Leipzig, January 31st, 2020 – Alvimedica sponsored a Lunch Symposium during LINC 2020 titled “Keep calm and NiTiDES: the first effective SFA Sirolimus eluting stent” that took place on Wednesday 29th of January from 12:35 to 13:30 – Halle Messe – Leipzig.
The session has provided to the vascular interventionalists the state of art in stent treatment of SFA lesions and has introduced NiTiDES - an innovative technology based on the sustain release of Sirolimus by a SX polymer-free platform.
In the first lecture Pr. Müller-Hülsbeck has underlined the need of Drug Eluting Technologies (DET) in the SFA district, demonstrating the key contribution provided by the Drug in optimizing device efficacy and identifying the key DES role in specific anatomical and pathological SFA settings. In light of today’s still doubtful safety concerns on Paclitaxel, Pr. 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’s worth to invest in innovative research in order to improve patient’s clinical outcome”.
Dr. Katsanos, indicating Sirolimus as the non-cytotoxic drug which may substitute Paclitaxel thanks to a more favorable biological profile and high anti-restenotic properties, has concluded his talk asking: “In light of Paclitaxel safety concerns in the lower limbs may Sirolimus be an alternative?”
After these two interesting presentations, Pr. Kahlberg 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 has been shown by Pr. Scheinert who has 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 (2pts 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 very lively discussion among all the speakers, Dr. Langhoff has concluded this highly attended 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”.
We are a global innovator of unique interventional medical devices, committed to continuing the development and manufacturing of globally recognized and highly innovative product portfolios in both endovascular and interventional cardiology.
We create the highest quality devices and technologies that answer patients’ un-met needs. Our teams are spread all around the world, with our main manufacturing plants in Italy and Turkey. Our driving passion is to improve the quality of life through innovative technology, creating a better future by investing in both clinical research and product development.
We firmly believe that by working with todays' leading physicians we will create highly effective solutions that meet today’s real unresolved patient needs. This collaboration is fundamental to us as a company, in order to present and discuss new treatment options.
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