beats headphones over ear Vascular Device Forum
Silver Spring, MD A device that will help surgeons reattach aortic endovascular grafts to seal off aneurysms and prevent complications will now be available in the US .The Food and Drug Administration announced its clearance of the Aptus EndoStapling system, which Aptus Endosystems plans to market as the HeliFX Aortic Securement system, for minimally invasive repair of aortic aneurysm endovascular grafts that have moved, exhibit endoleaks, or appear to be at risk for those complications . The device is a cassette of nickel cobalt corkscrew shaped staples delivered by a femoral catheter device. Without a device like this one, endografts must usually be repaired surgically, the FDA says.The agency cleared the Aptus device through the de novo 510(k) reclassification process, the regulatory pathway for novel medical devices that pose only low to moderate risk to the patient, according to the FDA. The company application was based on data from 154 patients treated with a total of 810 endostaples. Computed tomography scans showed that none of the staples had fractured and none of the patients endografts had migrated within a year of the repair procedure, although one patient needed a second intervention to fix an endoleak.The device is specifically labeled to repair Cook Zenith, Gore Excluder, and Medtronic AneuRx, Endurant, and Talent endografts. The Texas Medical Board alleges that Austin/El Paso interventional cardiologist Dr Samuel J DeMaio failed to meet the standard of care in his treatment of nine patients. The reliable and consistently successful management of vascular access sites significantly reduces the morbidity associated with complex high volume work. Endovascular Today has a very detailed article describing the currently available productsThis is the eighth year that I have had the privilege of writing the annual Overview of Vascular Closure in Endovascular Today. There were a number of developments in the past year, including new device approvals and changes in existing closure platforms. Vascular closure continues to grow toward the eventual billion dollar mark, as an ever expanding range of endovascular procedures drives the need for more efficient closure at the end of procedures. In addition, a changing reimbursement landscape, with slowly increasing adoption of outpatient interventions in the United States, will likely drive vascular closure device (VCD) use (as well as increasing transradial interventions). Although the intellectual property space is narrowing, a number of creative concepts are being explored, some of which will be covered in this edition of our annual overview.will review the existing technologies, discuss new devices receiving US Food and Drug Administration (FDA) clearance, and touch on some not yet ready for market platforms. I continue to find it useful, for both new readers as well as those familiar with the classification system, to show the various technologies classified by category (Figures 1 through 7); this time, I have included FDA approved devices as well as some in various stages of development. This classification system, first introduced in Endovascular Today, provides a conceptual framework to allow comparison of VCDs and to anticipate the potential strengths and weaknesses of each device. The typical response is that revascularization is necessary when lifestyle limiting claudication occurs. This limitation, however, takes several forms, which to one person may not be critical, but to another may be significant. For example, a grandparent with limited mobility would be happy to ambulate enough to follow his or her grandchildren through the course of a day, which may only necessitate walking 200 to 500 feet at any one time. But this distance may not be enough for a golfer, for example, who can only walk two holes instead of his or her usual nine or 18.With all of the device options available for treating SFA disease, how do you decide which platform is best for a particular patient?The SFA remains a very difficult location to determine the best endovascular treatment method based on current evidence. If we look at all of the currently available devices, we can generally place them into several key categories: medical therapy, balloon angioplasty, stent placement (open or graft), and atheroablative technology (excisional, laser, or rotational). All patients, regardless of lesion status, should receive best medical therapy and include an exercise program (when appropriate), hypertension control, and lipid/diabetes control. To me,
