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Product Launches

APRIOMED | BOSTON SCIENTIFIC | CORDIS | COVIDIEN | HANSEN MEDICAL |  MEDTRONICTERARECONTERUMO |

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
Morrison Steerable Needle by AprioMed
 

Morrison Steerable FNA Needle
 
AprioMed’s Morrison Steerable NeedleTM is the first steerable fine-needle aspiration (FNA) needle enabling active guidance around objects inside the body. During image guidance, the needle can be steered with live feedback allowing precise needle placement. The 21-gauge FNA needle enables soft tissue biopsy as well as aspiration and injection. With the needle’s enhanced control it is possible to:
•    Make major adjustments around bones, organs or other structures
•    Make minor adjustments near target
•    Make multiple adjustments as the needle is advanced
 
 
BOSTON SCIENTIFIC
Boston Scientific releases new data and launches
next-generation Vessix™ Renal Denervation System at CIRSE 2014
 

Vessix™ Renal Denervation System
 
Boston Scientific announces release of latest data of REDUCE-HTN study* demonstrating a significant reduction in ambulatory and officebased blood pressure at 18 months in patients treated with the Vessix™ Renal Denervation System. This is one of the largest Renal Denervation data sets collected to date using ambulatory blood pressure monitoring. The data release coincides with the launch of the next generation 7F (2.67 mm) Vessix™ Reduce™ renal denervation system. “The Vessix System is the only technology designed to combine bipolar energy and a balloon-based platform, enabling consistent and complete renal denervation treatment across a variety of anatomies,” said Dierk Scheinert, MD, Director, Center of Vascular Medicine, Angiology & Vascular Surgery at Park Krankenhaus in Leipzig, Germany. “The new Vessix Reduce Catheter, Generator and Guide Sheath offer an outstanding operator experience and take what was already an exceptional system and make it even better.” 
* Schofer J, MD. REDUCE-HTN Clinical Study Interim12- and 18-month Data. Presented at EuroPCR; May 2014. All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. PI-256613-AA JUL2014
 
 
Cordis introduces SABER™ PTA Dilation Catheter
 

SABER™ PTA Dilatation Catheter
 
Developed to complement the Cordis Leg Solutions Portfolio as a next-generation, high-performance workhorse .018” PTA balloon, the SABER™ Balloon Catheter is approved to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries as well as for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Catheter is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature. 
The SABER™ Catheter is available in diameters of 2-10mm and lengths of 20-300mm. It combines a durable dual-layer hydrophilic coating with a low-profile body and new molded tip design to enhance crossability. In addition, this new Catheter has exceptional rated burst pressures – up to 18atm – and low compliance due to its construction with Cordis’ proprietary DURALYN® Balloon Material.
 
 
COVIDIEN
Trellis™ Peripheral Infusion System
 
Treatment for DVT Redesigned to Improve Thrombus Isolation, Lytic Drug Delivery
and Removal of Blood Clot
 
Post Thrombotic Syndrome (PTS) is a long-term effect of deep vein thrombosis (DVT). PTS occurs in almost half of patients within two years after DVT,1 and up to 33% of patients with PTS develop ulcers and skin deterioration.2 The Trellis™ system provides a way for physicians to dissolve acute thrombus and intervene on DVT1before it advances to PTS2. The system is composed of: an over-the-wire catheter with two occlusive balloons to close off the treatment area and block the release of the drug to other areas of the body.Compared to the previous version, the latest Trellis™ system features enhanced drug delivery a 129% larger aspiration window, which allows for better removal of the drug and the dispersed clot.
 
1 Kahn, S. et al. Determinants and Time Course of Postthrombotic Syndrome After Acute Deep Vein Thrombosis, Annals of Internal Medicine. 2008: 149: 698-707.2 
1 Kahn, S. et al. The post-thrombotic syndrome: current knowledge, controversies, and directions for future research, Blood Reviews. 2002; 155-165 doi: 10.1016/S0268-960X(02)00008-5
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. All claims and descriptions are for CE regulated countries. Availability of these products may vary in countries outside EU. ™ Trademark of a Covidien company.  
EU-14-0595-9
 
 
Emprint™ Ablation System and Emprint™ Procedure Planning:
The future of ablation from Covidien

 
Emprint™ ablation system

The Emprint™ ablation system with Thermosphere™  technology provides clinicians three kinds of spatial energy control – thermal, field and wavelength – to create predictable and spherical ablation zones regardless of target location, tissue type, or changes in tissue properties during a procedure1.
Come and learn more about the Emprint™  ablation system with Thermosphere™  technology and planning for powerful predictability at booth number 3,  at the symposium on Monday, September 15th  at 11.30, Auditorium 3 and in the Covidien learning center.
 
