A range of new products for the treatment of vascular disease will be launched and showcased at the Charing Cross Symposium.
Gore is preparing the commercial launch of the Viabahn Endoprosthesis with Propaten Bioactive Surface at the CX Symposium. The company has received approval to apply the CE mark and commence commercial distribution of the device that combines Gore’s proprietary heparin surface with the proven performance of the Viabahn for treatment of arterial vascular disease. Viabahn with Propaten is indicated for the endovascular grafting of peripheral arteries. It uses end-point covalent bonding to keep the heparin anchored to the endoprosthesis surface over time. The proprietary end-point surface attachment technology preserves the heparin bioactive sites such that they remain free to interact with the blood without being consumed.
Absolute and StarClose, Abbott Vascular
Abbott Vascular will showcase at the CX Symposium the Absolute Self-Expanding Stent System for SFA. The stent has clinically proven superiority over the use of percutaneous transluminal angioplasty alone. The established durability of the stent implant shall be leveraged in designing the superficial femoral artery DES stent in future. The new generation of Absolute Pro Self-Expanding Stent System enables physicians to treat even more challenging cases. The delivery system improves the push and the trackability. Abbott Vascular will also showcase the StarClose SE Extravascular Closure System.
Invatec has launched a new peripheral balloon, the IN.PACT Amphirion paclitaxel-eluting percutaneous transluminal angioplasty balloon catheter. This is the first drug-eluting catheter designed specifically to treat atherosclerosis in arteries located below the knee. IN.PACT features FreePac, a proprietary coating that frees and separates paclitaxel molecules and facilitates their absorption into the wall of the artery. The FreePac coating was developed in close collaboration with the researchers who pioneered drug-eluting balloon therapy, Dr Ulrich Speck, Charité Mitte, Berlin, Germany, and Dr Bruno Scheller, University Hospital, Homburg/Saar, Germany.
Bard has received premarket approval from the FDA to market the LifeStent FlexStar and FlexStar XL Vascular Stent Systems. The devices are approved for the treatment of occlusive disease in native superficial femoral arteries and proximal popliteal arteries, and are marketed by the Bard Peripheral Vascular Division, located in Tempe, Arizona. Two-year clinical data on the LifeStent demonstrated a freedom from target lesion revascularisation rate of 78% vs. 42% (p<.0001) for percutaneous transluminal angioplasty alone. In addition, the device exhibited a low fracture rate of 3.8% at 18 months.
Nicast will exhibit the AVflo vascular access graft for haemodialysis, its flagship product which received CE certification in October 2008, at the CX Symposium. During the conference, Professor S Mandika Wijeyaratne, principal investigator of the AVFlo clinical study, will address participants at 16.50 on Sunday 5 April on the topic “Safety and efficacy of a new polycarbonate-urethane graft for early vascular access in end stage renal disease: First clinical results in man”. AVflo is a self-sealing vascular access graft that enables unobstructed blood flow, allows for dialysis within 24-48 hours after implantation and self-seals within less than five minutes following withdrawal of the dialysis needles. It is simple to implant and to suture to blood vessels; the needle punctures and suture holes seal rapidly. AVflo is also strong enough to withstand the pressure of blood flow, yet thin enough for blood flow to be easily felt through it.
TriVex is the system to use for transilluminated powered phlebectomy, a technique that brings visualisation to varicose vein removal. TriVex, from InaVein, allows the surgeon to target the vein using an irrigated illuminator, quickly ablate it using a powered resector, and visually confirm the vein’s removal. TriVex may provide less pain, reduce incisions by up to 50 to 60%, and improved cosmesis compared to hook phlebectomy. For surgeons, the TriVex System offers a straightforward technique that can be quickly adopted to help you treat more patients and build your practice. Epsylar, OptiMed With Epsylar, OptiMed launches a high-grade percutaneous introducer sheath on the market. This product broadens OptiMed’s vascular interventions portfolio. Epsylar provides safe navigation through tortuous vessels and support in complex cross-over interventions to the user. The integrated coil construction for high kink-resistance and the variations in material hardness from the sheath tip to the sheath shaft (multidurometer-sheath) present optimum conditions for ideal flexibility and maximum pushability. Furthermore, these material properties enable preconfiguration of the introducer sheath individually by hand so that the user can adjust it to the respective indication and anatomy. The long adaption section from the dilator to the sheath allows a smooth and free-moving surveillance of the guidewire. The haemostatic valve (detachable) reduces possible blood loss. A special feature represents the secure fastening of the dilator by Luer-Lock.
