Svelte Medical Systems Announces CE Mark Certification of DIRECT RX

October 24, 2016

NEW PROVIDENCE, N.J. – Svelte Medical Systems, Inc. today announced it 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, MD, 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 Dr. 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 leader in 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, Inc. “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 US and Japan.

About Svelte Medical Systems

Headquartered in New Providence, New Jersey, Svelte Medical Systems (www.sveltemedical.com) is a privately-held company engaged in the development of highly deliverable balloon expandable stents. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits, are forward-looking statements. A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings, could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

For additional information please contact Jack Darby, President and CEO, Svelte Medical Systems, Inc., via e-mail jdarby@sveltemedical.com or phone 908-264-2012.