Product Launches at CIRSE 2011
Showing once again that the CIRSE Annual Meeting has become the number one platform for minimally-invasive image-guided procedures in Europe, numerous companies chose CIRSE 2011 to launch their innovative new products.
Abbott Vascular | Art Ventive | Asahi Intecc | Bard | Biotronik | Boston Scientific | CID Vascular | Cook Medical | Delcath | Eurocor | EV3 | IDEV Technologies | Medrad | Medtronic | Merit Medical | Optimed | Philips | Simbionix | Synthes | Terumo | Vidacare
ABBOTT VASCULAR www.abbottvascular.com
• Armada 35 and Armada 35 LL PTA Balloon Dilatation Catheters
Abbott Vascular, a global leader in endovascular care, announced the introduction in Europe of the Armada 35 and Armada 35 LL PTA Balloon Dilatation Catheters, the newest technology platform for opening blockages in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries. Armada 35 is the second product offered in our Armada balloon family and is available in lengths up to 250 mm and diameters up to 14 mm, enabling physicians to treat a broad range of lesions. Armada's advanced design incorporates multi-layer CrossFlex2 balloon technology, which provides low profiles, flexibility, and higher rated burst pressures. Armada 35 and Armada 35 LL are built to provide optimal performance to help streamline procedures from start to finish. The introduction of the Armada 35 and Armada 35 LL PTA Balloon Dilatation Catheters demonstrates Abbott's continued commitment to providing innovative endovascular products to meet physician needs and potentially improve patient outcomes.
• Xpert Pro Self Expanding Stent System
Abbott Vascular, a global leader in endovascular care, announced the introduction of the Xpert Pro Self Expanding Stent System for the treatment of peripheral artery lesions. The next-generation Xpert Pro features an innovative, tri-layer catheter design which includes an advanced stabilizer coil that allows precise stent deployment and placement and a slim, intra-laced outer sheath that improves deliverability and access for tight anatomies. Xpert Pro also has customized stent designs for each vessel diameter with thinner struts in small vessels to minimize vessel lumen reduction. Xpert Pro provides longer stent lengths up to 100mm and diameters as small as 3mm – making it an optimal choice for treating a wide range of below-the-knee (BTK) lesions. The introduction of the Xpert Pro Self Expanding Stent System further expands Abbott's BTK and SFA product portfolios.
ART VENTIVE www.artventivemedical.com
• ArtVentive Endoluminal Occlusion System (EOS)
The official launch of the ArtVentive EOS device is planned at CIRSE 2011.
Significant new information has become available due to completed First in Human Clinical studies. The Endoluminal Occlusion System is intended for arterial and venous embolization in the peripheral vasculature.
The EOS device has been developed for percutaneous occlusion of the peripheral arterial and venous vasculature. The system is comprised of an implantable occlusion device and a delivery catheter. The implant is available in variety of sizes to accommodate the human peripheral vasculature, with the delivery system being pre-loaded with the implant, sterile and ready to use.
ASAHI INTECC www.asahi-intecc.com
Smooth navigation to distal vessels with smaller profile microcatheter – Asahi Intecc introduces the next generation of Stide microcatheter, Stridesmooth+. This super-selective microcatheter has a smaller profile and a larger inner diameter, compared to the Stride 2.2Fr microcatheter. This enables easier access to distal vessels even in a very tortuous anatomy and quicker delivery of microspheres or other embolic materials. For more information, please visit our booth #136 on the entrance level.
