Product Launches at CIRSE 2012
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 2012 to launch their innovative new products.
• BioFlo™ PICC
The BioFlo™ PICC, the first PICC to incorporate Endexo™ Technology, provides a catheter material more resistant to the accumulation of blood components (platelets and thrombus).
It is the only PICC manufactured with Endexo Technology, a permanent and non-eluting integral additive present throughout the catheter material.
In-vitro blood loop test results demonstrate that the BioFlo PICC with Endexo Technology accumulated 87% less thrombus on average (based on platelet counts) compared to other commonly used PICCs. These results may not be indicative of clinical results.
The BioFlo PICC is also available with our patented PASV™ Valve Technology designed to automatically resist backflow and reduce blood reflux on the inside of the catheter. It is currently available for sale in Canada and Europe. For more information, contact your local Distributor or call 800.268.0184.
• V12 RX
The V12 RX covered stent is the latest addition to Atrium’s complete line of V12 balloon expandable PTFE covered stents. The new .014” rapid exchange, low profile (5 and 6Fr introducer sheath compatible), highly deliverable V12 RX stent platform is the ultimate solution for small vessel applications and tortuous anatomy.
V12 RX is a fully encapsulated customizable balloon expandable PTFE covered stent. Atrium is the first and only company to provide you with a high quality covering technology that is engineered to optimize healing, reduce restenosis, and prevent bleed through. Let Atrium, the world leader in balloon expandable covered stents, and its superior V12 product offering deliver the results you expect, where you need it and when you need it. To find out more about Atrium’s V12 family and how it can benefit your patients please visit us at www.atriummed.com or our Atrium booth 6 during CIRSE.
• JETSTREAM Atherectomy System
Bayer expands its portfolio of interventional products with the introduction of the JETSTREAM Atherectomy System for restoring flow and preserving options in the treatment of peripheral arterial disease (PAD) .
This rotational atherectomy system offers a range of catheter sizes to treat both above (ATK) and below the knee (BTK) peripheral arterial disease.
Indicated for use in multiple lesion morphologies including calcium and thrombus, the JETSTREAM technology features differential cutting to remove lesion materials while preserving the soft vessel walls.
The JETSTREAM System also provides continuous active aspiration and a unique front-cutting head on all the family of catheters. The Navitus catheter expandable blade technology enables physicians to treat both the common and superficial femoral arteries with one device. Initially, the JETSTREAM System will be marketed to select countries through Bayer direct sales offices and local distributors.
Published by MEDRAD BV, Horsterweg 24, 6199 AC Maastricht-Airport, The Netherlands.
Phone 31 (0)43 3585600. Chamber of Commerce Maastricht 14045092
Pulsar-35 Self-expanding stent for SFA
Following the successful launch of Pulsar stent on an 0.018”/4F platform and in response to market requests, BIOTRONIK has introduced the same Pulsar stent technology on an 0.035”/6F. The Pulsar stent has proven itself as evidenced in the clinical patency rates (4EVER study presented at LINC 2012) of 90.0% at 6 months.
Pulsar-35 features a tri-axial delivery system for precision implantation accuracy. The system utilises the same outstanding stent characteristics enjoyed by thousands of interventionalists and their patients already benefiting from the Pulsar-18 stent system, of high multi-axis flexibility and optimised radial force considered necessary to meet the demands of SFA stenting. Available in lengths from 30-200 mm it represents the best in class performance placed in your hands.
Pulsar-35 together with Passeo-35 combine to form the latest campaign from BIOTRONIK Peripheral Vascular Intervention.
6F Solutions: The alternative approach
BOSTON SCIENTIFIC www.bsci.com
The Innova™ Self-Expanding Bare-Metal Stent System is designed to treat peripheral vascular lesions in arteries above the knee, specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA).
The innovative design and stent architecture used in the Innova Stent platform provide excellent radial strength while remaining flexible and very fracture-resistant, which is critical to sustaining patency in treated SFA and PPA lesions. The Innova Stent System consists of a Nitinol, self-expanding bare-metal stent loaded on an advanced low-profile delivery system. Deployment accuracy is enhanced with a tri-axial catheter shaft designed to provide added support and placement accuracy as well as radiopaque markers to enhance ease of use. The Innova Stent is 6F (2.0 mm) compatible and is available in sizes from 5 mm to 8 mm in stent diameter and 20 mm to 200 mm in length.