1: Covidien “In Vivo Performance Testing of the Emprint Microwave Ablation System in a Porcine Model” – R0043973 Rev A; Emprint Instructions for Use (IFU).
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. All claims and descriptions are for CE regulated countries. Availability of these products may vary in countries outside EU. COVIDIEN, COVIDIEN with logo and Covidien logo are US and internationally registered trademarks of Covidien AG. ™ Trademark of a Covidien company. EU-14-0595-10
 
 
 
Next generation of Onyx™ 34 liquid embolic system has received CE mark. 
 
 
In 2013 Covidien funded the project ORCA as an answer to a request from the market, that preferred a new formulation of PV Onyx™ liquid embolic systems, a formulation that gives less artifacts on CT scanning follow up. Artifacts on follow up CT scanning after treatment with PV Onyx™ liquid embolic system represent a challenge for the physician in identifying anatomical structures, especially after treatment of  Endoleaks Type I and II and large peripheral AVMs. The new formulation of Onyx™ 34L liquid embolic system has less streak artifacts on CT compared to the current version of Onyx™ liquid embolic system* 
*: CT artifact Validation in vitro using a water phantom tank to simulate body tissue and synthetic vessel Document TR_NV 11300 RevA  2013-08-20
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. All claims and descriptions are for CE regulated countries. Availability of these products may vary in countries outside EU. COVIDIEN, COVIDIEN with logo and Covidien logo are US and internationally registered trademarks of Covidien AG. ™ Trademark of a Covidien company. EU-14-0562- 15
 
 
Magellan™ Robotic Catheter 6Fr – 
Robotic Control in Smaller Vessels
 

The Magellan™ Robotic Catheter 6Fr extends the benefits of robotic precision, stability and control to peripheral vascular procedures in smaller vessels. Designed to deliver:
Independent control of dual bending sections
Lower profile and smaller diameter access site
Streamlined procedural workflow
Remote navigation, away from radiation
Discover the next big Intravascular thing at www.HansenMedical.com/StayAhead  
Visit booth #47 for a test drive. 
 
 
Introducing Kyphon® Express™ II System for Balloon Kyphoplasty
 
 
The newest generation, smaller profile system, that enables access to the entire spine, including higher thoracic regions
CONTROL:  Improved predetermined shape1
Designed with “less-compliant” material, the Kyphon® Express™ II Inflatable Bone Tamp (IBT) is less likely to enter the path of least resistance, offering more control during inflation.
STRENGTH: Increased structural integrity1
With strengthened bonds and modified shaft, the Kyphon® Express™ II IBT is able to achieve a pressure rating of 700psi.
PERFORMANCE: Potential to maintain height restoration2
The Kyphon® Express™ II IBT can resist PMMA-based cements’ chemical reaction, allowing one balloon to remain inflated during contralateral cement fill.
1. Compared to the Kyphon Express™ IBT. Data on file, Medtronic Inc.
2. Reduce IBT volume by 1.0cc. It’s recommended the balloon isn’t placed in contact with PMMA for more than 5 minutes. Refer to the the Kyphon Express™ II IBT IFU.
 
 
iNteract+
 
 
iNteract+ is TeraRecon’s new ‘ingeniously informed’ image viewer that works in combination with any of TeraRecon’s medical image viewers and image sharing and storage solutions to provide unmatched intelligence, powerful interoperability and simpliļ¬ed integration capabilities. 
iNteract+ solutions enhance the clinical end-user experience provided by PACS, VNA, EMR and other mission-critical image processing and image acqui-sition systems. Often, it can eliminate the need for many disparate image transport, viewing and storage systems while facilitating a smooth transition toward centralized administration of imaging resources.  From the sharing time-sensitive imaging data, to expanding the clinical tools available when and where physicians are working. iNteract+ stands alone as the only solution capable of also achieving collaborative remote access with image sharing, DICOM and non-DICOM viewing and incorporation of relevant clinical information all within one viewer.
 
