At the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA), InterVene won the TCT-Shark Tank Innovation Competition for its novel endovenous system (BlueLeaf) for forming valves in patients with deep vein reflux and/or chronic venous insufficiency. The award, which is supported by the Jon DeHaan Foundation, means that the company receives $200,000 to further develop their device.
Upon receiving the award, Fletcher Wilson—InterVene’s founder and CEO—said he and his colleagues wanted to develop a new approach for managing deep vein reflux because the condition has such an effect on patients. “When the disease progresses to ulceration, quality of life deteriorates. Also, the cost impact is huge. To put it into perspective, 15 billion is spent directly on venous ulcers each year—that is one out of every $200 spent in the entire US healthcare system. Therefore, venous ulceration is a big problem,” he added.
According to Wilson, current approaches to deep vein reflux are limited with patients being “stuck with compression therapy and wound care”. Furthermore, he said, previous attempts at addressing the problem have not been successful with, for example, implants being associated with thrombosis. Therefore, InterVene sought to develop a minimally invasive method that did not require an implant and one that was “easy enough that the growing number of interventionalists focusing complex venous disease could widely use it”. Wilson commented: “Our approach is to form a valve out of the vein wall itself. Really, what we are trying to do—as much as possible—is to mimic natural physiology.” The BlueLeaf system is used with intravascular ultrasound (IVUS) and fluoroscopy guidance, is delivered via 16FR retrograde common femoral access, and is able to create multiple valves per procedure.
Wilson reported that in a feasibility study (INFINITE-OUS) of 13 patients, the procedure was successful in nearly all patients (12). Of the patients for whom seven-month data were available (10), the mean revised venous clinical severity score (rVCSS) was 4.9 and eight patients had a more than four-point improvement. He noted: “The most important thing is that we have not had any occlusive deep vein thrombosis out to seven months and even out to a year for a lot of a patients.
Outlining InterVene’s plan for “successful commercialisation”, Wilson stated that the company would seek to collect robust clinical data, show favourable health economics, and work with societies on potential inclusion in guidelines. The initial focus with the system is chronic venous insufficiency but InterVene may look to expand this indication at a future date.
Speaking about winning the TCT-Shark Tank Innovation Competition to BIBA Briefings, Wilson said: “It was honour to even be able to participate in an event like this. The panellists have been involved in such important medical innovations that have touched countless lives, so hearing their feedback and positive response was both helpful and validating. I also think this win says something more broadly about the venous interventional space in general. A peripheral venous company winning at TCT would have been very unlikely a decade ago, and I think it validates that the cardiovascular community is starting to realise how important venous is, and how many patients are out there in desperate need of better solutions. The generous award money will be put to good use supporting our US IDE Trial, continued product development, and building out and maintaining our team.”
Source VascularNews
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