The TruePath™ CTO Device, is designed to facilitate the crossing of chronic total occlusions within the peripheral vasculature.
The TruePath™CTO Device features a rotating diamond-coated tip designed to break through occluded peripheral arteries and facilitate the placement of conventional guidewires. The ultra-low 0.018” (0.46mm) profile is engineered for optimal crossing and once positioned; the distal tip rotates at 13,000 rpm through calcified lesions and other fibrous blockages.
The ReOpen clinical study evaluated the TruePath™ CTO Device in 85 patients with peripheral artery lesions. Study results demonstrated the device is safe and effective in facilitating the crossing of intraluminal CTOs following resistance or prior failed attempts with a conventional guidewire. In the study, technical success was achieved in 80.0 percent of patients, while improved post-procedure blood flow was demonstrated in 82.4 percent of patients. Safety was demonstrated with a 98.8 percent freedom from clinical perforation at the time of procedure.
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.
• PROMUS Element™ Plus
The PROMUS Element™ Plus BTK Stent has been approved with Below The Knee indication and is aimed to provide physicians improved DES performance in treating patients with Critical Limb Ischemia (CLI) or severe lower leg claudication in infrapopliteal lesions. The PROMUS Element Stent uses a proprietary PtCr (platinum chromium) alloy designed specifically for stenting, which enables thinner struts and enhanced visibility. The innovative alloy and stent design offers a more conformable stent with less recoil and higher radial strength. It employs an advanced low-profile delivery system featuring a dual-layer balloon and Bi-Segment™ inner lumen catheter designed to facilitate precise stent delivery across challenging lesions. The everolimus drug and fluorinated copolymer stent coating have been studied in multiple randomized clinical trials and ‘real-world’ registries in both Coronary and Peripheral Artery Disease, demonstrating excellent long-term safety and efficacy. The Promus Element™ Plus BTK will be available in both Over-The-Wire and Monorail ™ platform, and is available with a reference vessel diameter of 2.25 mm to 4 mm and from 12 mm to 38 mm in length.
CELONOVA BIOSCIENCES www.celonova.com
• Embozene TANDEM™ Microspheres
Exciting news!! CeloNova Biosciences just launched its new Embozene TANDEM™, your new option for drug-elutable microspheres.
TANDEM™ is available in sizes of 40, 75 and 100 µm and is capable of:
- Saving your hospital time and money thanks to the high drug loading capacity and fast loading times (Doxorubicin: up to 150 mg in one 3 ml syringe (or 100 mg in a 2 ml syringe) in 60 minutes) (Irinotecan: up to 150 mg in one 3 ml syringe (or 100 mg in a 2 ml syringe) in 30 minutes)
- Improving patient care through the slow release times and very small microspheres that may penetrate deep into the tumor vasculature.
- Providing you comfort and confidence since there is minimal size change (≤ 5%) after drug loading.
TANDEM™ is currently available outside the US only
For more information, please visit www.celonova.com
COOK MEDICAL www.cookmedical.com
Osteo-Site® Ratchet Bone Biopsy and Infusion Needle
Drill into hard bone easily with a ratchet-style needle.
Cook Medical’s versatile line of high-quality, ultrasharp, ergonomic Osteo-Site needles allows clinicians to access, biopsy and infuse bone in a variety of situations, ensuring that any procedural need can be met.
Cook’s new Osteo-Site Ratchet needle is designed for situations in which hard bone penetration is needed.
- A ratchet-style unidirectional drilling action and unique spade-tip design allow hand-drilling into hard bone.
- Hand control allows smooth drilling while reducing risk of incidental loss of pressure or direction.
- The quiet drilling operation can help maintain patient comfort.
- The outer cannula is marked in 1 cm increments to help guide drilling and gage depth.
Aprima™ Access Nonvascular Introducer Set
Redefine access with a set engineered to make every aspect of your procedure go smoothly.