Contact: Asahi Intecc Co., Ltd. Europe Office / Strawinskylaan 967, WTC Tower D – 9th floor, 1077XX Amsterdam, The Netherlands / Phone: +31 20 794 0642 / Fax: +31 20 794 0641 / URL: http://www.asahi-intecc.com / Email: email@example.com
• CROSSER® CTO Recanalization Catheter
Over the Wire and Rapid Exchange CROSSER Catheters are delivered over standard guidewires and utilize high frequency, mechanical vibrations against a CTO cap at 20,000 Hz, opening a micro channel within a portion of the CTO by mechanical impact allowing for subsequent PTA, Atherectomy and/or stent placement. Crosser is offered on .014” and .018” platform compatibility with both peripheral and coronary indications. The device is easy to set up and lesions can typically be crossed in less than 10 minutes safely and effectively. Crosser enables central luminal crossing across all vascular beds and is the only device designed for BTK *Frontline Therapy *Enables Central Lumen Crossing *Maximizes Therapeutic Options
• LifeStent® 200 mm
Treat Long SFA & Proximal Popliteal Lesions with the LifeStent® Vascular Stent Single Stent Treatment Strategy Enabled with NEW 200 mm Length Improved Trackability and Deployment Force with NEW Multi-Functional Catheter System LifeStent® is a self-expandable nitinol stent with multi-dimensional helical architecture designed to treat long SFA and proximal popliteal lesions, allowing a single stent strategy with stents up to 200mm long. LifeStent® is designed to meet the challenges of the SFA anatomy through instantaneous and dynamic conformability and radial strength enabling to treat high % stenoses. The new delivery system is designed for enhanced placement accuracy, improved trackability and deployment force. The RESILIENT data show improved patency, improved freedom of TLR, and low fracture rates.
• SEEKER™ Crossing Support Catheter
A Marked Improvement in Crossing – A New Measure of Performance The SEEKER™ Support Catheter expands treatment possibilities by combining unique lesion measurement capabilities with exceptional pushability and a lop tip entry profile. *Lowest Tip Entry Profile Available *Unmatched Radiopaque Marking System
• Passeo-14 infrapopliteal PTA catheter
Developed by experts, for experts.
BIOTRONIK is committed to developing state of the art medical devices for minimally invasive vascular intervention. The introduction of Passeo-14 represents the next level of this commitment- conceived and developed through consultation with global experts in infrapopliteal angioplasty and utilizing BIOTRONIK’s profound technological competence.
Passeo-14’s unique design features seek to address weaknesses common to current infrapopliteal PTA catheters:
· Stiffened proximal catheter shaft and hydrophilic balloon coating ensure excellent push transmission and easy lesion crossing.
· Variable, diameter specific, distal shaft length means flexibility is optimized.
· Fast balloon deflation and lengths up to 220mm may reduce procedure times.
Combine these features with a wide portfolio, including dedicated inframalleolar sizes and it’s easy to see why Passeo-14 is so eagerly anticipated.
Passeo-14 is the latest addition to BIOTRONIK’s comprehensive and unique portfolio.
4F Solutions: Minimal is optimal.
BOSTON SCIENTIFIC www.bostonscientific.com
• OffRoad™ Re-entry Catheter System and TruePath™ CTO Device
Familiar tools. Familiar feel.
Boston Scientific is proud to present two new additions to facilitate the treatment of chronic total occlusions, designed to be intuitive, easy to handle, they are based on tools familiar to the interventionalist and offer a choice of either subintimal re-entry or intraluminal crossing of the CTO.
OffRoad™ is an elegant and simple dual-component solution for challenging lesions. Re-entry is intuitive as the 5.4 mm articulating positioning balloon, tracks over the existing 0.035” (0.89 mm) guidewire and then directs the system, creating a path for the micro-catheter lancet to re-enter the vessel.
TruePath™ is a powerful new solution for intraluminal treatment of chronic total occlusions. Guidewire-like design with a diamond coated rotating tip is nearly half the size of some competitive offerings, to facilitate steering and enhance crossing lesions. Once positioned the self-rotating tip works effortlessly to power across the occlusion.
*OffRoad™ and TruePath™ are pending CE Mark, not available for sale in the European Economic Area (EEA)
• Interlock™-35 Fibered IDC™ Occlusion System
Accuracy, Power and Precision
Boston Scientific is pleased to announce a new addition to its detachable coil family, Interlock™-35.
Interlock™-35 has been designed for deployment accuracy; its interlocking design offers physicians control, precision, and retractability. It is fibered along the entire length with highly thrombogenic Dacron fibers and exists in long coil length allowing for fast and effective vessel occlusion.
Interlock™-35 utilizes 5Fr Imager™ II (0.035 and 0.038) catheters. Interlock™-35 comes in a broad matrix - large diameters, long lengths, and three coil shapes:
- 2D: Anchorability results from the helical shape of the coil in constant, consistent contact with the wall of the vessel
- Diamond: Occlusive Power is obtained by tapering the proximal and distal coil diameters, maximizing cross–sectional flow disruption.
