Svelte Medical, a company with offices in New Providence, NJ and Brussels, Belgium, won the European CE Mark for its DIRECT Sirolimus-Eluting Coronary Stent Rapid-Exchange (RX) System. 
The implant features sirolimus embedded within a proprietary amino acid-based polyesteramide material that slowly biodegrades while letting the drug seep out. The system can be used for direct stenting, without a separately delivered balloon, since its own high pressure balloon and the tough coating allow for thorough expansion of the blocked lumen. This can reduce procedure times and lead to better results for patients while allowing for faster turnover in the cath lab.
“With more than four years of follow-up in clinical studies demonstrating no cases of stent thrombosis and low rates of neointimal proliferation, our DES continues to demonstrate exceptional and sustained outcomes. DIRECT RX compliments our SLENDER IDS technology, providing a more conventional stent delivery platform for cases where our stent-on-a-wire technology may not be optimally suited,” said Jack Darby, President and CEO of Svelte Medical Systems, in a statement. “Svelte DES technologies can now be used to treat all lesions suitable for coronary stenting. We look forward to bringing this technology to more patients in Europe.”
Product page: DIRECT RX…