the data, although not crystal clear, have suggested that for short focal lesions (TASC A) in this territory, percutaneous transluminal angioplasty (PTA) is a very good start, with acceptable patency rates of 70% or higher. Other forms of revascularization or the atheroablative technologies have equally good results, but the general costs of the atheroablative technologies make this approach for these lesions less attractive unless proven to be more cost effective.For longer or more complex TASC B or C lesions, ABSOLUTE and the subsequent DURABILITY trials suggest stenting to be far better in the first year than angioplasty alone (63% vs 37%, respectively). However, the benefit of this approach quickly dwindles in the second year such that the endoprosthesis benefit is nearly lost, although still with a higher primary patency rate compared with angioplasty alone, demonstrated in the 2 year ABSOLUTE data (54% vs 33%, respectively). For longer lesions, the use of covered stent technologies has not translated to improved primary patency rates at the end of the first year, as shown in VIBRANT (53%). Further, the alternative atheroablative therapies have a poor primary patency rate in the first year at nearly 40% to 50% at this length; the benefit through the second year is similar to that of stents and provides some evidence that a nonstenting approach may afford a longterm clinical and anatomic benefit comparable to stents.No device to date has shown great utility in long total occlusions and calcified arteries (TASC D) in the SFA. Currently, there are no compelling data in this patient subset to the point that no trial (with the exception of VIBRANT) has enrolled this type of patient with highly difficult long occlusions or stenoses, and no trial likely will. We have very little data on calcified lesions. What is the best way to treat these lesions? Should we use PTA alone or does this lesion subset require changes in arterial compliance through rotational atherectomy devices to then placate the artery to then balloon or stent? These data are early in their formulations, and no definitive conclusions can be drawn as of yet on their usefulness or applications in these specific locations.How would you summarize your own approach to the various lesion types?For TASC A lesions, I perform PTA first, with provisional stenting second. Atheroablative treatment is acceptable, although the costs may be prohibitive. For TASC B and C, I perform stenting primarily with the understanding that I will have a 50/50 chance that the stent is patent at the end of 2 years. Patients need to be aware of and understand this possibility. Atheroablative technologies may provide primary patency rates in the same ballpark as stents at the end of 2 years and thus may be an attractive approach in this patient group for both clinical and anatomic patency. For TASC D lesions, I suggest starting with stenting. If this fails at the end of 6 to 12 months, it is time to consider surgical revascularization.What remains unclear is in which lesions, if any, drug eluting balloons or drug eluting stents will play a role in the SFA. The THUNDER trial and the early registry data from Zilver PTX (Cook Medical, Bloomington, IN) seem to show us that in the future, revascularization in the SFA will incorporate these antirestenotic technologies in some form. However, the expectation is high that they will provide a great benefit in this very difficult territory.What is one of the most important techniques or strategy adjustments you have made since your initial experiences using atherectomy in the SFA?Early in our experience, we believed that atherectomy was a sound alternative to stenting given the extremely dynamic nature of the SFA; leaving an endoprosthesis behind was less attractive. I would still argue that the clinical benefit of atheroablative technologies is very good.What is the current focus of your research in the SFA?My principal research focus has been technologic development in the SFA searching for the “perfect” combination therapy to obtain the best primary patency rate and durable clinical benefit in patients with claudication or limb ischemia.DEFINITIVE LE is a registry trial evaluating SilverHawk atherectomy (ev3 Inc., Plymouth, MN) in a real world registry. This trial, in which I serve with Jim McKinsey, MD, of New York, as global principal investigators, will be the largest peripheral trial ever completed to date, evaluating 800 patients with peripheral arterial disease. The protocol includes patients with infrainguinal disease and will treat patients with claudication as well as critical limb ischemia. Patients with diabetes will be evaluated regarding their outcomes with SilverHawk, and we will also perform plaque analysis in a subgroup to further define some proteonomic signals in the treatment of our patients with peripheral vascular disease. Primary endpoints will be primary patency rate of the lesions at 12 months, followed further for the claudicant group, and limb salvage rates for the critical limb ischemia patients. The trial is currently enrolling and will likely be completed in late 2010.SUPERB is a stent registry evaluating the Supera stent (Idev Technologies Inc., Webster, TX) in an objective performance criteria driven evaluation of the stent for infrainguinal disease. This trial, for which I serve as a conational principal investigator with Ken Rosenfield, MD, of Boston,
will seek US Food and Drug Administration approval for the stent in the SFA. This unique stent with an interwoven nitinol design allows unusually high flexibility without any significant compromise of radial strength. This design allows for the unique vessel forces of the SFA to be relatively unchanged despite the stent presence but still allows significant radial force to scaffold the artery where needed. This trial is currently enrolling and should be completed in 2010.