 
AZUR® CX

AZUR® CX Peripheral Detachable Coil system
 
New! TERUMO is pleased to announce the launch of AZUR CX.  This soft .018” detachable coil has been optimized to deliver Best-in-Class, cross-sectional coverage.  It is a complex-shaped, bare platinum coil with an inner core of hydrogel that expands from the inside out.  The unique design creates a solid coil without any open spaces in the center.  The three-dimensional shape with variable diameter loops creates a stable anchor and promotes conformity to different morphologies.  
AZUR CX is excellent as a first coil – it provides a stable stopper for control in high flow areas and subsequent coil placement.  The detachment system delivers precise positioning and placement. By matching PROGREAT double marker with AZUR detachable coils, TERUMO Peripheral Coiling Solution offers you the precision of neuroradiology procedures in the peripheral vessels. 
 
 
TERUMO
PROGREAT® Double Marker

PROGREAT® Double Marker Micro Catheter system
 
New! TERUMO is pleased to announce the launch of PROGREAT double marker, available in 2.4Fr and 2.8Fr version. PROGREAT double marker has the unique navigability and torquability of the usual PROGREAT, plus two markers that provide excellent visibility. PROGREAT is now available in an extensive range, to allow a perfect match to your needs: PROGREAT 2.0Fr simple marker, PROGREAT 2.4Fr with double marker, PROGREAT 2.7Fr coaxial, PROGREAT 2.8Fr coaxial simple marker, PROGREAT 2.8Fr double marker. PROGREAT are available in 130cm or 150cm.
By matching PROGREAT double marker with AZUR detachable coils, TERUMO Peripheral Coiling Solution offers you the precision of neuroradiology procedures in the peripheral vessels.
 
 
TERUMO
MISAGO® 5mm
 
 
TERUMO extended the size mix of the MISAGO® SX stent system with a 5mm version for the treatment of fem-pop vessels. The clinically distinguished MISAGO Nitinol Stent Portfolio (6Fr, 0.035’’) has been expanded to include a 5mm diameter stent. Like the other sizes of the MISAGO stent, they offer optimal flexibility, long-term patency and excellent durability for femoral-popliteal lesions due to “spineless” stent architecture. The versatile Rapid Exchange delivery system with an ergonomic one-hand delivery handle can be used with short and with long wires to facilitate accurate and successful stent implantation. 
Features: MISAGO is available in stent diameters of 5.0-10.0 mm and lengths of 40-150 mm. Clinically proven patency rates, exceptional balance between flexibility and radial force, and the industry’s lowest fracture rates provide reliable clinical results. Three radiopaque gold-markers at each stent edge provide full deployment control and post-procedural visibility.
 
 
TERUMO
TERCROSS™
 
 
TERUMO introduces a new workhorse PTA Balloon (0.014’’, OTW) for BtK vessel treatment
TERCROSS is the name of TERUMO’s recently launched 0.014’’ OTW PTA-Balloon catheter that offers enhanced pushability, kink resistance and fast deflation time for BtK lesions due to extreme support of the OTW seamless polymer shaft. Available in a variety of broad sizes with long shaft design, TERCROSS enables the treatment of a wide range of BtK lesions. Additionally, TERCROSS has two crossing sizes of 1.25 and 1.5mm balloon diameters, designed specifically to facilitate the passage of extremely tight subocclusive lesions.
Features: TERCROSS is available in balloon diameters of 1.25-4.0mm and lengths of 20-200mm. The lowest balloon crossing profile and the hydrophilic coating provide reliable crossability. With an exceptionally high RBP of 20 atm. and fast deflation times it matches all requirements for an efficient and successful recanalization. Two different shaft lengths of 100 and 148cm enable antegrade and contralateral approaches. 
 
 
TERUMO
ROADSAVER®

The ROADSAVER® Carotid Artery Stent System for Sustained Embolic Protection
 
The ROADSAVER Carotid Artery Stent, a double layer micromesh stent is indicated for use in patients with carotid arterial atherosclerotic disease, by combining these unique features:
It is made of a dual-layer micromesh scaffold with the smallest cell size. The ROADSAVER is designed to sustain embolic protection, much like a metallic covered stent, allowing for side branch patency.
The braided Nitinol design allows the stent to adapt to most carotid anatomies.
The very flexible stent delivery system can recapture up to 50% deployment length and can be repositioned for accurate placement. Due to its flexibility the stent delivery system perfectly tracks through tortuous anatomies towards the lesions, minimizing the risk of access sheath/guide catheter dislodgement. 
These features set ROADSAVER apart as the latest technology and establish ROADSAVER as the next generation in carotid artery stents.