- Cube: Three-Dimensional design allows for circumferential wall apposition and packability in visceral aneurysms.
making it the right tool for a variety of procedures.
• Mustang™ and Coyote™¹ Balloon Dilatation Catheters
Excellence on every dimension
Boston Scientific is proud to announce two new additions to its PTA Balloon family, Mustang™ and Coyote™ Balloon Dilation Catheters
Both balloons are based on Boston Scientific’s new NyBax™ Balloon Material, a proprietary co-extrusion of Nylon and Pebax™ polymers engineered to provide high-pressure dilatation in a highly deliverable low-profile balloon.
Mustang™ is a highly deliverable 0.035” (0.89mm) guidewire compatible PTA balloon that offers excellent rated burst pressure (up to 24 ATM / 2432kPa) and is the only 7 x 200 mm balloon compatible with a 5 F (1.67mm) introducer sheath. Available in 203 sizes, it provides the broadest matrix of any available peripheral balloon.
Coyote™ is an ultra low profile 0.014” (0.36mm)² guidewire compatible PTA Balloon that meets the challenges of BTK interventions, with a 0.017”(0.43mm)² lesion entry profile and a 0.031” (0.79mm)² crossing profile combined with great trackability, pushability and excellent deflation rates, Coyote™ is the PTA Balloon to get you to, through and treating BTK Lesions
¹ Coyote™ Balloon Dilation Catheter is pending CE mark, not available for sale in the EEA
² Average measurements taken by Boston Scientific (n=3) on 2x120mm balloons. Data on file. Bench testing may not be representative of clinical performance.
CID VASCULAR www.cidvascular.com
• EASY FLYPE & EASY HIFLYPE self-expandable stent.
CID (Carbostent and Implantable Device) has recently launched the EASY FLYPE & EASY HIFLYPE self-expandable stent.
With this new products CID introduces, on its Nitinol Stent family, the iCarbofilmTM, who allows a further increase in density of pure Carbon while reducing it’s overall thickness to <0.3?m. This innovative technology brings an even closer similarity to the diamond structure of pure Carbon and its exceptional bio/haemo compatibility.
The new Easy Flype and Easy HiFlype delivery system guarantees:
• Easy track and reliable lesion crossing. Provided by the use of flat-wire braiding which optimizes push/flex performance of the catheter shaft, also in cross-over procedures.
• Smooth device release thanks to the PTFE coated and braided catheter which minimizes friction between components, increasing flexibility and reducing the risk of kinking.
• Precise positioning. The 3:1 gear reduction allows micrometric release and sure anchoring of the stent to the vessel wall.
For more information please visit: www.cidvascular.com
COOK MEDICAL www.cookmedical.com
• Micropuncture® Pedal Access Set
Infrapopliteal occlusions in patients with critical limb ischemia (CLI) are a challenge. A new revascularisation technique—the retrograde approach—aims to give physicians another chance at limb salvage. Cook Medical is providing expanded access options with the first dedicated pedal artery access set.
The dedicated Micropuncture Pedal Access Set from Cook consists of a 21-gage, 4 cm echogenic needle; a 7 cm Micropuncture introducer engineered to increase control while gaining retrograde infrapopliteal access; and a .018 inch nitinol wire guide and hemostasis valve. This Check-Flo® hemostasis valve attaches directly to the Micropuncture introducer, allowing it to be used as an interventional introducer with a 2.9 Fr inner diameter.
Complementary technologies from Cook—the Approach® CTO Microwire Guide, Approach® Hydro ST Microwire Guide and 2.6 Fr CXI™ Support Catheter—allow completion of the infrapopliteal retrograde approach. (Not all products may be approved for sale in all regulatory jurisdictions.)
• Zilver® Vena™ Venous Self-Expanding Stent
The Zilver Vena Venous Self-Expanding Stent is the only stent designed specifically to meet the challenges of iliofemoral venous stenting.
With this groundbreaking new product, Cook has managed to provide strong radial force from end to end as well as the flexibility and kink resistance of proven Zilver technology. Zilver Vena is compatible with 7.0 Fr sheaths/9.0 Fr guiding catheters and is deployed via 80 and 120 cm delivery systems. Four gold markers feature on each end. The stent is preloaded in a Flexor® introducer.
