Svelte Medical Systems Announces CE Mark Certification of DIRECT RX

Svelte Medical Systems Inc. has received CE Mark certification of the DIRECT Sirolimus-Eluting Coronary Stent Rapid-Exchange (RX) System for the treatment of coronary artery disease. The first patient to receive DIRECT RX was treated by Auke Weevers, M.D., a practicing interventional cardiologist at Albert Schweitzer Ziekenhuis in Dordrecht, The Netherlands.
 
“DIRECT RX provides smooth delivery and the stent conforms well to native vasculature. With its low-compliant balloon and bioresorbable drug coating technology designed for direct stenting, it is a nice compliment to SLENDER IDS which we have already integrated into our practice,” said Weevers.
 
Adding value in the modern healthcare environment requires new technologies to improve efficiency and reduce cost while enhancing patient outcomes and comfort. DIRECT RX employs DISCREET drug coating, composed of the well-studied drug sirolimus and a natural, amino acid-based polyesteramide (PEA) bioresorbable drug carrier proprietary to DSM Biomedical, a global developer of biomaterials science and regenerative medicine. This new class of drug coating is sufficiently tough to use with direct stenting, while higher durometer balloon material allows use of higher pressures to attain complete stent expansion, even in more highly calcified lesions. Use of the direct stenting approach minimizes use of pre-dilatation balloons, reducing the time and cost of stent procedures. DIRECT RX is specifically indicated for use with the direct stenting approach and in diabetic patients.
 
“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. “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.”
 
SLENDER IDS, which is commercially available at select accounts in Europe, combines Asahi guide wire technology and the same stent and balloon technology as DIRECT RX on a fixed-wire platform, creating an ‘all-in-one’ system to further streamline PCI. Both Svelte platforms will be evaluated in the large, randomized, controlled, multi-center OPTIMIZE study expected to commence next year in support of commercial approvals in the United States and Japan.
 
Headquartered in New Providence, N.J., Svelte Medical Systems is a privately-held developer of highly deliverable balloon expandable stents.