US-based Svelte Medical Systems has secured CE Mark for its Slender sirolimus-eluting coronary stent on a wire integrated delivery system (IDS) to treat coronary artery disease (CAD).
Slender IDS, which is the first advance in stent delivery since the rapid exchange catheter, is claimed to be the world's lowest profile drug-eluting stent (DES). It will be used to perform percutaneous coronary intervention (PCI) and transradial intervention (TRI) in patients.
Integrating DSM Biomedical's Asahi guide wire technology, Slender IDS will improve direct stenting, helping interventional cardiologists to reduce steps, time and costs from stenting procedures.
Asahi Act One wire technology provides precise steering, while the system's balloon control band (BCB) technology enables controlled balloon growth to safely carry out direct stenting and high-pressure post-dilatations.
Belgium-based Middelheim Hospital Antwerp Cardiovascular Institute co-director Stefan Verheye said: "Slender IDS is an entirely new approach to coronary stenting, offering unique clinical and procedural benefits, which we look forward to integrating into our practise.
"No reports of stent thrombosis dating back nearly four years to the first-in-man study are reassuring signals relating to safety, and product efficacy appears as good as any current generation DES.
"The unique attributes of this product help us in our ongoing efforts to optimise patient care."
Slender IDS also features Discreet drug coating, which is comprised of sirolimus and natural amino acid-based polyesteramide (PEA) bioresorbable drug carrier proprietary to DSM Biomedical.
Svelte Medical Systems president Jack Darby said: "Adding value in the modern healthcare environment requires new technologies to improve efficiency and reduce cost, while enhancing patient outcomes and comfort.
"Slender IDS is a highly differentiated platform delivering value to all constituents involved in coronary stenting, patients, physicians, providers and payers."
Initially, the company intends to commercialise Slender IDS in select European countries, and plans to begin an IDE study in support of PMA approval next year.