The Zilver Vena stent has no clinically significant stent foreshortening and is available in 14 and 16 mm diameters and 60, 100 and 140 mm lengths.
This flexible, self-expanding nitinol stent is the only product indicated to treat symptomatic venous outflow obstruction in the iliofemoral veins. (Not all products may be approved for sale in all regulatory jurisdictions.)
• CHEMOSAT® delivery system
Our proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. Our initial focus is on the treatment of primary and metastatic liver cancers. In 2010, we concluded a Phase III metastatic melanoma study, and recently completed a multi-arm Phase II trial to treat other liver cancers. We received CE Mark approval for the Hepatic CHEMOSAT® delivery system in April 2011, and expect to file for FDA approval of our system in the United States by the end of 2011.
• FREEWAY™ 035 PTA drug-eluting balloon
Eurocor, a European Life Sciences Technology Corporation specialized in the research, development and manufacturing of cardiovascular and endovascular products, announces the launch of FREEWAY™ 035, the latest paclitaxel-eluting PTA balloon catheter technology. This new DEB catheter is especially designed to treat atherosclerosis in peripheral arteries e.g. superficial femoral arteries (SFA). Eurocor’s DEB technology utilises a 1:1 shellac/paclitaxel coating, which is released when the balloon is expanded. In addition to the FREEWAY™ 035 balloon line Eurocor offers a full dedicated product line for below the knee artery treatment, FREEWAY™ 014 for the treatment of patients with Critical Limb Ischemia (CLI).
Early clinical experiences suggest that the technique reduces rates of restenosis in patients undergoing angioplasty in femoropopliteal arteries and arteries below-the knee, with no additional adverse events. Three randomized prospective clinical trials initiated for FREEWAY™ drug-eluting balloon have already entered into their critical phase.
• DURABILITY 200: More Clinical Evidence for 200mm Stents in the SFA
Drs. Bosiers, Deloose and Peeters implanted 200mm Protégé™ EverFlex™ stents (ev3 Inc., Plymouth, USA) in TASC C-D femoropopliteal lesions over 150mm long in 100 Rutherford 2-5 patients. Primary endpoint was primary patency at 12 months by DUS (PSVR < 2.4).
Per patient 1.6 200mm Protégé™ EverFlex™ stents were implanted. Mean lesion length was 242mm (160-450mm). At 12 months: primary patency was 64.8%, freedom from TLR was 68.2%, ABI and Rutherford class improved significantly (p < .0001), stent fracture rate was 6.0% per patient with only one loss of primary patency.
The authors concluded: “The DURABILITY 200 results show an acceptable primary patency rate in TASC C and D lesions, the findings warrant further investigation. The release of more SFA stent data will increase our understanding of the effect of stent design”.
Published online in June 2011 in the Journal of Vascular Surgery.
For more information, visit the ev3 – Covidien booth at CIRSE.
IDEV TECHNOLOGIES www.idevmd.com
• SUPERA VERITAS® Peripheral Vascular System
SUPERA VERITAS® Peripheral Vascular System - NOW AVAILABLE in 6Fr!
The new lower profile delivery system offers physicians more treatment options, easier operation, and greater delivery control, while providing the unique strength, flexibility, and performance benefits of the SUPERA stent. The 6Fr size allows a smaller access site and multiple approach options when treating patients with peripheral artery disease (PAD), which can be particularly important when treating stenoses or occlusions in the superficial femoral artery (SFA) and the popliteal artery. In addition to having a lower entry profile, the new 6Fr system is available in two catheter lengths, 80 cm and 120 cm, and offers even better efficiency and trackability.
Contact: IDEV Technologies, BV • Kapershof 46, JS Beuningen 6641, The Netherlands
Phone +31.24.675.4030 • Fax +31.24.675.4061 • www.idevmd.com
The Cotavance® drug eluting balloon, developed by MEDRAD, INC., a global interventional business of Bayer HealthCare, is the first and only peripheral drug eluting balloon with Paccocath® Technology, a proprietary drug matrix applied to the balloon of an angioplasty catheter for the treatment of narrowed blood vessels associated with PAD.
