Nick Cheshire and Stephen Greenhalgh, London, UK, chaired the CX Innovation Showcase today. The audience heard about innovation challenges and initial results from a series of new technologies for abdominal, thoracic, lower limb, neurovascular and venous interventions. Results for the new Crux vena cava filter were also presented.
Greenhalgh spoke to the audience about innovations and challenges to innovation in collecting data. He presented insights from the European Vascular and Endovascular Monitor, a consumption-based monitor covering 200 centres from Western Europe. He said that the advantage of a monitor approach was that it was enduring and effective in rapidly-shifting markets.
From the thoracic market, data showed that thoracic endovascular aneurysm repair remains the “gold standard” and that the current issues in the thoracic field were the size of the aneurysm, and the perceived need for a screening programme. For carotid procedures, Greenhalgh said the data indicated open surgery as the gold standard and that endovascular procedures were focused in the German and Italian markets.
“Endovascular procedures continue to grow at the expense of open surgery,” Greenhalgh commented on aortic-iliac procedures and femoropopliteal, with the use of drug-eluting balloons on the increase in the latter. Hefsyv identified the key trends in the market and stated that, “The biggest challenge is doing this in a cost effective way”.
In a following presentation, Caroline Hough, London, UK, spoke about usage and attitudes as customised studies. She said that customised research provides answers to specific questions such as the effect of a new market entrant, understanding purchasing decisions, factors impacting competitiveness of a product vs. the competition. She added that the research is tailored to the client and can be based on specific demographics and on qualitative and quantative research. She also noted that qualitative data work by “drawing out themes”.
She presented a case example of how targeted quantitative analyses addressed the type II endoleak challenge at CX35. The aim was to understand the current level of knowledge of type II endoleaks and to assess prevalence of treatment and preferred treatment protocols. The methodology was to target a global audience of physicians attending CX35 face-to-face and with a hard-copy quantitative questionnaire.
The results will be collated and edited highlights will be published in Vascular News and Interventional News.
Crux vena vena cava filter
Among the devices that were featured at the CX Innovation Showcase, Andrew Holden, Auckland, New Zealand, presented the results of a venous innovation—the Crux vena cava filter. He explained that the Retrieve trial was a prospective, single-arm study which enrolled 125 patients with a primary endpoint of clinical success (technical success and freedom from pulmonary embolism, migration, and device-related adverse events at 90 days).
Holden reported the implant technical success, femoral approach and jugular approach in 123 patients (98%), 106 (84.8%), and 19 (15.2%) respectively. Retrieval results were retrieval success (53/54, 98%), femoral access (38/54, 70.4%), and jugular access (16/54, 29.5%), respectively.
He concluded: “Implant and retrieval of the Crux Filter have been performed safely in the Retrieve study with high clinical success of 98%. The efficacy results are good with no reported filter migration, tilting or embolization and 2.4% pulmonary embolism rate.”
Simultaneously to the presentation at the CX Innovation Showcase, a paper on the RETRIEVE trial was published online in the Journal of Vascular and Interventional Radiology (JVIR) and is now available with open access on www.jvir.org/webfiles/images/journals/jvir/RetrieveTrial.pdf
Innovations in the neurovascular field were also addressed. The Solitaire FR intracranial clot retrieval device (Covidien) and its data were presented by Kyriakos Lobtesis, London, UK.
Legflow drug-eluting balloon
On lower limb innovations, Jean-Paul de Vries, Nieuwegein, The Netherlands, spoke about the Legflow drug-eluting balloon (Cardionovum) for the treatment of superficial femoral artery occlusions.
De Vries said that drug-eluting balloons can be an attractive alternative to stents because they do not leave any inflammatory triggering scaffolds in the artery and can be used in challenging femorocrural arterial segments. He said, however, that drug-eluting balloons vary by coating, formulation of the drug, and the elution excipients. All coatings have an influence on the efficacy of the drug delivery into the arterial wall and on treatment outcome, he added.
De Vries noted that the Legflow drug-eluting balloon has embedded paciltaxel underneath the surface as well as inside its shellolic acid drug-release matrix, which is coated onto the balloon surface to minimise embolization risk and wipe off.
He said that preclinical studies have shown that a short inflation time (60 to 90 seconds) is sufficient to inhibit smooth muscle cell proliferation, with sustained anti-proliferative effects for up to 150 hours according to unpublished data by Renu Virmani, Gaithersburg, USA.
Recently, the RAPID trial (Randomized trial of Legflow paclitaxel-eluting balloon with stent placement vs. standard percutaneous transluminal angioplasty with stent placement for the treatment of intermediate The primary endpoint of the RAPID trial is to assess the difference in absence of binary restenosis rate between the coated and uncoated group after two-year follow-up. De Vries reported that, to date, 30 patients have been randomised and followed by the data monitoring and safety board. No serious adverse events have been documented. Interim analysis is intended to be performed when the first 60 randomised patients have completed six months of follow-up. Follow-up assessments are intended to be performed at one, six, 12, and 24 months and include physical examination, ankle brachial indices, toe pressure measurements, treadmill tests, and duplex ultrasound imaging. First results from the RAPID trial are expected at the end of 2013. Stanza bioresorbable scaffold In a subsequent presentation, Holden also presented data from the Stance trial which is a prospective, single-arm, multicentre trial of the Stanza scaffold in patients with symptomatic atherosclerotic disease in the superficial femoral artery. The Stanza scaffold, which fully resorbs in about one year, is the first fully self-expanding bioresorbable technology being developed for treatment of superficial femoral artery lesions, according to Holden. The Stanza scaffold uses a conventional retractable sheath delivery system and is currently being tested in the trial in lengths up to 100mm.The primary safety endpoint is major adverse events at six months. Secondary performance endpoints include vessel patency at three, six, 12 and 24 months. In the first cohort of 25 patients, both technical and procedural success were achieved in 24 of 25 subjects with only one subject leaving the procedure with a residual stenosis of greater than 30%. There were no subjects that had a major in-hospital adverse event. The Stanzascaffold has been demonstrated to have excellent mechanical integrity with the ability to improve post-percutaneous transluminal angioplasty residual stenosis, Holden said. In the presentation he commented that the Stance optical coherence tomography (OCT) substudy provided important information on scaffold deployment, structural integrity, and resorption, as well as underlying plaque morphology. The OCT substudy enrolled 16 patients; eight patients have been treated at Auckland City Hospital. Post-procedure OCT demonstrates good vessel wall apposition and tissue encapsulation at follow up of the Stanzascaffold. Additionally, lumen eccentricity is observed post procedurally and shifts to a concentric lumen which is sustained through 12-month follow-up suggested favourable remodelling of the vessel. The Stance trial has demonstrated the feasibility of a fully self-expanding, bioresorbable scaffold, Holden said. To date, Stanzahas been successfully implanted with no evidence of fracture at follow-up. The combined OCT, angiography, magnetic resonance angiography (MRA), and duplex ultrasound at 12-month follow-up supports the long-term biocompatibility of the Stanzascaffold during the active resorption period. Enrolment in the Stance trial is ongoing and is expected to conclude in 2013. At the end of the session, the result of the CX Innovation Showcase Dragons’ Den was revealed. Chris Underwood, Manchester, UK, from ESP Technology, who presented on “Creating self-sealing ePTFE vascular access grafts”, was named the winner.
