions to visualize arterial and post-arterial (delayed) phases of contrast injection. This automatic dual phased imaging can be customized with a user-defined delay interval providing superb insights into perfusion dynamics at tableside.
 
The novel Open Trajectory or ‘open arccone beam CT’ is Philips’ latest XperCT Dual acquisition technique. Traditional geometric movement of the C-arm centers the field of view (FOV) on the spine leaving the liver periphery potentially out of sight. Open Trajectory moves beyond this limitation by following liver-centered 3D imaging helping the physician visualize and detect also peripheral liver lesions1. In collaboration with BTG Interventional Medicine, XperCT Dual offers optimized LUMI imaging protocols to be applied with radiopaque embolic beads*. These support visual precision delivery of the radiopaque beads for enhanced procedural control and end point determination.
 
1 Schernthaner R et al. Radiology. 2015 Dec; 277(3):833-41
* LC Bead LUMITM is a BTG Interventional Medicine Product, which is ONLY cleared for sale and distribution in the USA.
OncoSuite: Live Image Guidance with XperCT Dual and EmboGuide
 
 
Peripheral Lithoplasty® System​
 
 
Leave nothing behind in calcified stenotic lesions1
 
•    1% stent rate in moderate to severe calcification 
•    3.0 mm acute luminal gain
•    23.8% average post-procedure residual stenosis
 
The Peripheral Lithoplasty System 
•    combines the calcium disrupting power of lithotripsy with the familiarity and simplicity of a balloon in a single enabling device.
•    utilizes low-pressure lithotripsy-enabled angioplasty — a therapy which can disrupt and restructure superficial and deep calcium improving tissue flexibility and opening the door to new treatment options.  
 
Our unique Lithoplasty Technology is designed to change the standard of care for advanced cardiovascular disease by directly addressing a common obstacle in effective treatment of advanced disease: calcified plaque.  Experience the power of Lithoplasty Technology for the treatment of calcified, stenotic peripheral arteries.
1.  Pooled DISRUPT PAD Study
 
Shockwave Medical Symposium
Monday, September 12, 2016 at 14:30-15:30 in Room 114
 
www.shockwavemedical.com
CIRSE 2016. For use outside of the US only.
 
 
Azur CX35​

AZUR CX35 Peripheral Coil System introduces a new and unique concept: the first and only peripheral HydroCoil with cross-sectional coverage and the benefits of patented hydrogel technology, allowing easy control in high-flow areas.
 
By matching the Progreat double marker with AZUR detachable coils, the Terumo peripheral coiling solution offers interventional radiologists the precision of neuroradiology procedures in peripheral vessels.
 
 
Guide Wire GT 14”​
 
 
Radifocus Guidewire GT now available as 0.014" (0.36mm) diameter! 
With the launch of the Radifocus Guidewire GT, Terumo brings now to you a full range of diameters to use in super-selective applications.
 
Distal Selectivity
Available in a variety of tip angles (45°, 90°, double angle 90° + 150°), the Terumo Radifocus Guide Wire GT is the ideal solution for precise and rapid vessel selection even in the most challenging and angulated anatomies.
 
Outstanding Torque Control
The super-elastic nitinol core means that the possibility of kinking is reduced to a minimum and it also allows for easy maneuverability. Indeed, the Radifocus Guide Wire GT’s exceptional levels of torque responsiveness offer substantial control through even very difficult angulated anatomies thanks to the one-piece construction of the wire.
 
Extremely Flexible Tip
The Radifocus Guide Wire GT was developed with a flexible distal tip to enable smooth navigation through tortuous and difficult vessel structures. The flexibility was realized by creating extra-long tapers at the tip.The Radifocus Guide Wire GT is available in either a standard, flexible length (25 cm for 0.012"/0.31 mm & 0.014"/0.36mm diameter) or a floppy length (35 cm for 0.016"/0.41 mm diameter).
 
Excellent Visibility
The Gold Coil (2 cm in length) found at the tip of the Radifocus Guide Wire GT ensures excellent radio-opacity even in the smallest and most distal vessels.
 
 
Metacross​

Metacross is a percutaneous transluminal angioplasty (PTA) balloon dilatation catheter for peripheral indications.
 
Metacross RX (rapid exchange) is the perfect match for the Misago RX self-expanding peripheral stent, combining safety, simplicity and effectiveness.1
 
1 Safety defined as low incidence of complications (included low fracture rate not correlated with a vascular event). Schulte et al. Misago
2: One year outcomes after implantation of the Misago Self-Expanding nitinol stent in the superficial femoral and popliteal artery of 744 patients. Journal of endovascular therapy 2012: 19: 744-784.