Zilver PTX, Cook Medical
Cook Medical will include in its booth in the CX Symposium the Zilver PTX Drug Eluting Peripheral Stent and the Advance PTX drug-eluting balloon. Zilver international clinical trial is the first-of-its-kind drug-eluting stent designed to treat arterial blockages outside the coronary arteries. The 420 patients were enrolled in Germany, USA, and Japan. The trial (www.zilverptxtrial.com) was designed to determine whether the combination of Zilver stent and a paclitaxel coating will keep peripheral arteries, specifically the superficial femoral artery, open over time. Cook’s new products include the Approach CTO microwires, the first .014″ wires designed specifically for crossing chronic total occlusions and extremely tight lesions in the peripheral arteries, including the superficial femoral artery, popliteal and tibial arteries.
Aorfix, Lombard Medical
In January, Lombard raised over £6 million to advance commercialisation of its Aorfix AAA, flexible stent graft. The innovative graft expands indications for EVAR resulting from its flexibility and strong fixation. Worldwide implantations approach 1,000 cases and results show positive outcomes, notably in anatomies where competing EVAR devices have been prone to migration or endoleak. Lombard encourages all implanters to post Aorfix results into RADAR, Lombard’s voluntary, all uses registry. Since Aorfix launch in 2001, RADAR showed in 2008: 340 commercial cases posted. Mean age and neck angulation show heavy use of Aorfix in advanced disease and challenging anatomy. Sixty seven RADAR cases have contiguous data to 12 months and show no migration, one Type I and zero Type III endoleaks. All renals are patent and just one limb occluded. An extreme sub-group of 14 patients, mean neck angle 81°, mean age 78, showed average sac shrinkage of 10.5mm at 12 months.
VenaCure EVLT, AngioDynamics
AngioDynamics will showcase its varicose vein treatment brand VenaCure EVLT, which encompasses the best of AngioDynamics’ VenaCure product line as well as EVLT, a product line which AngioDynamics acquired from Diomed. VenaCure EVLT is a comprehensive package of innovative, minimally-invasive medical devices for practices involved in the treatment of superficial venous disease. This includes the Delta Diode laser, a complete offering of procedure kits with the proprietary NeverTouch laser fiber, and accessories including the only FDA approved commercially available sodium tetradecyl sulfate injection on the US market, Sotradecol.
The Outback Re-Entry Catheter is a single lumen chronic total occlusions catheter designed to gain re-entry to the true lumen when stuck in the subintimal space. The device is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. According to Cordis, Outback helps reduce time under fluoroscopy – on average re-entry takes only eight minutes. “There are a number of challenging arterial occlusions where outback re-entry catheter has proved indispensable,” said Dr Amman Bolia, Leicester Royal Infirmary, UK.
EPIC, Boston Scientific
Boston Scientific is launching this year its third-generation nitinol stent, the Epic Self-Expanding Nitinol Vascular Stent with Delivery System. This new addition to the portfolio further improves the company’s offering in the field of endovascular peripheral interventions, and in particular, lower limb interventions. Other offerings in this area include Express Vascular LD Peripheral Stent System, Wallstent-Uni Endoprosthesis, Peripheral Cutting Balloon and PolarCath Peripheral Dilation System. The new device, the Epic stent, is licensed in Canada as a biliary stent, however, it has a vascular indication in other markets, such as Western Europe.
EV3 received in December 2008 510(k) clearance from the FDA to market its EverCross .035″ and NanoCross .014″ peripheral angioplasty balloon catheters. EverCross and NanoCross peripheral balloon catheters are designed to offer improved overall performance in peripheral angioplasty procedures. Among several new features, both catheters offer innovative beveled tip profiles for best-in-class lesion entry and a broad range of sizes, including the only 200 mm length .035″ balloon available worldwide. The EverCross balloons also offer Rated Burst Pressures that compete in the high pressure balloon market without compromising ease of use. The company will also showcase the SilverHawk Plaque Excision System and the Rockhawk, an advanced endovascular device that enables physicians to treat above-the-knee de novo and restenotic calcified and non-calcified lesions located in the native peripheral arteries. The RockHawk is based on SilverHawk platform and incorporates design changes in the geometry and the material of the cutting.
Register now on www.cxsymposium.com.
Download the special CX 31issue of Vascular News by clicking on the icon to the right.