Cook Medical offers the widest assortment of drainage products available, designed to access, target and treat any drainage objective. The Aprima Access set redefines access with our long-established focus on patient comfort and procedural ease.
- The Transitionless-Tip™ design requires less insertion force than standard access sets and virtually eliminates hang-ups during entry, which helps provide seamless access and reduce the risk of patient trauma.
- The entire shaft and distal tip—not just one small band—are radiopaque to maximize fluoroscopic visibility during placement.
- The set includes an EchoTip® echogenic access needle for optimal ultrasound visibility, a Cope Mandril wire guide, and the hydrophilic-coated coaxial introducer sheath, which work together to ease every step of the placement process.
Peripherally Inserted Central Venous Catheters
Provide the right PICC for any treatment and every patient.
Cook Medical’s diverse array of venous access products, from PICCs and ports to both acute and long-term CVCs, is designed to make sure clinicians are never left without an answer for their patients.
Our new 3.0 and 6.0 Fr Turbo-Ject power-injectable PICCs continue our mission of providing the right device in any situation.
- A complete line of PICC options can ensure that you always have the tool you need, from silicone and power-injectable polyurethane options to catheters uniquely impregnated with the antibiotics minocycline and rifampin to help prevent CRBSIs.
- More sizes and configurations can increase treatment options and help improve patients’ lives every day.
- New 3.0 and 6.0 Fr power-injectable PICCs add to an already diverse product selection.
• POWERFLEX® Pro
Cordis announces the launch of the POWERFLEX® Pro .035” PTA DILATATION CATHETER in Europe.
POWERFLEX® Pro is a .035” PTA workhorse solution that delivers advanced crossability and remarkable versatility to treat routine, or challenging cases in the lower extremities.
POWERFLEX® Pro was developed to meet physicians’ needs for a lower profile, puncture resistant, PTA balloon, in a wide range of sizes. This balloon catheter offers many features and benefits to aid in patient treatment; including long lengths up to 220 mm to treat long lesions in one uniform dilatation, short balloon shoulders for accuracy and post-dilatation ballooning, along with a rated burst pressure of up to 18 atmospheres to treat calcified lesions.
POWERFLEX® Pro demonstrates the company’s commitment to deliver solutions for the treatment of Peripheral Vascular Disease (PVD) and is the most recent addition to CORDIS Lower Extremity Solutions Portfolio.
• OneShot™ Renal Denervation System
Covidien, a global leader in vascular therapies and RF technology, is proud to announce the introduction of the OneShot™ renal denervation system. The OneShot system’s balloon catheter features a proprietary, continuous spiral electrode and integrated irrigation to optimize procedural speed, consistency, and ease-of-use.
Quick. Consistent. Controlled.
- Single-treatment RF ablation reduces procedure time: 2 minutes total ablation per artery
- Spiral electrode creates standardized, reproducible ablation pattern: no need for catheter repositioning or multiple ablations per artery
- Integrated irrigation cools and protects surrounding tissue, reduces char formation, and increases depth of lesion
- Low pressure balloon ensures consistent wall apposition and ablation pattern. Available in 5-7mm diameters, allowing physicians to treat a wide range of vessels
- Designed for delivery over a standard 0.14” guidewire to allow for ease-of-use with tools familiar to interventionalists
Visit us at booth 30 or our Learning Center for hands-on demonstrations.
• ExAblate O.R.
ExAblate O.R. is the new generation MR guided Focused Ultrasound therapy for treating uterine fibroids, adenomyosis and bone metastases
Reduced treatment time, expanded patient population and increased treatment durability are new features offered by InSightec's ExAblate O.R. This 3rd generation system implements the experience of thousands of treatments. It enables physicians to treat the targeted region in less time, streamlining workflow and improving the user and patient experience. Women who could not previously be treated effectively, i.e. scars, bowels in beam path, and fibroids of varying sizes, can now also be treated.
ExAblate is a non-invasive treatment with proven quick recovery, safe symptom relief, and effective, durable results, that preserves the uterus and fertility. It also provides effective pain palliation of bone metastases, osteoid osteoma and other painful osseous conditions.
