Svelte Medical Systems has obtained CE mark approval for its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system (IDS) to treat coronary artery disease.
Slender IDS is claimed to be the world’s lowest profile drug-eluting stent (DES) that 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 enhance direct stenting, helping interventional cardiologists to reduce steps, time and cost 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-dilatation(s).
Slender IDS also features Discreet drug coating, which is comprised of well-studied drug sirolimus and natural amino acid-based polyesteramide (PEA) bioresorbable drug carrier proprietary to DSM Biomedical.
Svelte Medical Systems president and CEO 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."
The company will initially commercialize Slender IDS in select European countries, and plans to begin an IDE study in support of PMA approval in 2016.
Image: Micrograph of a coronary artery with the most common form of coronary artery disease. Photo: courtesy of Nephron.