Paccocath technology is the most studied, proven, and published DEB technology. Positive long-term clinical results from the THUNDER and FEMPAC studies show that interventional procedures using Paccocath technology keep vessels open wider over time compared to standard angioplasty and published reports of other current standard-of-care therapies. Patients treated with Cotavance DEB experience durable outcomes characterized by lower restenosis rates and improved quality of life.
MERIT MEDICAL www.meritmedical.com
• Laureate Hydrophilic Guide Wire
Finally, a hydrophilic guide wire with TRUE one-to-one torque and lasting lubricity! Merit Medical proudly introduces the Merit Laureate® Hydrophilic Guide wire.
Clear clinical benefits:
· Exceptional one- to- one torque ratio
· Rapid vessel selection
· Enhanced lesion cross-ability
· Longer lasting lubricity
Join us at booth #128 for a hands-on comparative demonstration of this exciting new hydrophilic guide wire!
A New Era in Hydrophilic Guide Wires
• Kyphon® Xpede™ Bone Cement
Medtronic presents the new Kyphon® Xpede™ Bone Cement. This cement is indicated for the treatment of pathological fractures of the vertebral body. It is designed to meet the specific needs of the minimally-invasive Kyphon® Balloon Kyphoplasty procedure, doughing quickly, yet giving the physician sufficient time for careful, surgical introduction and controlled delivery.
Kyphon® Xpede™ Bone Cement is more than twice as quick to dough compared to Kyphon® HV-R® Bone Cement, giving the physician the ability to help more patients faster. Kyphon® Xpede™ Bone Cement enables easier intra-operative planning and helps physicians gain time in their procedures. Plus, Kyphon® Xpede™ Bone Cement provides all of the great handling characteristics our customers have grown to expect from Medtronic, the inventor of balloon kyphoplasty.
Our best 6F stent system ever.
The unique micro-mesh design for excellent vessel wall coverage in combination with elaborate electro-polishing into the farthest corners makes this nitinol stent truly unique in comparison existing stent on the market. The smooth finish of the stent surface with perfectly rounded corners reduces reactions and irritations of the intima and rendering the structure extreme durable. sinus-SuperFlex-635 guarantees both optimal vessel adaptation and maximal flexibility without compromising radial force. The stent ends with closed-cell design and radiopaque markers ensure excellent visibility facilitating vessel wall fixation. Its well proven 6F application system, with 1:1 rotational control allowing pin-point placement, is tapered to an .035i guide wire, and is ideally suitable for cross-over technique.
The new semi-compliant PTA-balloon catheter offering 5F sheath compatibility. The low profile tip design, the radiopaque markers and the durable nylon balloon enable a safe and easy use for the interventionalist.
All parts, from tip to hub, are perfectly matched together and achieve the highest scores in inflation-deflation times, rated burst pressure, rotational control and kink resistance.
Tapered to an .035i guide wire the balloon catheter offers excellent torque control and passage through extreme, calcified stenoses or occlusions. The re-wrapping feature of the balloon facilitates re-entry of the catheter and multiple inflations. The NyloTrack-35 sets new standards in balloon dilatation.
• Sonalleve MR-HIFU
Philips to launch a new application for Sonalleve MR-HIFU therapy platform during CIRSE 2011
At CIRSE 2011, Philips is introducing a new therapy application for its Sonalleve MR-HIFU* therapy platform, specifically for the palliative pain treatment of bone metastases. The Sonalleve MR-HIFU therapy platform was first launched to offer a non-invasive alternative to traditional surgical treatments for uterine fibroids. It combines magnetic resonance (MR) imaging with high-intensity focused ultrasound (HIFU) therapy. This treatment technique minimizes patient discomfort.
Many cancer patients develop metastases in the bones at the latter stages of their disease, which can cause severe pain. Sonalleve MR-HIFU is now introducing a palliative pain treatment of bone metastases, and offers a non-invasive alternative to traditional treatments. Broader coverage and easier patient workflow solutions have also been added to the MR-HIFU platform. See a demonstration at Philips booth, 111.
