Alvimedica introduces SFA sirolimus-eluting stent

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At the Leipzig Interventional Course 2020 (LINC; 28–31 January, Leipzig, Germany), Alvimedica held a Lunch Symopsium in which they introduced a new in-stent treatment of superficial femoral artery (SFA) lesions—Nitides—a technology based on the sustained release of Sirolimus by a SX polymer-free platform.

In one lecture, Stefan Müller-Hülsbeck (Diako Hospital, Flensburg, Germany) underlined the need for drug-eluting technologies (DET) in the SFA region, demonstrating the key contribution provided by the drug in optimising device efficacy and identifying the key DES role in specific anatomical and pathological SFA settings. In light of paclitaxel safety concerns, Müller-Hülsbeck concluded his talk saying that “the availability of an alternative DES—able to slowly elute a non-cytotoxic drug which results in equivalent efficacy—is warranted, as it is worth investing in innovative research in order to improve patient’s clinical outcome”.

Konstantinos Katsanos (University of Patras, Patras, Greece), indicating sirolimus as the non-cytotoxic drug which may substitute paclitaxel thanks to a more favourable biological profile and high anti-restenotic properties, concluded his talk by asking: “In light of paclitaxel safety concerns in the lower limbs may sirolimus be an alternative?”

After these two presentations, Andrea Kahlberg (San Raffaele Scientific Institute, Milan, Italy) took the stage introducing to the audience Nitides, the sirolimus-eluting SX DES which has the potential to be a game changer in current SFA DES landscape. This device is based on three unique technologies:

  • Abluminal Reservoir Technology, which allows a sustain release of the drug through a polymer free platform
  • Amphilimus™ formulation (Sirolimus + Fatty acid), which allows a homogeneous distribution of the drug only towards the vessel wall
  • Bio Inducer Surface, a pure Carbon coating which allows an increased haemo- and bio- compatibility of the nitinol platform

The clinical proof of Nitides rationale was shown by  Dierk Scheinert (University Hospital Leipzig, Leipzig, Germany) who presented the two-year results of the ILLUMINA first-in-human study which has enrolled 100 patients. In his talk he has highlighted that, although the study included complex patients and complex lesions (two patients Rutherford 5, lesions up to 140mm and 55% of moderate/heavy calcifications), the results at 24 months have been remarkable: 91.9% Freedom from device related MAE confirms long-term excellent SAFETY performance, while 93.1% Freedom from TLR states that the high product EFFICACY is maintained over long time.

After a discussion among all the speakers, Ralf Langhoff (Humboldt University Berlin,
Berlin, Germany) concluded this symposium saying “We now have a drug-based and stent based approach, even without a toxic PTX effect on the vessel wall: NiTiDES showed superb 24 month-data for a SFA DES strategy with the lowest TLR rate ever”.


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