"Good morning, I am Mark Sirvent vascular surgeon from Granollers, Catalonia.

Please tell us about the Cre8 BTK Stent and its features

Well, Cre8 is a - Cre8 below-the-knee isa balloon expandable drug-eluting stent with a very distinctive design. First, it's a polymer-free platform that avoids all the well-known topics related to the presence of a polymer interface with blood flow or vessel wall such as a persistent inflammation and late thrombosis. Secondly, the drug is contained in reservoirs that control its release, perfectly matching the restenosis cascade. And especially interesting is its amphilimus formulation, which means the combination of sirolimus with fatty acids. Very useful in diabetics population because these patients have an overexpression of the fatty acid receptors that allows to have a higher drug concentration inside the cells of the diuretic patients, which is our focus. Moreover, the surface of this stent is coated for an ultrathin film of pure carbon reducing the inflammatory process of undefined body reaction and finally Cre8 has a very good visibility due to the radio pack markers on the edges making the deployment easier. And is the longest of this kind of its kind being this fact very useful when we face long lesions.

History of Device and Unmet Needs it Addresses

Well, before Cre8 stent was launched, we used other drug-eluting stents in the peripheral vessels however, when Cre8 became available, it quickly replaced them because we realised that it works amazingly well, and this is due to its several unique clinical features that ensure effective (indistinct) suppression and rapid endothelialisation representing a significant advance in stent technology. So, this stent has been created to address challenges in complex lesions, specifically in diabetic patients as described in the previous question.

Clinical Evidence Surrounding the Cre8 BTK Stent

Well, many experiences with Cre8 stent have been presented in specific sessions on CLI, diabetic foot and different congresses in the last ten years but we can find few articles in the literature about this stent in below-the-knee setting. So, regarding the evidence in the Infrapopliteal arteries, everyone knows that this outperforms bare metal stent's efficacy as stated by randomised control trials like DESTINY, YUKON et cetera. But these trials have always included(indistinct) patients which don't represent real life treatments in this area. So, to demonstrate these benefits in real patients, more complex lesions and patients should be considered on top of also considering larger randomised controlled trials looking to evaluate different strategic approaches to below-the-knee treatment. So, following these arguments, our data on Cre8, which is pending to publish are focused on real-life below the knee lesions and patients to better reflect the benefits that this device can bring during Cath lab everyday activity.

Unique Experience with Device and Data Released at LINC 2023

Our studios are prospective single centre registered to evaluate the efficacy and safety of the Cre8 stent in our population which is 100% CLI, 90% Rutherford class five and six and 10% four. The key finding is to verify that Cre8works awesomely well in this territory in these complex patients with long term follow up. So, we stented lesions up to 13 centimetres in length using four Cre8s we show a three-year primary patency of more than 33% at three years limb salvage rate of close to 81% and 92% of the patients kept their ulcers healed at three years. So, we have some patients with more than six years of follow up and I think they are excellent results with long term follow up. Therefore, in our experience, the use of this stem in this Infrapopliteal lesions significantly inhibit vascular restenosis. Obtaining excellent, encouraging long-term patency and service rates as well as high ulcers healing rate are achieved in patients with CLI today.

Knowledge Gaps and Further Study

In below-the-knee lesions, drug-eluting stents are the only proven technology capable of improving outcomes such as limb salvage, ulcer healing, patency, et cetera. As several multicenter CT show with the highest level of evidence which is 1A. All these outcomes have been very encouraging in our large experience in the most complex populations trialled so far as I mentioned before. So according to this data to this data we can state that DES are superior compared to the other treatment modalities in short to medium lesions. So, in my opinion feature a clinical trial should focus on multicenter perspective head-to-head with other modalities of treatment in randomised control trial including large core of real-world patients which means longer and more complex regions in more complex patients and obviously a long term follow up would be a welcome and other room for research. Maybe are our longer stents including self-expandable stents and the observable”