* Not available for sale in North America
• EVAR software module on PROcedure Rehearsal Studio
The new EVAR software module on the PROcedure Rehearsal Studio allows clinicians to create a patient specific 3D anatomical model based on a patient’s CT for the purpose of simulating, analyzing and evaluating preoperative endovascular abdominal aortic aneurysm repair for surgical treatment options. The generated 3D model is loaded onto the Simbionix ANGIO Mentor to allow physicians to practice using a stent graft system including aortography, precise deployment of the bifurcated and contralateral leg stent graftcomponents, deployment of iliac and aortic extensions and touch-up ballooning.
Simbionix is the world’s leading provider of simulation, training and education solutions for medical professionals and the healthcare industry.
With its full array of MIS simulators, PROcedure Rehearsal Studio, MentorLearn Simulator Training Management, and online Simposia Clinical Practice Communities, the company is committed to advancing clinical preformance and optimizing procedural outcomes through education and collaboration.
• Stentoplasty with the Vertebral Body Stenting (VBS) System
A reconstructive and height conserving percutaneous procedure.
The VBS stents are introduced percutaneously into the vertebral body and inflated under controlled balloon dilatation. The Vertebral Body Stenting technology has an expansion ratio up to 400% and represents therefore a nice alternative for the reconstruction of collapsed vertebrae. The mechanical construct conserves the height after balloon deflation while at the same time offering a cavity for injection of highly viscous PMMA bone cement for vertebroplasty or Kyphoplasty. VBS is a safe and minimally invasive treatment method for painful vertebral body fractures and lesions. It helps to prevent effects such as postural damage and pain caused by postural kyphosis.
• Misago® now available in 4 new sizes
Terumo has now expanded the range of its Misago RX 0.035" self-expanding stent to include the following new sizes: 6x120 mm , 6x150 mm , 7x120 mm , 7x150 mm. The Misago unique rapid exchange delivery mechanism provides precise stent deployment even in longer stents. The reliable long-term safety and efficacy of the MIsago stent, which have been proven in current clinical studies, are now available in sizes to treat extra-long lesions.
Terumo launches Senri®, a new low profile balloon catheter
Terumo is proud to announce the launch of Senri, a 0.018" RX low profile PTA balloon catheter. The new product is available in 3 to 8 mm balloon diameters intended to cover the entire lower limb area. This product is recommended as a daily workhorse due to its balanced overall performance and reliable Japanese quality. Senri has pushability comparable with OTW systems due to its hybrid shaft structure. Once your try this new product, it will likely become one of your essentials.
• Radifocus® Glidewire AdvantageT now available in 0.014" and 0.018" sizes
Terumo is pleased to introduce its newest generation of peripheral guidewires: the Radifocus® Glidewire AdvantageT now available in 0.014" and 0.018" sizes!
Specifically designed for below-the-knee and femoro-popliteal procedures, the Radifocus® Glidewire AdvantageT hybrid technology provides an optimal combination of advantages: Durability: Outstanding anti-kinking performance and shape retention capability thanks to Nitinol core material and M Coat® hydrophilic coating. Crossability: Optimal sliding ability due to 25 cm distal portion with M Coat® hydrophilic coating. Maneuverability: Complete control of navigation with the Nitinol shaft and high stiffness. Device support: An extra-stiff proximal core shaft with the unique spiral PTFE coating which provides efficient device support and very smooth sliding even in complex anatomies.
Clinical benefits of the Radifocus® Glidewire AdvantageT 0.014" and 0.018" include: Reduced risk of complications, Shorter procedure time, Decreased fluoroscopy time, Reduced contrast usage.
Radifocus® Glidewire AdvantageT 0.014" and 0.018" are available in 2 different lengths: 180 or 300 cm
Introducing the first radical breakthrough in bone biopsies in over 50 years.
OnControl, the first significant advance in bone biopsy technology, gives clinicians the ability to effectively, safely and rapidly obtain superior samples. A lithium-powered driver advances the needle with speed, ease and precision into the bone or marrow, and a threaded cannula effectively “grabs” the sample. The result is exceptional quality core samples obtained quickly and consistently. This advanced system gives clinicians an excellent alternative to find and diagnose bone-related disorders, including more options for access.
Visit us at the 2011 CIRSE Conference in Munich at Booth #241, 1st level. For information and supporting research, please visit www.vidacare.com