The Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system (IDS) (Svelte Medical Systems) is to be launched commercially to select European accounts, specialising in transradial intervention (TRI).
According to Svelte, the Slender IDS is the world’s lowers profile drug eluting stent (DES), designed to reduce the catheter size and steps necessary to perform percutaneous coronary intervention (PCI).
Ferdinand Kiemeneij, who treated the first patient with the recently CE mark certified Slender IDS at Tergooi Hospital in Blaricum, The Netherlands, and was the first interventional cardiologist to perform PCI via transradial approach more than 20 years ago, says, “Slender IDS is a platform designed to improve patient care by breaking with current interventional standards.”
Giovanni Amoroso, a practicing interventional cardiologist at OLVG Hospital in Amsterdam, The Netherlands, and principal investigator of the DIRECT III post market study evaluating the clinical and procedural efficiency of Slender IDS in a real world setting added, “Downsizing is the future of interventional cardiology, and Slender IDS is the first ultra-low profile DES. The ability to reduce catheter size without compromise to performance minimises vascular trauma and enables use of the transradial approach, with all of its well-known clinical benefits, across broader subsets of patients. This makes for a much more pleasant patient experience.”
Kiemeneij and Amoroso are pioneers in the use of ‘slender’ techniques – the utilisation of lower profile devices and TRI to minimise trauma – for PCI in Europe. Together they host free-of-charge ‘slender’ workshops each month, inviting other practicing interventional cardiologists to learn the techniques and products used for ‘slender’ PCI, observe cases and manage same-day patient discharge.
By combining the latest guide wire, delivery balloon, stent and drug coating technologies into a single ‘all-in-one’ fixed-wire system, Slender IDS is designed to achieve low profiles and outperform other DESs. Asahi Act One wire technology provides precise steering while proprietary balloon control band (BCB) technology allows controlled balloon growth to safely perform direct stenting and high-pressure post-dilatation(s). Discreet drug coating, applied to a highly conformable cobalt chrome stent, is composed of the sirolimus drug and a natural, amino acid-based polyesteramide (PEA) bioresorbable drug carrier proprietary to DSM Biomedical. In the DIRECT I and II clinical studies, very low TLR was observed while no deaths or stent thromboses were reported beyond 3 years.
Svelte plans to begin enrolment of the DIRECT III post-market study during Q1 2016 to evaluate the procedural efficiencies and 12-month clinical outcomes of Slender IDS in real-world patient populations in Europe. A rapid-exchange DES system with proprietary technology designed to facilitate direct stenting will also be commercialised in Europe in 2016. Svelte further plans to commence an IDE study in support of US PMA approval in 2016.