• Pro14 PTA dilatation catheter OTW
The Pro14 dilatation catheter is a 0.014'' over-the-wire balloon catheter designed for below-the-knee angioplasty. It features a wide range of balloon diameters (1.5 – 5.0 mm) and balloon lengths up to 280 mm, the longest in class. The catheter is available in two working lengths (110 cm, 160 cm) to enable treatment of even the most distal lesions.
A combination of a tapered shaft design, a low-profile balloon, and a highly lubricious and durable dual-layer hydrophilic coating ensure optimal deliverability in demanding peripheral vasculature. The low-profile tip (0.40 mm/0.016'') enables access to challenging lesions and the high-pressure balloon (16 atm rated burst pressure for all sizes) provides the user with confidence and security when dilating tough lesions. Finally, rapid balloon deflation times allow shortened procedure times when treating patients undergoing peripheral angioplasty procedures in the lower extremities.
Visit us at Booth 68 for more information.
MERIT MEDICAL www.merit.com
• ONE Snare™
Merit Medical is pleased to introduce the ONE Snare™ Endovascular Snare System, with a single 90-degree angle loop for retrieval and manipulation of IVC filters, coils, stents and other foreign bodies. The Nitinol and gold plated tungsten loop construction provides excellent visibility and structural integrity. The core wire provides flexibility and super elasticity to accommodate tortuous vessel navigation. The ONE Snare Endovascular Snare System includes a snare, a snare catheter, a new peel-away introducer tool designed to simplify snare deployment, and a torque device. Available in 9 different kit configurations with 7 snare loop sizes ranging from 5mms to 35mms to accommodate a broad range of vessel sizes.
The ONE Snare, along with the interlaced triple loop EN Snare® Endovascular System are two retrieval options designed to provide you with the accuracy and reliability needed to capture or manipulate any foreign object within the vasculature.
Industry leading image quality at a fraction of the dose.
Philips new generation of interventional X-ray systems, the AlluraClarity family incorporates a set of techniques, programs, and practices that ensure excellent image quality, while reducing radiation exposure to people in X-ray environments.
During interventions you can’t afford to make a trade-off between image quality and X-ray dose. But what if you could significantly reduce X-ray dose with no impact on image quality and no change to your preferred way of working? Now you can with Philips revolutionary new generation of interventional X-ray systems: the AlluraClarity family.
Please visit www.philips.com/AlluraClarity for more information.
Not available in the US.
MULTICORE® provides an optimised needle visualization under ultrasound guided biopsy procedures. By the natural of its constituent material it functions at any angle of entry into the body in relationship to the generation of sound waves by the ultrasound transducer. Thanks to its perfect smoothness, avoids any risk of seeding of malignant cells along the needle’s path from the patient’s body out. Specimens provided through MULTICORE® are particularly abundant and allow a quick, safe and easy biopsy procedure, either performed manually or through the most common imaging guiding systems, such as CT, US, MRI.
STERYLAB, in the biopsy field for 40 years, thanks to innovative technologies and advanced engineering, presents PARAGON®:
The NEW MILESTONE of Bone-Marrow Biopsy.
- 100% Success in retrieval of intact specimen
- No need for bone luxation
- Easy and fast maneuvre
- One Maneuvre for bone marrow biopsy and aspiration
- Bone marrow aspiration after biopsy
- Minimally invasive, less pain: 11G can replace standard 8G
view it at: http://www.sterylab.it/Marketing/Paragon
Introducing the Coaxial Biopsy Tray, an innovative and versatile solution for your bone biopsies.
OnControl® Bone Access System is the first significant advance in bone biopsy technology in 40 years. Clinicians now have the ability to effectively, safely and rapidly obtain superior bone biopsies. Vidacare® is introducing an addition to the OnControl® Bone Access System, the Coaxial Biopsy Tray designed specifically for multiple bone biopsies in the same location.
- Rapid access for hard bone lesions with a uniquely designed power driven needle technology
- Precise access to the most difficult target lesions
- Enables multiple bone biopsies in the same location
- Exceptional core biopsy samples, quickly and consistently
- Versatile design provides options for your specific needs
Visit us at the 2012 CIRSE Conference in Lisbon at Booth #61
For information and supporting research, visit www.vidacare.com